A Randomized Controlled Trial of Alternating Irrigation of Vancomycin Hydrochloride and Tobramycin Sulfate in Patients Undergoing Two-Stage Exchange Arthroplasty for Periprosthetic Joint Infection (PJI) of the Hip or Knee

Study Type: A multi-site, parallel group, randomized trial.
Study Objectives: The objective is to evaluate safety and determine preliminary efficacy of VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days). Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 90 days, consisting of a revision prosthesis implanted at Stage 2, patient survival, absence of reoperation and absence of periprosthetic joint infection (PJI). Secondary objectives are to evaluate superiority at 365 days in a composite endpoint of Overall Success, and in separate secondary endpoints for quality of life and patient survival. The exploratory objective is to compare Experimental and Control Arms in exploratory endpoints.
Follow-up: Patients will be evaluated at 90-, 180-, and 365-day follow-up visits.

Start Date01 Nov 2021

Sponsor / Collaborator

Osteal Therapeutics, Inc.

NCT03721328

/ CompletedPhase 2

A Phase 2 Multicenter Feasibility Trial to Evaluate Safety and Efficacy in Patients Treated for Hip or Knee Prosthetic Joint Infection (PJI) With Alternating Irrigation of Vancomycin Hydrochloride (HCl) and Tobramycin Sulfate in Two-Stage Exchange Arthroplasty

Study Type
Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial.
Primary Study Objective
The objective of the study is to determine the safety profile of local antibiotic irrigation for the treatment of PJI.
Primary Outcome Measure
The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions.
Follow-up
Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 12 months from initial surgery.

Start Date26 Oct 2018

Sponsor / Collaborator

Osteal Therapeutics, Inc.

NCT03066453

/ TerminatedPhase 3IIT

Evaluation of an Antibiotic Treatment With 14 Days of Intravenous Tobramycin Versus the Same Antibiotic Associated With 5 Days of Intravenous Tobramycin Followed by Tobramycin Aerosol for 9 Days in Cystic Fibrosis.

The aim of this study is to investigate the efficacy of antibiotic therapy with any antibiotic (IV) and IV (Nebcin®) tobramycin for 5 days followed by Solution for nebuliser inhalation (Tobi®) for 9 days and antibiotic cures using 14 days of tobramycin IV. In the case of positive results, the reduction of the duration of IV treatment of tobramycin from 14 days to 5 days would limit the risk of toxicity.

Start Date13 Jun 2017

Sponsor / Collaborator

Centre Hospitalier Universitaire de Lille

100 Clinical Results associated with Tobramycin Sulfate

100 Translational Medicine associated with Tobramycin Sulfate

100 Patents (Medical) associated with Tobramycin Sulfate

16,003

Literatures (Medical) associated with Tobramycin Sulfate

01 Apr 2025·Food Science and Biotechnology

Biofilm formation, slime production, and antibiotic susceptibility properties of the Bacillus cereus group isolated from fresh vegetables in the Republic of Korea

Author: Yoon, Jae-Hyun ; Song, Hana ; Lee, Sun-Young

This study aimed to characterize the ability of the Bacillus cereus group isolated from conventionally, organically or pesticide-freely grown vegetables to form biofilms with regard to cell surface hydrophobicity (CSH), slime production, and antibiotic susceptibility.Cellular properties (biofilm formation, CSH, and slime production) were measured using an in vitro microplate assay with crystal violet staining, adhesion to hydrocarbons assay, and Congo red broth method, resp.Consequently, 16, 16, and 16 B. cereus strains were isolated from conventionally, organically, and pesticide-freely grown vegetables, resp., and 16 (33%) B. cereus isolates were highly biofilm-pos. producers.CSH values dramatically varied, ranging from 19 to 74%, among the B. cereus isolates.Addnl., 9, 8, and 8 B. cereus strains isolated from conventionally, organically, and pesticide-freely grown vegetables, resp., were identified to be slime-pos. producers.According to the disk diffusion method, 19 and 41 B. cereus isolates were highly resistant to ampicillin and penicillin, resp.

