Cefiderocol and Ampicillin-sulbactam vs. Colistin or Colistin-meropenem for Carbapenem Resistant Acinetobacter Baumannii Bacteremia or Hospital-acquired Pneumonia: Controlled Clinical Study With Historical Controls (CASCADE)

Patients with bloodstream infections, hospital acquired pneumonia or ventilator-associated pneumonia caused by carbapenem-resistant Acinetobacter baumannii (CRAB) treated with cefiderocol combined with ampicillin sulbactam will be compared to patients treated treated with colistin alone or colistin combined with meropenem.

Start Date30 May 2024

Sponsor / Collaborator

Rambam Health Care Campus

[+2]

NCT06086626 / RecruitingPhase 2

A Multicenter, Single-arm, Open-label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Cefiderocol in Hospitalized Pediatric Patients From Birth to < 3 Months of Age With Suspected or Confirmed Aerobic Gram-negative Bacterial Infections

The primary purpose of this study is to understand the pharmacokinetics (PK) of single and multiple doses of cefiderocol in children from birth to less than 3 months of age with suspected or confirmed aerobic Gram-negative bacterial infections.

Start Date14 Mar 2024

Sponsor / Collaborator

Shionogi, Inc.

JPRN-UMIN000053151 / SuspendedNot Applicable

Fetroja for Intravenous Drip Infusion Regular Drug Use-results Survey - Fetroja for Intravenous Drip Infusion Regular Drug Use-results Survey

Start Date20 Dec 2023

Sponsor / Collaborator

Shionogi & Co., Ltd.

100 Clinical Results associated with Cefiderocol Sulfate Tosylate

100 Translational Medicine associated with Cefiderocol Sulfate Tosylate

100 Patents (Medical) associated with Cefiderocol Sulfate Tosylate

621

Literatures (Medical) associated with Cefiderocol Sulfate Tosylate

01 Mar 2024·Journal of global antimicrobial resistance

The occurrence of the carbapenemase gene, blaNDM-5, on a transmissible IncX3 plasmid in multidrug-resistant Escherichia coli isolated from a farm dog

Article

Author: Kassem, Issmat I ; Oueslati, Saoussen ; Osman, Marwan ; Naas, Thierry ; Daaboul, Dina ; Dabboussi, Fouad ; El Omari, Khaled

OBJECTIVES:

In-depth phenotypic and genomic analyses on a carbapenem-resistant Escherichia coli isolate, recovered from the faeces of a farm dog in Lebanon, focusing on its antimicrobial resistance (AMR) patterns and the underlying resistome.

METHODS:

E. coli strain EC-106 was identified using MALDI-TOF-MS. Analyses using Carba NP, immunochromatographic assay NG Carba5, and other antimicrobial susceptibility testing were performed. Whole-genome sequencing (WGS) using the Illumina technology and different software available at the Center of Genomic Epidemiology wwere used to predict the resistome, sequence type (ST), plasmid types, and virulence genes.

RESULTS:

Susceptibility testing revealed that E. coli EC-106 was multi-drug resistant, including against newer antimicrobials such as imipenem-relebactam (MIC = 16 µg/mL), meropenem-vaborbactam (MIC = 16 µg/mL), and ceftazidime-avibactam (MIC > 32 µg/mL), but remained susceptible to aztreonam (MIC = 0.12 µg/mL), aztreonam-avibactam (MIC = 0.06 µg/mL), and cefiderocol (MIC = 0.5 µg/mL). WGS analyses showed that E. coli EC-106 carried 13 acquired resistance genes associated with resistance to β-lactams (bla_NDM-5 and bla_TEM-1B), aminoglycosides (aac(3)-IId, aph(3')-Ia, aadA1, and aadA2), tetracyclines (tetA), amphenicols (partial catA1), macrolides (mphA), sulphonamides (sul1 and sul3), trimethoprim (dfrA12), and quaternary ammonium compounds (partial qacE). The bla_NDM-5 was located on an IncX3 plasmid. The isolate was predicted to be a human pathogen (92.9%) and belonged to ST1011.

CONCLUSION:

To our knowledge, this is the first report of the detection of an IncX3 plasmid carrying the bla_NDM-5 gene in animals in Lebanon, highlighting the severe AMR challenges in the country. Taken together, our current and previous findings suggest that bla_NDM-5 might be spreading in different hosts and genetic backgrounds across clinical and non-clinical settings.

