11% of the general population undergo total hip arthroplasty (THA) in their lifetime and 7% undergo total knee arthroplasty (TKA), with these rates expected to rise up to 50% by 2026. Periprosthetic joint infection (PJI) remains one of the most common complications, accounting for 30% of THA/TKA revision surgeries. Topical delivery of antibiotic powder may reduce the incidence of PJI but its potential drawbacks include wound healing complications, reduced osteoblast activity, third body wear, and antibiotic resistance. In THA and TKA, topical administration of vancomycin powder for the primary prevention of PJI has been studied in observational studies, but conclusions are limited due to the low incidence of PJI and high number of patients required to detect a significant difference. Investigators therefore propose a randomized controlled trial (RCT) investigating the impact of topical vancomycin compared to standard care on PJI rates following THA and TKA.
Aim: To determine whether topical vancomycin is a safe and effective intervention for the primary prevention of PJI after THA and TKA.
Study Design: This is a pilot multi-centre RCT to evaluate the study design and assess feasibility prior to implementation across Canada. Investigators aim to recruit 50 THA and 50 TKA patients.
Inclusion Criteria THA or TKA Patients aged 18 years or older Patients must complete 1 year follow-up Exclusion Criteria Patients undergoing surgery for inflammatory arthritis, post-traumatic arthritis, or avascular necrosis History or septic arthritis based on history or synovial aspirate Prior major operation on the affected joint Current immunosuppressive medications Vancomycin allergy or history of a vancomycin-related complication Recruitment: surgeons introduce study to the patients, research staff will conduct recruitment.
Intervention: Patients will be randomized preoperatively and remain blinded to their treatment arm. Patients allocated to the control group will have all standard care infection prophylaxis interventions. Patients allocated to the vancomycin group will undergo all the standard care measures in addition to 1g of powdered vancomycin applied to the wound.
Follow-up: Patients will complete follow-up at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year visits.
Primary outcome: PJI in the same joint. Secondary outcome: PJI in THA and TKA subgroups:
Reoperation on the same joint Superficial and non-infectious wound complications All complications

Start Date30 Dec 2025

Sponsor / Collaborator

University of Calgary

NCT06794944

/ Not yet recruitingPhase 4IIT

Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients with Inflammatory Bowel Disease

This is a randomized, double-blind study to assess the safety and efficacy of fidaxomicin compared to vancomycin for decolonization of C. difficile in IBD patients. A total of 60 patients who meet eligibility criteria will be randomized 1:1 to either the fidaxomicin or vancomycin arm. The vancomycin arm will receive a dose of 125 mg PO q 6 hours for 10 days. The fidaxomicin arm will receive 200 mg PO BID for 10 days. In order to ensure blinding, both antibiotics will be concealed in opaque 00 capsule shells. In addition, those in the fidaxomicin arm will receive 2 placebo capsules so that all participants will receive 4 capsules daily for 10 days. Microbiome assessment and C. difficile testing will be performed at baseline, day 5, day 10, and weeks 4, 8, and 26.

Start Date01 Sep 2025

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

NCT06567808

/ Not yet recruitingPhase 4

Prevention of Infections in Cardiac Surgery (PICS): a Cluster-randomized Factorial Cross-over Trial

The goal of this pragmatic, multi-centre factorial cluster randomized cross-over trial is to assess the efficacy of a combination of cefazolin plus vancomycin compared to cefazolin monotherapy, as well as a comparison of short versus long-term prophylaxis with four study arms: 1) cefazolin short-term, 2) cefazolin long-term, 3) cefazolin plus vancomycin short-term and 4) cefazolin plus vancomycin long-term.

Start Date01 May 2025

Sponsor / Collaborator

Hamilton Health Sciences Corporation

[+1]

100 Clinical Results associated with Vancomycin Hydrochloride

100 Translational Medicine associated with Vancomycin Hydrochloride

100 Patents (Medical) associated with Vancomycin Hydrochloride

57,166

Literatures (Medical) associated with Vancomycin Hydrochloride

31 Dec 2025·Journal of Pharmaceutical Policy and Practice

Article

Author: Ur Rehman, Naeem ; Maqbool, Sumeira ; Arif, Mehreen ; Hassan, Ali

Background:

Antibiotics are widely used medications among infectious disease patients; therefore, proper monitoring and assessment are critical for ensuring rational use. Antimicrobial stewardship addresses the rational and appropriate use of antibiotics, which reinforces overall health outcomes. Ongoing antimicrobial resistance scenarios are an alarming condition for healthcare, necessitating continued practice of such assessments.