01 Apr 2025·Talanta

Colorimetric aptasensor for tobramycin based on a highly stabilized aptamer-enhanced enzyme-mimicking activity of iron oxide/graphene oxide nanospheres

Article

Author: Barimah, Alberta Osei ; Peng, Chifang ; Mao, Minxin ; Tai, Shengmei ; Sun, Chengdong ; Wang, Zhouping ; Agyekum, Akwasi Akomeah ; Ding, Tao

Antibiotic contaminants in food are associated with detrimental health issues, and thus, the design of rapid and reliable detection methods to monitor them is in high demand. Although colorimetric aptamer sensing methods can achieve accurate and quick visual read-out analysis, they still have morphological defects that affect the detection efficiency and stability of the aptasensor. Hence, a simple and highly selective iron oxide/graphene oxide (Fe₃O₄/GO) nanospheres was developed and modified with an aptamer as nanozymes for colorimetric detection of tobramycin (Tob). Due to the electrostatic and π-π stacking interaction between the aptamer and the spherical Fe₃O₄/GOs nanozyme, the catalytic activity of the nanozyme was enhanced by the robust affinity between the aptamer and the 3,3',5,5'-tetramethylbenzidine (TMB) substrate. However, the presence of Tob could obstruct the catalytic activity through the specific binding of aptamer to Tob and the detachment of aptamer from the surface of the Fe₃O₄/GO, causing a low catalytic activity. Based on this strategy, a visual and quantitative detection for Tob was achieved with a detection limit of 70.7 nM. The proposed aptasensor demonstrated high selectivity, ease of operation, and potential application in food samples with satisfactory recoveries of 98.4-108.5 %. Therefore, this proposed method has great prospects for monitoring food safety and could be applied for sensing varied antibiotics by just switching the target-specific aptamer.

01 Apr 2025·Journal of Fish Diseases

Molecular Identification of Spironucleus vortens From the Digestive Tract of Discus (Symphysodon discus Heckel, 1840) and Its Association With Mixed Bacterial Coinfection

Article

Author: Guz, Leszek ; Puk, Krzysztof ; Pastuszka, Anna

ABSTRACTThis study presents the first case in Poland of isolation and molecular identification of the Spironucleus vortens parasite from the digestive tract of diseased ornamental fish belonging to the species discus fish (Symphysodon discus Heckel, 1840). Recently, an increasing percentage of fish submitted for testing to the Department of Biology and Fish Diseases, have been observed that show typical symptoms of hole‐in‐the‐head disease, therefore it is important to have accurate information about this disease. In preparation of this work, two fish were studied. The polymerase chain reaction (PCR) used a pair of primers designed specifically for this experiment. The amplification product was sequenced and the partial sequence of small ribosomal subunit (18S rRNA) was deposited in the GenBank database. The obtained nucleotide sequence showed a high percentage of identity with the compared sequence of the S. vortens reference strain (98.52%). Additionally, the presence of potentially dangerous bacteria belonging to four species, namely Citrobacter braakii, Acinetobacter lwoffi, Pseudomonas putida and Comamonas testosteroni was confirmed in the material collected from the tested fish. Bacterial isolates were examined biochemically. An antibiotic susceptibility testing showed that in three of the four isolates there appeared resistance to the drugs used.Trial Registration: Clinical trial registration was not required for this study.

News (Medical) associated with Tobramycin Sulfate

14 Nov 2024

·www.globenewswire.com

Osteal Therapeutics Announces Positive 12-Month Results from the APEX Clinical Trial Program at the 2024 American Association of Hip and Knee Surgeons (AAHKS) Annual Meeting