01 Mar 2024·Journal of global antimicrobial resistance

First detection in Spain of NDM-1-producing Pseudomonas aeruginosa in two patients transferred from Ukraine to a university hospital

Article

Author: Cobo, Javier ; Cabello, Margarita ; Herrador-Gómez, Pedro M ; Gioia, Francesca ; Hernández-García, Marta ; Cantón, Rafael ; Ponce-Alonso, Manuel ; Ruiz-Garbajosa, Patricia

OBJECTIVES:

Carbapenemase-mediated carbapenem resistance in Pseudomonas aeruginosa is a relevant health problem. We detected for the first time in Spain two clinical NDM-producing P. aeruginosa (NDM-Pa) isolates in two Ukrainian patients admitted to our hospital between April and August 2022.

METHODS:

Antimicrobial susceptibility was studied by microdilution and MIC gradient strips (EUCAST-2022 criteria). Carbapenemase genes were detected by the Xpert Carba-R and immunochromatography assays. WGS (Illumina and Oxford-Nanopore) was also performed.

RESULTS:

In May 2022, we detected an NDM-Pa in a sternotomy wound in a patient. In June-2022, a second NDM-Pa along with an OXA-48-Klebsiella pneumoniae (OXA-48-Kp) isolate was detected in a mandibular abscess from an unrelated patient. Moreover, an NDM+OXA-48-K. pneumoniae (NDM+OXA-48-Kp) was also found in a rectal sample of this patient. Both patients had undergone surgery in Ukraine before their transfer to our hospital. NDM-Pa isolates were resistant to all tested antimicrobials with the exception of aztreonam (MIC = 8 mg/L), colistin (MIC =2 mg/L) and cefiderocol (MIC range = 0.75-2 mg/L). WGS confirmed that both P. aeruginosa isolates were NDM-1 producers, belonged to ST773 and shared an identical resistome. bla_NDM-1 was located on a ∼117-Kb chromosomally integrated integrative conjugative element (ICE). OXA-48-Kp and NDM+OXA-48-Kp belonged to ST147 and contained bla_OXA-48 on an identical ∼300-Kb IncHIB-plasmid. bla_NDM-1 was located on a 51-Kb IncFIB-plasmid only found in NDM+OXA-48-Kp.

CONCLUSIONS:

This is the first description of NDM-Pa in Spain. We highlight the threat of further cross-border dissemination of NDM-1 through P. aeruginosa along with K. pneumoniae high-risk clones also carrying OXA-48, which draws a complex epidemiological scenario.

01 Mar 2024·Drug resistance updates : reviews and commentaries in antimicrobial and anticancer chemotherapy

Dynamic within-host cefiderocol heteroresistance caused by blaSHV-12 amplification in pandrug-resistant and hypervirulent Klebsiella pneumoniae sequence type 11

Article

Author: Yang, Ping ; Shen, Ning ; Liu, Chao ; Lu, Ming ; Jiang, Fan ; Du, Pengcheng ; Du, Chunjing ; Yi, Juan

AIMS:

Although cefiderocol (FDC) is not prescribed in China, FDC-resistant pandrug-resistant hypervirulent Klebsiella pneumoniae (PDR-hvKp) is emerging. In this study, we performed FDC susceptibility testing of clinical Kp isolates to explore the prevalence of FDC-resistant isolates and the mechanism of FDC-resistance.

METHODS:

We retrospectively selected 151 carbapenem-resistant Kp isolates to assess FDC susceptibility. Seven isolates harboring bla_SHV-12 from two patients were enrolled for whole-genome sequencing. The antimicrobial resistance, virulence, bla_SHV-12 expression, and fitness costs in different media were examined. The amplification of bla_SHV-12 was further investigated by qPCR and long-read sequencing.

RESULTS:

The 151 isolates showed a low MIC₅₀/MIC₉₀ (1/4 mg/L) of FDC. The seven isolates were ST11 PDR-hvKp, and two represented FDC-resistance (MIC=32 mg/L). The IncR/IncFII plasmids of two FDC-resistant isolates harbored 6 and 15 copies of bla_SHV-12, whereas four FDC-susceptible isolates carried one copy and one harbored three copies. These bla_SHV-12 genes concatenated together and were located within the same 7.3 kb fragment flanked by IS26, which contributed to the increased expression and FDC resistance without fitness costs. The amplification of bla_SHV-12 and FDC resistance could be induced by FDC in vitro and reversed during continuous passage.