Objectives:

To evaluate the use of antibiotics in patients with infectious diseases, implement and evaluate clinical pharmacy interventions that adhere to antimicrobial stewardship protocols.

Methods:

A before and after study was designed to evaluate clinical pharmacy and antimicrobial stewardship interventions for infectious disease patients at a tertiary care hospital in Lahore. A Performa was designed for manual data collection. Study first identified the signal of error, implemented intervention and noted post-interventional followups.

Results:

102 infectious disease cases were analyzed in total and proposed 136 interventions. Physicians accepted 66% of the interventions (90) and rejected the remaining ones as unjustified. The most accepted intervention was the spectrum-based choice (n = 30), followed by de-escalation of dose (n = 17). Use of ceftriaxone was very high (54 Pt.), followed by vancomycin (30 Pt.).

Conclusion:

Antimicrobial stewardship programmes are critical for any institution's proper health care system. It ensures proper antibiotic outflow to patients, thereby improving their health status. The role of pharmacists in establishing an AMS in a hospital setting is a highly commendable activity that enhances healthcare collaboration and outcomes. Clinical pharmacists should implement such activities to improve patient care.

31 Dec 2025·Gut Microbes

Clostridioides difficile binary toxin CDT induces biofilm-like persisting microcolonies

Article

Author: Chassaing, Benoit ; Altamirano-Silva, Pamela ; Dupuy, Bruno ; Crouzols, Aline ; Tinevez, Jean-Yves ; Chamorro-Rodriguez, Susan ; Lejal, Emilie ; Kim, Minhee ; Groussard, Déborah ; Hunault, Lise ; Peltier, Johann ; Mary, Héloïse ; Gobaa, Samy ; Meza-Torres, Jazmin

Clinical symptoms of Clostridioides difficile infection (CDI) range from diarrhea to pseudomembranous colitis. A major challenge in managing CDI is the high rate of relapse. Several studies correlate the production of CDT binary toxin by clinical strains of C. difficile with higher relapse rates. Although the mechanism of action of CDT on host cells is known, its exact contribution to CDI is still unclear. To understand the physiological role of CDT during CDI, we established two hypoxic relevant intestinal models, Transwell and Microfluidic Intestine-on-Chip systems. Both were challenged with the epidemic strain UK1 CDT⁺ and its isogenic CDT^- mutant. We report that CDT induces mucin-associated microcolonies that increase C. difficile colonization and display biofilm-like properties by enhancing C. difficile resistance to vancomycin. Importantly, biofilm-like microcolonies were also observed in the cecum and colon of infected mice. Hence, our study shows that CDT induces biofilm-like microcolonies, increasing C. difficile persistence and risk of relapse.

31 Dec 2025·ANNALS OF MEDICINE

Article

Author: Kaňková, Klára ; Kolek, Martin ; Ďuricová, Jana ; Brozmanová, Hana ; Motyka, Oldřich ; Šištík, Pavel ; Juřica, Jan ; Kacířová, Ivana

INTRODUCTION:

It is hypothesized that systemically administered antibiotics penetrate wound sites more effectively during negative pressure wound therapy (NPWT). However, there is a lack of clinical data from patients who receive NPWT for deep sternal wound infection (DSWI) after open-heart surgery. Here, we evaluated vancomycin penetration into exudate in this patient group.

PATIENTS AND METHODS:

For this prospective observational study, we enrolled 10 consecutive patients treated with NPWT for post-sternotomy DSWI. On the first sampling day, serum and exudate samples were synchronously collected at 0 (pre-dose), 0.5, 1, 2, 3 and 6 h after vancomycin administration. On the following three consecutive days, additional samples were collected, only before vancomycin administration.

RESULTS:

The ratio of average vancomycin concentration in wound exudate to in serum was higher for free (unbound) (1.51 ± 0.53) than for total (bound + unbound) (0.91 ± 0.29) concentration (p = 0.049). The percentage of free vancomycin was higher in wound exudate than serum (0.79 ± 0.19 vs. 0.46 ± 0.16; p = 0.04). Good vancomycin wound penetration was maintained on the following three days (vancomycin trough exudate-to-serum concentration ratio > 1). The total hospital stay was significantly longer in patients with DSWI (46 ± 11.6 days) versus without DSWI (14 ± 11.7 days) (p < 0.001). There was no in-hospital or 90-day mortality. Two patients experienced late DSWI recurrence. All-cause mortality was 4.8% during a median follow-up of 2.5 years.