Outcomes at 12 months demonstrate a statistically significant net treatment effect of 19% compared to the standard of care two-stage exchange arthroplasty and highlight a 71% reduction in PJI burdenDALLAS, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Osteal Therapeutics, Inc. (“Osteal”), a clinical-stage biopharmaceutical company developing a new category of combination drug/device therapies for orthopedic infections, announced positive 12-month results from the two APEX (Abbreviated Protocol for Two Stage Exchange) clinical trials of VT-X7 KIT (vancomycin hydrochloride for irrigation; tobramycin sulfate for irrigation/irrigation system) (“VT-X7”) in patients with periprosthetic joint infections (“PJI”) of the hip or knee. The two prospective, randomized, comparative studies evaluated the efficacy of a rapid (7-day) exchange arthroplasty with intra-articular antibiotic irrigation versus the current standard of care, two-stage exchange arthroplasty. Results were featured at the 2024 American Association of Hip and Knee Surgeons (AAHKS) annual meeting and were presented by Dr. Nicolas S. Piuzzi, MD, of the Cleveland Clinic Foundation in Cleveland, Ohio. The APEX clinical program enrolled 152 patients across 23 centers in the U.S., with 76 patients treated in each study arm. Results demonstrated a statistically significant net treatment effect at 12-months of 19% (MSIS Tier 1, VT-X7: 71% vs. Control: 52%). Additionally, the median time to revision arthroplasty was significantly shorter at 7 days in VT-X7 patients compared to 98 days in patients with standard two-stage exchange. Of those patients completing revision arthroplasty (VT-X7: 100% vs. Control: 82%), patients treated with VT-X7 had a shorter overall procedure time by 62 minutes compared to patients treated with two-stage exchange. When considering the overall burden of PJI to the patients during the study follow-up period (i.e. time spent without a permanent implant and/or time spent as a failure), VT-X7 reduced PJI burden by 71% compared to standard two-stage exchange. Overall, the 12-month results demonstrated both a statistically significant and clinically meaningful treatment effect with VT-X7 compared to standard two-stage exchange. “A periprosthetic joint infection presents a significant challenge, with treatment often requiring multiple surgeries and prolonged rounds of antibiotics, which can profoundly disrupt a patient’s life. The APEX clinical program results are impressive, demonstrating a clinical advantage of rapid exchange arthroplasty with target site irrigation and providing surgeons with a promising, transformative approach to treating PJI, one that addresses the need to expedite infection eradication and allow patients to reclaim their lives.” says Dr. Piuzzi, Principal Investigator for the APEX-2 clinical study. About Periprosthetic Joint Infection (PJI) Affecting over 40,000 people in the U.S. annually, PJI is a rare and potentially devastating complication of joint replacement surgery in which pathogenic bacteria colonize the joint prosthesis, forming difficult-to-remove structures called biofilms. Biofilm infections are challenging to resolve, requiring long, invasive and expensive treatments that are often unsuccessful, resulting in high rates of permanent disability and early death. Recent retrospective analyses demonstrate that the current gold standard for treatment of PJI, two-stage exchange arthroplasty, takes an average of 16 weeks and has a success rate under 50% after 12 months, highlighting the unmet need for faster and more efficacious treatment options. About VT-X7 KIT VT-X7 KIT (vancomycin hydrochloride and tobramycin sulfate for irrigation/irrigation system) (“VT-X7”) is a novel drug/device combination product designed to deliver therapeutic concentrations of vancomycin and tobramycin, two well-established, broad-spectrum antibiotics, directly to the joint space and surrounding tissue to treat PJI. VT-X7 is a 7-day therapy designed to address the unmet clinical need for a rapid, reliable treatment for these challenging infections. In clinical studies of VT-X7, 100% of patients were treated and received a new permanent joint prosthesis in seven days with >90% remaining infection-free after one year. The US Food and Drug Administration has granted VT-X7 Breakthrough Therapy, Orphan Drug, Fast Track and Qualified Infectious Disease Product designations. This initial application of VT-X7 represents a first-of-its-kind, multibillion-dollar opportunity to dramatically improve outcomes for a serious unmet medical need in PJI. About Osteal Therapeutics, Inc. Osteal Therapeutics is a privately held, clinical-stage biopharmaceutical company developing novel musculoskeletal therapeutics to treat orthopedic infections and their consequences. The company is leveraging the ability of concentrated, locally delivered antimicrobials to treat the bacterial biofilms typically responsible for musculoskeletal infections while minimizing off-target tissue exposure and associated adverse effects. Osteal employs a low-risk development strategy by using approved drugs with long histories of safety and efficacy as candidates for new routes of local delivery. The company’s lead candidate, VT-X7 KIT, is in late-stage clinical development to treat periprosthetic joint infections, a serious complication of joint replacement surgery. For more information, please visit: www.ostealtx.com Corporate Contact: Todd SaundersVice President of MarketingOsteal Therapeutics, Inc.Phone: 469-809-2630Email: info@ostealtx.com