CONCLUSIONS:

The amplification of bla_SHV-12 and the consequent dynamic within-host heteroresistance are important concerns for the rational application of antibiotics. Long-read sequencing might be a superior way to detect resistance gene amplification rapidly and accurately.

News (Medical) associated with Cefiderocol Sulfate Tosylate

30 May 2024

·www.biospace.com

Qpex Biopharma, a Shionogi Group Company, Receives an Additional $10M Award by BARDA as Part of Qpex’s Partnership to Advance its Portfolio of Antibiotics Addressing Drug-Resistant Infections

SAN DIEGO--(BUSINESS WIRE)-- QPex Biopharma, Inc., a Shionogi Group Company, (hereafter “Qpex”) today announced the exercise of a $10 million option from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services, to support the advancement of the company’s antibiotic clinical development program. The option was awarded under the company’s existing contract with BARDA that provides up to $132 million in support to advance development of the portfolio of new therapies. “This award follows the important progress made in our programs since our merger with Shionogi last year,” said Michael N. Dudley, Pharm.D., President and CEO of Qpex. “We are grateful for the opportunity to build on our longstanding partnership with BARDA and to continue making progress on our development program as part of a leading global organization with a strong record discovering, developing and commercializing innovative anti-infective products.” The BARDA award will be used to advance xeruborbactam, an investigational beta-lactamase inhibitor, including supporting clinical studies in both IV and oral combinations for infections caused by drug-resistant gram-negative bacteria. “The urgent, global threat of antimicrobial resistance demands innovation,” said John Keller, Ph.D., Senior Executive Officer, Senior Vice President, R&D Supervisory Unit at Shionogi. “Antibiotic drug development is not keeping pace with resistance. Between Qpex’s promising pipeline and Shionogi’s decades of successful infectious disease R&D, our work has the potential to accelerate critically needed solutions for treating drug-resistant infections worldwide.” According to the Centers for Disease Control (CDC), more than 2.8 million antibiotic-resistant infections arise annually in the U.S.1 Among the most severe and difficult-to-treat infections are caused by drug-resistant gram-negative bacteria, several of which are targeted by the Qpex portfolio. Qpex was acquired by Shionogi Inc., a U.S. subsidiary of Shionogi & Co., Ltd., in 2023, bringing together world-class leadership teams and bolstering existing research capabilities and expertise that strengthen Shionogi’s longstanding global efforts to develop critically needed antimicrobials. The Qpex senior leadership team worked together for more than a quarter century, and they have completed four regulatory approvals in the past decade. The Qpex team continues to make progress, having advanced three products to U.S. investigational new drug (IND) application during the company’s first three years of operations. About Qpex Qpex Biopharma, Inc. is a resistance-focused infectious disease company on a mission to make both a dramatic and sustainable improvement in patient care across both inpatient and outpatient settings. Advancing a robust portfolio of best-in-class, clinical-stage products, the company’s lead program are based on xeruborbactam, an investigational ultra-broad-spectrum beta-lactamase inhibitor discovered by Qpex scientists. For more information, please visit and follow us on Twitter and LinkedIn. About Qpex and BARDA Partnership Qpex scientists and clinicians have an extensive track-record of successfully working in public-private partnerships, including a partnership with BARDA that led to the first approved antibiotic drug product under BARDA’s Broad Spectrum development programs in 2017. Qpex’s current partnership with BARDA is advancing xeruborbactam-based products S-649228 (cefiderocol + xeruborbactam IV) and S-743229 (ceftibuten oral + xeruborbactam oral prodrug). The development of these products in Qpex’s portfolio is funded in whole or in part with federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, BARDA, under OTA number HHSO100201600026C. To date, BARDA has awarded $92 million and provided technical support. If all options are awarded, the agreement would provide up to $132 million in support for the development of a portfolio of new antibiotics to fight drug-resistant gram-negative infections. Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. References CDC. Antibiotic Resistance Threats in the United States, 2019. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2019.