CONCLUSION:

Vancomycin effectively penetrates wound exudate in patients receiving NPWT for DSWI after open-heart surgery.The protocol for this study was registered at ClinicalTrials.gov on July 16, 2024 (NCT06506032).

258

News (Medical) associated with Vancomycin Hydrochloride

18 Mar 2025

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Acurx Pharmaceuticals, Inc. Reports Fourth Quarter and Full Year 2024 Results and Provides Business Update

STATEN ISLAND, N.Y., March 18, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today certain financial and operational results for the fourth quarter and full year ended December 31, 2024. Highlights of the fourth quarter ended December 31, 2024, or in some cases shortly thereafter, include: In October 2024, we exhibited at ID Week in Los Angeles, which was the annual scientific conference of the Infectious Diseases Society of America and where Drs. Garey and Eubank, from the University of Houston School of Pharmacy, presented a scientific poster showing that in the Phase 2b clinical trial, ibezapolstat had comparable clinical cure and sustained clinical cure rates and safety profile to vancomycin. As previously reported, the overall observed Clinical Cure rate in the combined Phase 2 trials (Ph2a and Ph2b) in patients with CDI was 96% (25 out of 26 patients); AND 100% (25 of 25) of ibezapolstat-treated patients in Phase 2 (again, Phase 2a + 2b) who had Clinical Cure at End of Treatment, (or EOT), remained cured through one month after EOT, as compared to 86% (12 of 14) for the vancomycin patient group in Ph2b. Also, in a subset of ibezapolstat patients, 5 of 5 followed for 3 months after end of treatment (EOT) experienced no recurrence of infection. IBZ-treated patients showed decreased concentrations of fecal primary bile acids, and higher ratios of secondary to primary bile acids than vancomycin-treated patients. According to Dr. Garey: "These exciting results demonstrate two properties of ibezapolstat which may contribute to its anti-recurrence effect. First, the preservation and restoration of beneficial bacterial classes in the gut provide resistance to recolonization by C. difficile. Second, these data, presented for the first time, indicate that these beneficial bacteria known to metabolize primary to secondary bile acids persist in ibezapolstat-treated patients providing another important mechanism to prevent recurrent CDI." In November 2024, we announced Sponsorship and Participation in the Peggy Lillis Foundation Inaugural CDI Scientific Symposium and Presented an Ibezapolstat Ph2b Clinical Data Update. In January 2025, the Company announced it had closed a $2.5 million registered direct offering priced at the market under Nasdaq rules. Also in January 2025, we announced that we received positive regulatory guidance from the European Medicines Agency (EMA) for the ibezapolstat Phase 3 clinical trial program, which is aligned with FDA on matters of manufacturing, non-clinical and clinical aspects of the Phase 3 program. The EMA guidance also confirmed ibezapolstat's regulatory pathway for a Marketing Authorization Application to be filed by the Company after successful completion of the Phase 3 clinical trials. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program. In February 2024 and in March 2025, we announced new publications in the Journal of Antimicrobial Agents and Chemotherapeutics of two very important non-clinical studies which we believe we can leverage to show further positive differentiation for competitive advantage of IBZ vs all other antibiotics used for the first line therapy of C. difficile infection. And, for that matter, given our clinical results to date, we're hopeful that this anti-recurrence effect of IBZ could mitigate the need for expensive microbiome therapeutic agents to prevent recurrent CDI. In February 2025, we announced positive results from this first study, conducted by Dr. Justin McPherson from the University of Houston and funded by the National Institute of Allergy and Infectious Diseases (or NIAID). It was an in-silico study that predicted the microbiome-restorative potential of IBZ for treating CDI. Our scientific advisors consider this to be a major finding which provides a mechanistic explanation for IBZ's selectivity in that the predicted bactericidal interaction between IBZ and its target, the DNA pol IIIC enzyme, allows regrowth of gut microbes known to confer health benefits. The second study, conducted by Dr. Trenton Wolfe, from the University of Montana, was funded by the National Institute of Allergy and Infectious Diseases (NIAID), the National Cancer Institute (NCI), National Center for Advancing Translational Sciences (NCATS), and the Company. This study is the first ever head-to-head comparison of gut microbiome changes associated with IBZ when compared to other anti-CDI antibiotics in a germ-free mouse model. The data showed that changes in alpha and beta microbiome