Clinical ResultFast TrackOrphan DrugBreakthrough TherapyQualified Infectious Disease Product

05 Aug 2024

·www.globenewswire.com

Osteal Therapeutics Presents Positive Six-Month Results from the APEX Clinical Trial Program at the 34th Annual Musculoskeletal Infection Society Meeting

The six-month efficacy endpoint of overall success showed a statistically significant improvement over standard of care, two-stage exchange arthroplastyDALLAS, Aug. 05, 2024 (GLOBE NEWSWIRE) -- Osteal Therapeutics, Inc. (“Osteal”), a clinical-stage biopharmaceutical company developing a new category of combination drug/device therapies for orthopedic infections, presented positive results from the two APEX (Abbreviated Protocol for Two Stage Exchange) randomized controlled clinical trials of the VT-X7 KIT (vancomycin hydrochloride and tobramycin sulfate for irrigation/irrigation system) (“VT-X7”) in patients with periprosthetic joint infections (“PJI”) of the hip or knee. Results were presented by Dr. Nicolas S. Piuzzi, MD of the Cleveland Clinic Foundation in Cleveland, Ohio at the 34th Annual Musculoskeletal Infection Society meeting. The two APEX clinical trials, consisting of more than 150 patients, demonstrated VT-X7 met the six-month efficacy endpoint, achieving a statistically significant improvement in overall success with a net treatment effect of 41% in patients treated with VT-X7 versus standard of care two-stage exchange arthroplasty. All VT-X7 patients received a permanent implant at Stage 2 versus 75% of control arm patients. The median time to Stage 2 surgery was also significantly shorter, at 7 days, compared to 102 days in the control arm. “The six-month results of the APEX clinical trials are highly encouraging. PJI is a debilitating condition associated with morbidity and mortality, and VT-X7 is a groundbreaking approach to its treatment. This therapy has the potential to transform current, highly variable treatment outcomes by offering a very effective solution in a considerably shorter timeframe. This is very promising from both the patients’ and surgeons’ perspectives, with the potential to significantly enhance both quality of life and treatment success.” says Dr. Piuzzi, Principal Investigator for the APEX-2 clinical study. About Periprosthetic Joint Infection (PJI) Affecting over 40,000 people in the U.S. annually, PJI is a rare and potentially devastating complication of joint replacement surgery in which pathogenic bacteria colonize the joint prosthesis, forming difficult-to-remove structures called biofilms. Biofilm infections are challenging to resolve, requiring long, invasive and expensive treatments that are often unsuccessful, resulting in high rates of permanent disability and early death. Recent retrospective analyses demonstrate that the current gold standard for treatment of PJI, two-stage exchange arthroplasty, takes an average of 16 weeks and has a success rate under 50% after 12 months, highlighting the unmet need for faster and more efficacious treatment options. About VT-X7 KIT VT-X7 KIT (vancomycin hydrochloride and tobramycin sulfate for irrigation/irrigation system) (“VT-X7”) is a novel drug/device combination product designed to deliver therapeutic concentrations of vancomycin and tobramycin, 2 well-established, broad-spectrum antibiotics, directly to the joint space and surrounding tissue to treat PJI. VT-X7 is a 7-day therapy designed to address the unmet clinical need for a rapid, reliable treatment for these challenging infections. In clinical studies of VT-X7, 100% of patients were treated and received a new permanent joint prosthesis in seven days with >90% remaining infection-free after one year. The US Food and Drug Administration has granted VT-X7 Breakthrough Therapy, Orphan Drug, Fast Track and Qualified Infectious Disease Product designations. This initial application of VT-X7 represents a first-of-its-kind, multibillion-dollar opportunity to dramatically improve outcomes for a serious unmet medical need in PJI. About Osteal Therapeutics, Inc. Osteal Therapeutics is a privately held, clinical-stage biopharmaceutical company developing novel musculoskeletal therapeutics to treat orthopedic infections and their consequences. The company is leveraging the ability of concentrated, locally delivered antimicrobials to treat the bacterial biofilms typically responsible for musculoskeletal infections while minimizing off-target tissue exposure and associated adverse effects. Osteal employs a low-risk development strategy by using approved drugs with long histories of safety and efficacy as candidates for new routes of local delivery. The company’s lead candidate, VT-X7 KIT, is in late-stage clinical development to treat periprosthetic joint infections, a serious complication of joint replacement surgery. For more information, please visit: www.ostealtx.com Corporate Contact: Todd SaundersVice President of MarketingOsteal Therapeutics, Inc.Phone: 469-809-2630Email: info@ostealtx.com