16 May 2024

·www.outsourcing-pharma.com

Inceptua improves access to medicine for serious gram-negative bacterial infections in LATAM

While antimicrobial resistance is on the rise, a greater number of people still succumb to infections caused by drug-sensitive bacteria. The study reveals that ongoing development of drug resistance is unavoidable, driven by the large populations of pathogens and their exposure to antibiotics. Furthermore, the researchers say, opportunistic pathogens will continue to endanger patients with weakened immune systems, even if they are susceptible to existing antibiotics according to clinical microbiology tests. These issues are interconnected and are likely to intensify as the human population ages, becomes more densely packed, and faces disruptions like war, extreme weather events, or a decline in living standards. Now Inceptua Group, a global pharmaceutical service company, has announced the expansion of its Early Access Program for cefiderocol to include eligible patients in Argentina, Chile, Colombia, Guatemala, Mexico, and Panama. This initiative is in partnership with Shionogi & Co. Ltd. and approved by local regulatory authorities. Shionogi will supply US-labeled cefiderocol through the Inceptua Early Access Program on a case-by-case basis to patients outside of clinical trials. Serious gram-negative bacterial infections “Inceptua is pleased to announce the expansion of this Early Access Program to Latin America to allow physicians the opportunity to access this medicine for use with appropriate patients with certain serious gram-negative bacterial infections,” says Stuart Bell, executive vice president, Inceptua Early Access. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Cefiderocol is a small molecule siderophore cephalosporin antibiotic developed by Shionogi for treating serious gram-negative infections. It penetrates the outer cell membrane of gram-negative pathogens by binding to ferric iron and being actively transported into bacterial cells. This allows it to reach high concentrations in the periplasmic space, where it inhibits cell wall synthesis. While cefiderocol is not yet approved for commercial use in Latin America, it has received approval from the US FDA in 2019, the European Medicines Agency (EMA) in 2020, and the Japanese Ministry of Health, Labor, and Welfare in 2023. Inceptua and Shionogi have collaborated since 2020 to make cefiderocol available through an Early Access program, initially starting in Europe and subsequently expanding into Canada and the Asia Pacific region. To date, nearly 1,000 patients have accessed cefiderocol through this program. Making medicines available for those with limited options Early Access Programs, also known as expanded access, managed access, compassionate use, and named patient supply, provide a compliant route for making medicines available to patients who either have limited or no alternative treatment options or have exhausted all other available treatments in their country of residence. In the US, cefiderocol is indicated for patients 18 years and older for treating complicated urinary tract infections (cUTIs), including pyelonephritis, and hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible gram-negative microorganisms such as Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa, among others. Inceptua Early Access offers strategic advice, design, facilitation, and implementation of global early access programs, distributing unlicensed and other medicines worldwide. Partnering with pharma and biotech companies, it has global reach, allowing patients access to potentially life-saving medicines. It has offices in eight countries and a global warehousing and distribution network and continues bringing promising medicines to patients. Inceptua Clinical Trial Supply provides clinical trial supply services, including comparator sourcing, packaging, labeling, storage, and distribution. With more than 25 years of experience and global operations across Europe, North America, and Asia, Inceptua serves life science companies of all sizes.

Drug ApprovalClinical StudyQualified Infectious Disease Product

26 Apr 2024

·www.biospace.com

Bruker Further Enhances Clinical Microbiology & Infection Diagnostics Portfolio at ESCMID Global 2024 Conference