diversities following IBZ treatment were less pronounced compared to those observed in vancomycin (VAN)-or metronidazole (MET)-treated groups, complementing prior Phase 2 clinical findings showing IBZ's more selective antibacterial activity. Further, and very importantly, notable differences were observed between the microbiome of IBZ- and the fidaxomicin (FDX)-treated groups, which may allow for differentiation of these two anti-CDI antibiotics in future studies. These results establish IBZ's differentiating effects on the gut microbiome, indicating a more selective spectrum of microbiome alteration compared to broader-spectrum antibiotics like VAN and MET and a narrower spectrum of microbiome alteration compared to FDX. Also in February 2025, the Japanese Patent Office granted a new patent for our DNA polymerase IIIC inhibitors which expires in December 2039, subject to extension. This constitutes a significant building block for our ongoing development of ACX-375C, our pre-clinical antibiotic candidate targeting the treatment of MRSA, VRE and Anthrax infections. In March 2025, we announced the closing of a registered direct offering and concurrent private placement, raising gross proceeds of $1.1 million. Fourth Quarter and Full Year 2024 Financial Results Cash Position: The Company ended the year with cash totaling $3.7 million, compared to $7.5 million as of December 31, 2023. The Company raised a total of $6.6 million of gross proceeds under its ATM financing program for the year ended December 31, 2024. R&D Expenses: Research and development expenses for the three months ended December 31, 2024 were $0.8 million compared to $1.9 million for the three months ended December 31, 2023, a decrease of $1.1 million. The decrease was due primarily to a decrease in consulting related costs of $1.2 million, offset by an increase in manufacturing costs of $0.1 million. For the year ended December 31, 2024 research & development expenses were $5.4 million compared to $6.0 million for the year ended December 31, 2023, a decrease of $0.6 million. The decrease was primarily due to a $1.6 million decrease in consulting related costs, offset by a $1.0 million increase in manufacturing related costs. G&A Expenses: General and administrative expenses for the three months ended December 31, 2024 were $2.0 million compared to $3.2 million for the three months ended December 31, 2023, a decrease of $1.2 million. The decrease was primarily due to $0.5 million decrease in professional fees, a $0.5 million decrease in share-based compensation costs, and a $0.2 million decrease in employee compensation costs. For the year ended December 31, 2024, general and administrative expenses were $8.7 million compared to $8.5 million for the year ended December 31, 2023, an increase of $0.2 million. The increase was primarily due to $0.7 million increase in professional fees, a $0.3 million increase in legal fees, offset by a $0.6 million decrease in share-based compensation costs and a $0.2 million decrease in insurance costs. Net Income/Loss: The Company reported a net loss of $2.8 million or $0.16 per diluted share for the three months ended December 31, 2024 compared to a net loss of $5.1 million or $0.37 per diluted share for the three months ended December 31, 2023, and a net loss of $14.1 million or $0.87 per share for the year ended December 31, 2024, compared to a net loss of $14.6 million or $1.15 per share for the year ended December 31, 2023 for the reasons previously mentioned. The Company had 17,030,686 shares outstanding as of December 31, 2024. Conference Call As previously announced, David P. Luci, President and Chief Executive Officer, and Robert G. Shawah, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows: About Ibezapolstat Ibezapolstat is the Company's lead antibiotic candidate advancing to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome. In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI. About Acurx Pharmaceuticals, Inc. Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram-positive specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection is Phase 3 ready with plans in progress to begin international clinical trials next year. The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel. To learn more about Acurx Pharmaceuticals and its product pipeline, please visit . Forward-Looking Statements Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the year ended December 31, 2024, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law. Investor Contact: Acurx Pharmaceuticals, Inc. David P. Luci, President & Chief Executive Officer Tel: 917-533-1469 Email: [email protected] SOURCE Acurx Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Phase 2Clinical ResultFast TrackFinancial Statement

05 Mar 2025

·www.prnewswire.com

New Study Demonstrates Potential for Enhanced Accuracy of Blood Cultures with Steripath® Initial Specimen Diversion Device® (ISDD®) for Central Line Draws