Clinical ResultFast TrackOrphan DrugQualified Infectious Disease ProductBreakthrough Therapy

06 Jun 2024

·www.globenewswire.com

Osteal Therapeutics Closes $50M Series D Financing to Support Approval and Commercial Launch of Lead Candidate

Financing led by Zimmer Biomet with participation from existing investors Johnson & Johnson Innovation – JJDC, Inc., Gideon Strategic Partners, and HM Capital. Proceeds will support NDA submission and commercial launch of lead candidate, VT-X7, a 7-day treatment for periprosthetic joint infection. June 05, 2024 -- Osteal Therapeutics, Inc. (“Osteal”), a clinical-stage biopharmaceutical company developing a new category of combination drug/device therapies for orthopedic infections, announced today the completion of an oversubscribed $50 million Series D preferred stock equity financing. Zimmer Biomet led the round, joined by returning investors Johnson & Johnson Innovation – JJDC, Inc., Gideon Strategic Partners, and HM Capital. In conjunction with the financing, a representative of Zimmer Biomet will join Osteal’s Board of Directors. The proceeds of the financing will be used to advance the development of Osteal’s portfolio of therapies, including the submission of a New Drug Application (NDA) for, and accelerated commercial launch of, VT-X7 for the treatment of periprosthetic joint infection (PJI) of the hip and knee. VT-X7 has been the subject of two multicenter, randomized, controlled trials, APEX and APEX-2. APEX-2 recently met its primary endpoint and will be completed in late 2024. The study builds upon the safety and efficacy evidence obtained from APEX, a similarly designed clinical study that successfully met its primary endpoint in 2023. Both studies were designed in close consultation with the FDA, which previously granted VT-X7 Breakthrough Therapy, Orphan Drug, Fast Track, and Qualified Infectious Disease Product designations. The company expects to seek FDA approval upon completion of APEX-2. “This round of financing represents an inflection point in the company’s progress towards introducing VT-X7 to the market,” said David Thompson, Chairman and Chief Executive Officer. “From the beginning, Osteal has been extremely fortunate to have the support of a world-class group of financial and strategic partners who share our vision and recognize the tremendous impact our programs will have on patient care. I am delighted to welcome Zimmer Biomet as a partner and look forward to working closely with their exemplary team.” Affecting over 40,000 people in the U.S. annually, PJI is a rare and potentially devastating complication of joint replacement surgery in which pathogenic bacteria colonize the joint prosthesis, forming difficult-to-remove structures called biofilms. Biofilm infections are challenging to resolve, requiring long, invasive and expensive treatments that are often unsuccessful, resulting in high rates of permanent disability and early death. Recent retrospective analyses demonstrate that the current gold standard for treatment of PJI, two-stage exchange arthroplasty, takes an average of 16 weeks and has a success rate under 50% after 12 months, highlighting the unmet need for faster and more efficacious treatment options. VT-X7 (vancomycin hydrochloride and tobramycin sulfate for irrigation/VT-X7 irrigation system) is a novel drug/device combination product designed to deliver therapeutic concentrations of vancomycin and tobramycin, well-established, broad-spectrum antibiotics, directly to the joint space and surrounding tissue to treat PJI. VT-X7 is a seven-day therapy designed to address the unmet clinical need for a rapid, reliable treatment for these challenging infections. In clinical studies of VT-X7, 100% of patients were treated and received a new permanent joint prosthesis in seven days with >90% remaining infection-free after one year. The US Food and Drug Administration has granted VT-X7 Breakthrough Therapy, Orphan Drug, Fast Track and Qualified Infectious Disease Product designations. This initial application of VT-X7 represents a first-of-its-kind, multibillion-dollar opportunity to dramatically improve outcomes for a serious unmet medical need. Osteal Therapeutics is a privately held, clinical-stage biopharmaceutical company developing novel musculoskeletal therapeutics to treat orthopedic infections and their consequences. The company is leveraging the ability of concentrated, locally delivered antimicrobials to treat the bacterial biofilms typically responsible for musculoskeletal infections while minimizing off-target tissue exposure and associated adverse effects. Osteal employs a low-risk development strategy by using approved drugs with long histories of safety and efficacy as candidates for new routes of local delivery. The company’s lead candidate, VT-X7, is in late-stage clinical development to treat periprosthetic joint infections, a serious complication of joint replacement surgery. For more information, please visit: www.ostealtx.com The content above comes from the network. if any infringement, please contact us to modify.