New MBT Pathfinder® IVD robot for automated MALDI Biotyper® target preparation New LiquidArray® MTB-XDR panel for simultaneous detection of M. tuberculosis complex bacteria, and their resistances to five WHO-recommended second-line drugs against multidrug-resistant tuberculosis Pending ELITech acquisition has received all regulatory clearances; closing now expected in the second quarter of 2024 BARCELONA, Spain--(BUSINESS WIRE)-- At the ESCMID Global 2024 conference, Bruker is enhancing its innovative diagnostic solutions in microbial identification, antimicrobial susceptibility testing (AST), early sepsis diagnostics, and other infectious disease assays. Simplifying microbiology and infectious disease diagnostics and workflows in the clinical laboratory is a key goal for Bruker in support of earlier and improved patient treatment decisions. This press release features multimedia. View the full release here: MBT Pathfinder® IVD with Feeder IVD (Photo: Business Wire) Microbial identification – towards automated sample preparation The latest MALDI Biotyper® workflow uses MBT Compass HT IVD software to increase throughput up to 600 samples per hour, and automated instrument tuning via IDealTune™. An optional workflow now offers semi-automated sample preparation via the MBT Pathfinder® IVD robot to avoid time-consuming, repetitive and error-prone manual tasks. Sepsis – when every minute counts When the correct antibiotic treatment for sepsis is given quickly, outcomes can improve dramatically. The IVD-CE MALDI Biotyper®, used in conjunction with the MBT Sepsityper® IVD Kit, can identify pathogens within 20 minutes from a positive blood culture bottle. Bruker offers additional clinical workflows for rapid functional antibiotic resistance testing, like the MBT STAR®-Carba IVD assay for the detection of carbapenemase activity. Antimicrobial susceptibility testing (AST) AST can indicate which antimicrobial regimen is effective for patients. Bruker’s UMIC® tests deliver accurate results for single antibiotics and combinations, and the MICRONAUT range offers AST of multiple antibiotics in a single test in a user-friendly workflow in compliance with CLSI/EUCAST recommendations. The UMIC® portfolio covers five antibiotics and combinations, namely colistin, piperacillin-tazobactam, vancomycin/teicoplanin, daptomycin and cefiderocol. In addition, Bruker is developing the new MBT-fAST assay for rapid AST of gram-negative bacteria from positive blood cultures directly on the MALDI Biotyper® platform. The MBT-fAST clinical studies are planned for the second half of 2024. Bruker also intends concurrent clinical studies for IVDR certification of lipid A-based colistin resistance detection. This and the on-going development of microbial species and subspecies differentiation based on lipid patterns will further enhance the value of the MALDI Biotyper® sirius system for clinical laboratories. The MALDI Biotyper® sirius stands out as the first MALDI-TOF mass spectrometry system for microbial identification that uses the negative ion mode for microbial lipid analysis. Currently, this feature is for Research Use Only (RUO), setting the stage for forthcoming clinical applications. Outbreak control The Bruker IR Biotyper® enables efficient microbial strain typing of bacteria and yeasts for real-time epidemiological surveillance for a range of disease-causing pathogens. During outbreak scenarios within hospitals, the IR Biotyper can help prevent the spread of hospital-acquired infections (HAI). The IR Biotyper® for hospital hygiene and infection control can be combined with the MALDI Biotyper® for microbial species identification. LiquidArray® – next-generation syndromic panels The new LiquidArray® Gastrointestinal syndromic panel facilitates the simultaneous detection of up to 26 pathogens responsible for gastroenteritis. This streamlines clinical decision-making by allowing the simultaneous analysis of multiple targets from a single sample. The rise of multidrug-resistant and extensively drug resistant M. tuberculosis strains has added complexity to TB diagnosis and treatment – and global travel is causing re-emergence in formerly low risk countries. Bruker’s new multiplex mycobacteria test LiquidArray® MTB-XDR VER 1.0, detects TB-causing bacteria of the M. tuberculosis complex and identifies resistance to five WHO-recommended second-line drugs. Dr. Wolfgang Pusch, President of the Bruker Microbiology & Infection Diagnostics division, commented: “Bruker is committed to innovation in routine microbiology and infectious disease testing. This includes nearly universal microbial identification with the MALDI Biotyper®, rapid blood culture analysis with the MBT Sepsityper® IVD Kit, early implementation of diagnostics for new antibiotics with our UMIC® portfolio, real-time epidemiological surveillance with the IR Biotyper®, and syndromic panels with our LiquidArray® assay portfolio.” Pending ELITechGroup Acquisition Regulatory Clearances As announced on February 28, 2024, Bruker Corporation has signed a Share Purchase Agreement to acquire ELITechGroup, excluding the ELITech clinical chemistry business. All regulatory clearances for this acquisition have now been received, and closing of the acquisition is expected during Q2 2024, subject to remaining closing conditions. About Bruker Corporation – Leader of the Post-Genomic Era (Nasdaq: BRKR) Bruker is enabling scientists and engineers to make breakthrough post-genomic discoveries and develop new applications that improve the quality of human life. Bruker’s high performance scientific instruments and high value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular, and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity, and customer success in post-genomic life science molecular and cell biology research, in applied and biopharma applications, in microscopy and nanoanalysis, as well as in industrial and cleantech research, and next-gen semiconductor metrology in support of AI. Bruker offers differentiated, high-value life science and diagnostics systems and solutions in preclinical imaging, clinical phenomics research, proteomics and multiomics, spatial and single-cell biology, functional structural and condensate biology, as well as in clinical microbiology and molecular diagnostics. For more information, please visit . View source version on businesswire.com: Contacts Trade Press & Customer Contact: Philip Perry Senior Vice President, Marketing and Product Management Bruker Microbiology & Infection Diagnostics Division T: +49-172-313-7216 E: philip.perry@bruker.com Investor Contact: Justin Ward Sr. Director, Investor Relations & Corporate Development Bruker Corporation T: +1 (978) 313-5800 E: Investor.Relations@bruker.com Source: Bruker Corporation Smart Multimedia Gallery Photo MBT Pathfinder® IVD with Feeder IVD (Photo: Business Wire) Photo LiquidArray® MTB-XDR VER 1.0 (Photo: Business Wire) Logo View this news release and multimedia online at:

Acquisition

100 Deals associated with Cefiderocol Sulfate Tosylate

External Link

KEGG	Wiki	ATC	Drug Bank
D11013	Cefiderocol Sulfate Tosylate	J01D	DB14879

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Infectious Diseases	JP	Shionogi Pharma, Inc.	30 Nov 2023
Hospital-acquired pneumonia	US	Shionogi, Inc.	25 Sep 2020
Klebsiella Infections	US	Shionogi, Inc.	25 Sep 2020
Pneumonia, Ventilator-Associated	US	Shionogi, Inc.	25 Sep 2020
Serratia Infections	US	Shionogi, Inc.	25 Sep 2020
Gram-Negative Bacterial Infections	EU	Qualicaps Netherlands BV	23 Apr 2020
Gram-Negative Bacterial Infections	IS	Qualicaps Netherlands BV	23 Apr 2020
Gram-Negative Bacterial Infections	LI	Qualicaps Netherlands BV	23 Apr 2020
Gram-Negative Bacterial Infections	NO	Qualicaps Netherlands BV	23 Apr 2020
Pyelonephritis	US	Shionogi, Inc.	14 Nov 2019
Urinary Tract Infections	US	Shionogi, Inc.	14 Nov 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hospital acquired bacterial pneumonia	Phase 3	US	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	JP	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	BE	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	CA	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	CZ	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	EE	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	FR	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	GE	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	DE	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	HU	Shionogi, Inc.	24 Oct 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05395104 (CTgov)	Phase 1	-	14	Cefiderocol+Midazolam	gbfzbgwzrb(wkfyxdqawz) = juzjmbfoja yrbxzouoog (folqtjzkyr, xfksutpbyu - fvhhjmtkwg) View more	-	14 Dec 2023
NCT03032380 (APEKS-NP, Pubmed) Manual	Phase 3	Healthcare-Associated Pneumonia	-	Linezolid+Cefiderocol	ikpxbftjbl(rpzzrywrci) = nhauxhygov whqvhjopay (bwjnqaprkm ) View more	Non-inferior	13 Jan 2022
				Linezolid+meropenem	ikpxbftjbl(rpzzrywrci) = crtrfxczyj whqvhjopay (bwjnqaprkm ) View more
NCT02714595 (CREDIBLE-CR, Pubmed \| Lancet Infect Dis) Manual	Phase 3	Infectious Diseases	152	cefiderocol	gdaywxbnpk(soqhogigll) = rgebvovums hmyqrwuxyq (sdyadmwzco, 23.2 ~ 65.5) View more	Similar	01 Feb 2021
				best available therapy	gdaywxbnpk(soqhogigll) = vsucnqeonx hmyqrwuxyq (sdyadmwzco, 17.7 ~ 71.1) View more
NCT03032380 (APEKS-NP, CTgov)	Phase 3	Hospital acquired bacterial pneumonia \| Pneumonia, Ventilator-Associated \| Hospital-acquired pneumonia ... View more	300	Cefiderocol+Linezolid (Cefiderocol)	xmkqhjreqy(oeyhbrbgod) = hkzyzpocot cbdwhxstjd (gwdkqwjnsp, lrtbfzwcaa - zazxhicawo) View more	-	13 Nov 2020
				Meropenem+Linezolid (Meropenem)	xmkqhjreqy(oeyhbrbgod) = rncrkgeztr cbdwhxstjd (gwdkqwjnsp, ipflwtndfg - acpnbjpwav) View more
NCT03862040 (CTgov)	Phase 1	Pneumonia, Bacterial	7	Standard of Care Antibiotic+Cefiderocol	uyaewcjkiw(ygbppjlgqu) = cellqnfjbh awjxwxskbc (smpnonnhkt, oydhxewmxq - mteosmbwyz) View more	-	05 Nov 2020
NCT02321800 (Pubmed) Manual	Phase 2	Urinary Tract Infections Gram-negative	452	Cefiderocol	wnyyjxkuij(rpzmavgwaq) = chpcwhnibu opcmoffxmg (zpxnoffjgx ) View more	Positive	01 Dec 2018
				imipenem-cilastatin	wnyyjxkuij(rpzmavgwaq) = lmucyixduk opcmoffxmg (zpxnoffjgx ) View more

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