SEATTLE, March 5, 2025 /PRNewswire/ -- Magnolia Medical Technologies, Inc., the pioneer in Initial Specimen Diversion Device® (ISDD®) technology, today announced groundbreaking new findings from an in-vitro study demonstrating that the Steripath® ISDD may improve the accuracy of blood cultures drawn directly from an existing central venous catheter (CVC). Conducted by researchers at the University of Nebraska Medical Center (UNMC) and published in a leading peer-reviewed medical journal, Infection Control & Hospital Epidemiology, the study, entitled "In Vitro assessment of effect of initial specimen diversion device on detection of central venous catheter contamination or colonization," represents the first published assessment of a closed-system, engineered diversion device for this application. Blood cultures drawn with standard method vs. cultures drawn using the Steripath ISDD were compared in a simulated CVC colonization and contamination model. The study highlights a critical advancement: the use of Steripath ISDD technology resulted in the detection of 100% of colonized CVCs while decreasing false-positive cultures by 56% (36% to 16%).1 This result underscores the potential role of the Steripath ISDD family in enhancing diagnostic precision for bloodstream infection detection, particularly for critically ill patients reliant on central venous catheters. "Accurately identifying patients with sepsis/bloodstream infection is critical and differentiating true bacteremia from blood culture contamination is vitally important. This study provides promising, new evidence that the Steripath ISDD may play a role in improving the accuracy of blood cultures for patients who require a culture drawn directly from a central vascular catheter," said Dr. Mark E. Rupp, Professor and Interim Chair, Department of Internal Medicine at the University of Nebraska Medical Center. "By ensuring that colonized catheters are accurately detected, and contamination events are mitigated, clinicians can make more informed treatment decisions, reduce unnecessary antibiotic use, and improve patient outcomes. The Steripath ISDD technology used for CVC cultures in this study improved relative specificity and based on these results, warrants further investigation in a prospective clinical trial." This latest research builds on the extensive clinical evidence already supporting the clinical impact of Steripath ISDD device families in preventing false-positive blood cultures for peripheral venipunctures and peripheral IV starts.2-7 A separate, landmark study conducted at Stanford University Medical Center demonstrated that the use of Steripath reduced blood culture contamination to 0% in over 11,200 blood cultures drawn, while also significantly decreasing false-positive central line-associated bloodstream infections (CLABSIs).3 The reduction in false-positive CLABSIs has profound implications for hospital quality metrics, antibiotic stewardship programs, and reimbursement under CMS' Value-Based Purchasing (VBP) Program. A Paradigm Shift for Blood Cultures For decades, clinicians have faced the challenge of differentiating true bloodstream infections that may progress to sepsis from contamination events, particularly when blood cultures are drawn from a central line, which are highly prone to contamination. The findings from the UNMC study provide evidence that Steripath ISDD technology could play a role in improving the diagnostic reliability of this critical microbiology test. "With the large body of evidence available in peer-reviewed studies and in best practice guidelines from CLSI and CDC, we are driving change to national standards for blood culture contamination rates," added Greg Bullington, CEO and Co-Founder of Magnolia Medical. "Hospitals can combine evidence-based best practice techniques with Steripath ISDD technology to improve the accurate detection of bloodstream infections that can progress to sepsis. This is not only better for patients but could also save the healthcare system billions of dollars annually." Magnolia Medical remains committed to revolutionizing blood culture collection with scientifically validated, clinically proven innovations. The company continues to partner with leading healthcare institutions to further research and expand access to Steripath ISDD technology nationwide. About Steripath The Steripath® Initial Specimen Diversion Device® platform offers the only family of FDA 510(k)-cleared, all-in-one engineered devices referenced to reduce blood culture contamination in the ENA, CLSI, CDC, INS, SHEA, ASM, IDSA, and AHRQ evidence-based best practice guidelines and strategy recommendations. These guidelines reference