Fast TrackOrphan DrugQualified Infectious Disease Product

100 Deals associated with Tobramycin Sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
D02542	Tobramycin Sulfate	S01AA12 J01GB01	DB00684

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Infectious Lung Disorder	Liechtenstein	PARI Pharma GmbH	18 Mar 2015
Infectious Lung Disorder	Norway	PARI Pharma GmbH	18 Mar 2015
Infectious Lung Disorder	European Union	PARI Pharma GmbH	18 Mar 2015
Infectious Lung Disorder	Iceland	PARI Pharma GmbH	18 Mar 2015
Pseudomonas Infections	European Union	PARI Pharma GmbH	18 Mar 2015
Pseudomonas Infections	Norway	PARI Pharma GmbH	18 Mar 2015
Pseudomonas Infections	Liechtenstein	PARI Pharma GmbH	18 Mar 2015
Pseudomonas Infections	Iceland	PARI Pharma GmbH	18 Mar 2015
Cystic Fibrosis	Australia	Phebra Pty Ltd.	17 Jul 2009
Lower Respiratory Tract Infections	United States	Fresenius Kabi USA LLC	13 Jul 2004
Meningitis	United States	Fresenius Kabi USA LLC	13 Jul 2004
Peritonitis	United States	Fresenius Kabi USA LLC	13 Jul 2004
Sepsis	United States	Fresenius Kabi USA LLC	13 Jul 2004
Skin and skin structure infections	United States	Fresenius Kabi USA LLC	13 Jul 2004
Urinary Tract Infections	United States	Fresenius Kabi USA LLC	13 Jul 2004
Bacterial Infections	China	Tianjin Jinyao Pharmaceutical Co., Ltd.	01 Jan 1987
Bacterial Infections	China	Hunan Er-Kang Pharmaceutical Co., Ltd.	01 Jan 1987

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03721328 (CTgov)	Phase 2	Prosthetic joint infection \| Juvenile Polyposis Syndrome	15	tobramycin sulfate+vancomycin hydrochloride	uwwihqtrkn(ifnuyjyugt) = duqainwrwp sjttnmcwac (qsvepquixz, prptqbtlcn - qnpaifhehx) View more	-	09 Dec 2021
TIS I (VANTOBRA/Tolero) vs TIS II (TOBI/PARI LC PLUS) (ERS2013)	Not Applicable	-	-	TIS I (VANTOBRA/Tolero)	soofqwtlxz(ctljottfpz) = ptnqeqtekc gfupnialuc (aaudzzoncw ) View more	Positive	01 Sep 2013
	Not Applicable	-	-	TIS II (TOBI/PARI LC PLUS)	soofqwtlxz(ctljottfpz) = momzmjsqiz gfupnialuc (aaudzzoncw ) View more	Positive	01 Sep 2013

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