high-quality, technology-specific evidence generated with Steripath ISDD.8-16 To date, over 20 clinical studies, including nine peer-reviewed publications in leading clinical journals, have been completed supporting the clinical and cost effectiveness of Steripath.17 Steripath and Steripath Micro have been adopted by over 500 U.S. hospitals and healthcare systems to address the problem of blood culture contamination, which can lead to sepsis misdiagnosis resulting in unnecessary, prolonged, and harmful antibiotic treatment, extended length of hospital stay, false-positive CLABSIs, and wasted healthcare resources. About Magnolia Medical Technologies Magnolia Medical Technologies develops, manufactures, and markets innovative blood and bodily fluid collection devices to improve the accuracy, consistency, and predictability of critical laboratory tests. The company invented and patented the Initial Specimen Diversion Technique® (ISDT®) and Initial Specimen Diversion Device® (ISDD®) to prevent blood culture contamination. Magnolia Medical has built a robust intellectual property portfolio with nearly 200 issued patents and over 50 additional patent applications pending encompassing hundreds of devices and integrated diagnostic concepts and embodiments. For more information, visit . Rupp ME, Fey PD, Lyden E, Handke L. In vitro assessment of effect of initial specimen diversion device on detection of central venous catheter contamination or colonization. Infect Control Hosp Epidemiol. 2024;46(2):1-4. doi: 10.1017/ice.2024.220. Epub ahead of print. PMID: 39696936; PMCID: PMC11790329. Nielsen LE, Nguyen K, Wahl CK, et al. Initial Specimen Diversion Device® reduces blood culture contamination and vancomycin use in academic medical centre. J Hosp Infect. 2022;120:127-133. doi: 10.1016/j.jhin.2021.10.017. Epub 2021 Nov 13. PMID: 34780808. Tompkins LS, Tien V, Madison AN. Getting to zero: impact of a device to reduce blood culture contamination and false-positive central line-associated blood stream infections. Infect Control Hosp Epidemiol. 2022;1-5. doi:10.1017/ice.2022.284. Rupp ME, Cavalieri RJ, Marolf C, Lyden E. Reduction in blood culture contamination through use of Initial Specimen Diversion Device. Clin Infect Dis. 2017;65(2):201-205. doi:10.1093/cid/cix304. Bell M, Bogar C, Plante J, Rasmussen K, Winters S. Effectiveness of a novel specimen collection system in reducing blood culture contamination rates. J Emerg Nurs. 2018;44(6):570-575. doi:10.1016/j.jen.2018.03.007. Zimmerman FS, Assous MV, Zevin S, Wiener-Well Y. Reducing blood culture contamination using an Initial Specimen Diversion Device. Am J Infect Control. 2019;47(7):822-826. doi:10.1016/j.ajic.2018.12.004. Povroznik MD. Initial Specimen Diversion Device utilization mitigates blood culture contamination across regional community hospital and acute care facility. Am J Med Qual. 2022;37(5):405-412. doi: 10.1097/JMQ.0000000000000055. Epub 2022 Mar 30. PMID: 35353719; PMCID: PMC9426727. Vanhoy MA, Horigan A, Kaiser J, et al. Emergency Nurses Association (ENA). Clinical practice guideline: prevention of blood culture contamination. 2020. Blood Culture Contamination Prevention Actions: An Overview of Infection Control and Antibiotic Stewardship Programs Working with the Clinical Laboratory. 2022. CDC National Email Update to Clinicians. Clinicians: Use this guide to decrease blood culture contamination rates. July 2022. Principles and Procedures for Blood Cultures. 2nd Ed. CLSI Guideline M47. Clinical and Laboratory Standards Institute. 2022. Nickel B, Gorski LA, Kleidon, T, et al. Infusion therapy standards of practice, 9th edition. J Infus Nurs. 2024. Ku TSN, Al Mohajer M, Newton JA, et al. Improving antimicrobial use through better diagnosis: The relationship between diagnostic stewardship and antimicrobial stewardship. Infect Control Hosp Epidemiol. 2023;44(12):1901-1908. doi: 10.1017/ice.2023.156. Sautter RL, Parrott JS, Nachamkin I, et al. American Society for Microbiology evidence-based laboratory medicine practice guidelines to reduce blood culture contamination rates: a systematic review and meta-analysis. Clin Microbiol Rev, 2024; 37:e00087-24. . Miller JM, Binnicker MJ, Campbell S, et al. Guide to utilization of the microbiology laboratory for diagnosis of infectious diseases: 2024 update by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM). Clinical Infectious Diseases. 2024; ciae104. doi.org/10.1093/cid/ciae104. Agency for Healthcare Research and Quality (AHRQ). Strategies to prevent blood culture contamination. 2024. Retrieved on February 10, 2025 at Data on file. SOURCE Magnolia Medical Technologies WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultClinical Study

28 Feb 2025

·www.prnewswire.com

Acurx Pharmaceuticals to Discuss Fourth Quarter and Full Year 2024 Financial Results on March 18, 2025 Conference Call and Provide Business Update

STATEN ISLAND, N.Y., Feb. 28, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today that the Company will discuss its fourth quarter and full year 2024 financial results on Tuesday, March 18, 2025 at 8:00 am ET before the U.S. financial markets open. David P. Luci, President and Chief Executive Officer, and Robert G. Shawah, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows: About Ibezapolstat Ibezapolstat is the Company's lead antibiotic candidate preparing for international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome. Acurx previously announced that it had received positive regulatory guidance from the EMA during its Scientific Advice Procedure which confirmed that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement of the ibezapolstat Phase 3 program and if the Phase 3 program is successful, supports the submission of a Marketing Authorization Application (MAA) for regulatory approval in Europe. The information package submitted to EMA by the Company to which agreement has been reached with EMA included details on Acurx's two planned international Phase 3 clinical trials, 1:1 randomized (designed as non-inferiority vs vancomycin), primary and secondary endpoints, sample size, statistical analysis plan and the overall registration safety database. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI. About Acurx Pharmaceuticals, Inc. Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP). To learn more about Acurx Pharmaceuticals and its product pipeline, please visit . Forward-Looking Statements Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the year ended December 31, 2023, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law. Investor Contact: Acurx Pharmaceuticals, Inc. David P. Luci, President & CEO Tel: 917-533-1469 Email: [email protected] SOURCE Acurx Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Financial StatementFast TrackQualified Infectious Disease Product

100 Deals associated with Vancomycin Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00926	Vancomycin Hydrochloride	J01XA01 A07AA09 S01AA28	DB00512

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Clostridium difficile diarrhea	United States	Hikma Pharmaceuticals USA, Inc.	26 Aug 2021
Blepharitis	Japan	TOA Pharmaceuticals Co., Ltd.	16 Oct 2009
Conjunctivitis	Japan	TOA Pharmaceuticals Co., Ltd.	16 Oct 2009
Dacryocystitis	Japan	TOA Pharmaceuticals Co., Ltd.	16 Oct 2009
(non-specific) purulent meningitis	Japan	OHKURA Pharmaceutical Co., Ltd.	22 Oct 2004
Arthritis	Japan	OHKURA Pharmaceutical Co., Ltd.	22 Oct 2004
Empyema	Japan	OHKURA Pharmaceutical Co., Ltd.	22 Oct 2004
Endocarditis, Bacterial	Japan	OHKURA Pharmaceutical Co., Ltd.	22 Oct 2004
Hemorrhagic Septicemia	Japan	OHKURA Pharmaceutical Co., Ltd.	22 Oct 2004
Lung Abscess	Japan	OHKURA Pharmaceutical Co., Ltd.	22 Oct 2004
Neutropenia	Japan	OHKURA Pharmaceutical Co., Ltd.	22 Oct 2004
Osteomyelitis	Japan	OHKURA Pharmaceutical Co., Ltd.	22 Oct 2004
Pneumonia	Japan	OHKURA Pharmaceutical Co., Ltd.	22 Oct 2004
Secondary infection	Japan	OHKURA Pharmaceutical Co., Ltd.	22 Oct 2004
Bone and joint infections	United States	Baxter Healthcare Corp.	29 Apr 1993
Endocarditis	United States	Baxter Healthcare Corp.	29 Apr 1993
Infectious Diseases	United States	Baxter Healthcare Corp.	29 Apr 1993
Lower Respiratory Tract Infections	United States	Baxter Healthcare Corp.	29 Apr 1993
Sepsis	United States	Baxter Healthcare Corp.	29 Apr 1993
Skin and skin structure infections	United States	Baxter Healthcare Corp.	29 Apr 1993

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cystic Fibrosis	Phase 3	United States	Savara, Inc.	20 Sep 2017
Cystic Fibrosis	Phase 3	Canada	Savara, Inc.	20 Sep 2017
MRSA - Methicillin resistant Staphylococcus aureus infection	Phase 3	United States	Savara, Inc.	20 Sep 2017
MRSA - Methicillin resistant Staphylococcus aureus infection	Phase 3	Canada	Savara, Inc.	20 Sep 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06506032 (Pubmed \| Ann Med)	Not Applicable	Wound Infection	10	Vancomycin (Patients with Deep Sternal Wound Infection (DSWI))	qayuafobhg(iwogzbkpkf) = All-cause mortality was 4.8% during a median follow-up of 2.5 years lxmouayrci (ebvxxlhwhj ) View more	Positive	31 Dec 2025
NCT03617445 (CTgov)	Phase 2	Clostridium difficile infection	3	Oral Vancomycin placebo (FMT Oral Capsules/ Oral Vancomycin Placebo)	jhiajvgdbj = pjlqneejyk rpaywblofu (cizhinjovm, guhrdvvxzw - azcxlxyhqr) View more	-	09 Jan 2025
				FMT oral placebo+Oral Vancomycin (Placebo FMT Capsules/ Active Oral Vancomycin)	jhiajvgdbj = tkqralyhvn rpaywblofu (cizhinjovm, klhmtgqwks - zkvunhuxiv) View more
NCT05376228 (Pubmed \| J Crohns Colitis)	Not Applicable	Cholangitis, Sclerosing faecal calprotectin	15	Oral Vancomycin (OV) 125mg QID	dqkctkwjpr(untwmsltrv) = vfajjerucp qlswbfbmzu (hfhoorexmr )	Positive	14 Dec 2024
NCT02432807 (CTgov)	Phase 3	Conjunctivitis, Bacterial	303	Vancomycin 1.1% (Vancomycin 1.1%)	gbqadrscmj = bvnbontmcv qcpocmsctj (nyhzuagmdl, rijrohfklc - ayvsvfxoaq) View more	-	23 Oct 2024
				Placebo (Placebo)	gbqadrscmj = qeacafzufa qcpocmsctj (nyhzuagmdl, wzqumknhpa - cwylkcdgeb) View more
IBIS (UEGW2024)	Not Applicable	Infectious Diseases First line	489	Vancomycin	neqkzadmks(qysdbmwqct) = rvqqfunixr wgibtniazl (xfdwirinqn )	Positive	13 Oct 2024
				Metronidazole	neqkzadmks(qysdbmwqct) = holmgkbvny wgibtniazl (xfdwirinqn )
NCT04132427 (CTgov)	Phase 2	Gastrointestinal Diseases \| Pitt-Hopkins Syndrome	6	vancomycin, magnesium citrate, microbiota (Group A: Treatment)	kezoesnxce(jzldkikblj) = wdjthaqdrg dxjpdmzgkz (nihsakaelp, 2.5) View more	-	26 Aug 2024
				placebo vancomycin, real magnesium citrate, placebo microbiota (Group B: Placebo)	kezoesnxce(jzldkikblj) = gechnqtwlg dxjpdmzgkz (nihsakaelp, 0) View more
ATS2024	Not Applicable	-	-	Pharmacist-led vancomycin consult service	xdlchsuxrz(ztjctwoyoe) = ccylxsqubb sgbnmlzbet (sohrrptjup ) View more	-	19 May 2024
				Vancomycin (Standard of care)	xdlchsuxrz(ztjctwoyoe) = ekimsddccz sgbnmlzbet (sohrrptjup ) View more
ATS2024	Not Applicable	Anaphylaxis	-	Vancomycin	xuszadrqxk(dvpheoykfz) = Vancomycin induced anaphylaxis developing life-threatening disseminated intravascular coagulation and multiorgan failure resulting in sepsis pulkmkvlhv (yicpgzocwu )	-	19 May 2024
AAAAI2024	Not Applicable	Dermatitis, Atopic	-	antistaphylococcal drugs (Group 1 (positive initial BC for S.aureus))	lgfddwincb(ymhhlhkbda) = haxzelunvc jtlynhjqoo (hnrszgwzfe ) View more	-	23 Feb 2024
				antistaphylococcal drugs (Group 2 (negative BC for S.aureus))	lgfddwincb(ymhhlhkbda) = ofarqptguh jtlynhjqoo (hnrszgwzfe ) View more
NCT02692651 (Pubmed \| Clin Infect Dis) Manual	Phase 4	Clostridium difficile infection	144	Fidaxomicin	axuhcltptd(teyunqkigv) = gmngurzucb olohnydwxw (xesjsekeof ) View more	Negative	17 Feb 2024
				Vancomycin	axuhcltptd(teyunqkigv) = iywmfjvzwo olohnydwxw (xesjsekeof ) View more

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