Targeted Versus Standard Peri-operative Antibiotic Prophylaxis in Patients Colonized With Carbapenemase-producing Enterobacterales Undergoing Liver Transplantation: a Stepped Wedge Cluster Randomization Trial

This is a multicenter stepped-wedge cluster randomized trial, conducted over a 2-year period at three hospitals. The trial is structured into four phases, each lasting six months. During phase 1 (pre-rollout), all hospitals will use standard antibiotic prophylaxis for all patients. In each of phases 2 to 4, one hospital will switch to targeted antibiotic prophylaxis, so that by phase 4 all hospitals will be using it. The order in which hospitals switch is determined by computer-generated randomization performed centrally by an independent statistician, ensuring each hospital has an equal chance of switching at any given phase and minimizing selection bias.
The goal of this clinical trial is to learn whether targeted antibiotic prophylaxis works better than standard antibiotic prophylaxis at preventing infections in liver transplant patients who carry resistant bacteria called CPE (carbapenemase-producing Enterobacterales). It will also learn about the effects of these antibiotics on gut bacteria.
The main questions it aims to answer are:
* Does targeted antibiotic prophylaxis reduce the number of CPE infections occurring in the first two weeks after liver transplant, compared to standard prophylaxis?
* How do targeted and standard antibiotic prophylaxis affect the gut microbiome after transplant?
* Is there a link between achieving optimal antibiotic blood levels and the risk of developing an infection after transplant?
Researchers will compare targeted antibiotic prophylaxis (chosen based on the specific bacteria each patient carries) to standard antibiotic prophylaxis (used routinely at each hospital) to see which approach better prevents infection.
This study does not involve the administration of any drugs or instrumental examinations beyond those already part of standard clinical care at each center. However, additional blood tests will be performed by collecting one extra blood sample (and a bile sample, if the patient has a Kehr's tube, which is a drain placed in the bile duct after surgery) during blood draws already scheduled as part of routine clinical practice, in order to measure drug levels in the blood. Stool samples will also be collected specifically for the study to investigate the gut microbiome.

Start Date01 Oct 2026

Sponsor / Collaborator

IRCCS Azienda Ospedaliero-Universitaria di Bologna

NCT07431307

/ Not yet recruitingPhase 2

A Two-part Phase IIb Randomized, Multicenter, Open-label Comparative Study to Firstly Evaluate the Safety and Efficacy Trial of BV100 in Combination With Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol Versus Best Available Therapy in Patients With Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia and Bloodstream Infection, Suspected or Confirmed to be Due to Carbapenem-resistant Acinetobacter Baumannii Calcoaceticus Complex (CRABC), and Secondly to Evaluate the Pharmacokinetics of BV100 in Combination With Low Dose Polymyxin B Plus Cefideroc

This Phase IIb study aims to evaluate the safety and efficacy of BV100 in combination with low dose polymyxin B plus ceftazidime/avibactam or cefiderocol in patients with suspected or confirmed CRABC infections. The study is divided into two parts (Part A and Part B), recruiting in parallel. Approximately 10 subjects will be recruited in Part B, with enrollment ending once Part A enrollment is complete (at least 30 patients randomized to all of the three groups). Eligible patients, who have given informed consent, will be enrolled, and pre-treatment microbiology samples submitted to a local laboratory.

Start Date01 Jul 2026

Sponsor / Collaborator

BioVersys AG

NCT07465432

/ RecruitingPhase 4IIT

Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries

Cefiderocol is a powerful, broad spectrum antibiotic approved to treat hospital-acquired or ventilator associated pneumonia and urinary tract infections. Although cefiderocol has labeled dosing recommendations, including augmented renal clearance, patients with burn injury remain an unstudied population at high risk for MDR pathogens. The primary objective of this study is to evaluate the pharmacokinetic principles of cefiderocol in patients after acute burn injury. Findings from this study will determine the dose and interval necessary to maintain therapeutic concentrations of cefiderocol in patients after burn injury for adequate bactericidal activity, prevention of resistance, and treatment outcomes.

Start Date16 Feb 2026

Sponsor / Collaborator

University of Tennessee

[+1]

100 Clinical Results associated with Cefiderocol Sulfate Tosylate

100 Translational Medicine associated with Cefiderocol Sulfate Tosylate

100 Patents (Medical) associated with Cefiderocol Sulfate Tosylate

1,154

Literatures (Medical) associated with Cefiderocol Sulfate Tosylate

01 Oct 2026·INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS

Comment on "A multicenter, randomized, double-blind, imipenem/cilastatin-controlled clinical study of cefiderocol for the treatment of complicated urinary tract infections caused by gram-negative pathogens in Chinese adults"

Letter

Author: Li, Qiuqiong ; Luo, Hong ; Chai, Liying

01 Oct 2026·INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS

Carbapenem-resistant Enterobacterales across the UK: A nationwide study of carbapenemase testing and novel antimicrobial activity

Article

BACKGROUND:

Carbapenem-resistant Enterobacterales (CRE) are increasing in the UK, but the drivers of this rise and effective treatment options remain uncertain.

METHODS:

Ninety-seven acute National Health Service Trusts, including 192 UK hospitals, submitted data on 8840 consecutive, non-duplicate CRE (October 2023 to September 2024) and local laboratory methods.

RESULTS:

Predominant CRE species were Klebsiella pneumoniae (30.6%, 2709/8840), Escherichia coli (29.3%, 2592/8840), Enterobacter cloacae complex (22.2%, 1966/8840). Overall, 21.8% (1927/8840) of CRE were collected in outpatient settings. Overall, 85.5% (7279/8513) of CRE underwent carbapenemase detection testing, with significant variation depending on species, specimen type, and baseline antibiogram. Carbapenemases detected were OXA-48-like (22.3%, 1967/8840), NDM (18.6%, 1645/8840), KPC (9.2%, 817/8840), IMP (2.0%, 178/8840), VIM (0.7%, 62/8840), multi-carbapenemase producers (4.0%, 351/8840). Overall, 51.2% (4526/8840) of CRE were tested against ≥1 novel agent. In-house antimicrobial susceptibility testing availability was common for ceftazidime-avibactam (90.7%, 88/97) and cefiderocol (73.2%, 71/97), while less common for meropenem-vaborbactam (41.2%, 40/97), imipenem-relebactam (21.6%, 21/97), aztreonam-avibactam (11.3%, 11/97). OXA-48-like- (97.6%, 1138/1166) and KPC producers (96.2%, 429/446) remained susceptible to ceftazidime-avibactam; KPC producers to meropenem-vaborbactam (99.4%, 160/161) and imipenem-relebactam (98.4%, 62/63). Cefiderocol resistance was 32.4% overall and higher among NDM- (58.4%) and multi-carbapenemase producers (50.3%). Ceftazidime-avibactam plus aztreonam synergy was performed for 17.2% (286/1658) of aztreonam-resistant metallo-β-lactamase-producers; synergy was observed in 78.7% (225/286) of cases. Colistin resistance was 10.6% (153/1445) among non-intrinsically resistant species.

CONCLUSIONS:

Whilst most UK CRE are tested for carbapenemases, coverage gaps persist. The community burden of CRE is increasing. Cefiderocol resistance is concerningly high, particularly among metallo-β-lactamase-producers.

01 Oct 2026·INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS

Contribution of the Arg-33-His replacement in the histidine kinase CpxA to carbapenem and cefiderocol resistance in Serratia marcescens

Article

Author: Jacques, Sébastien ; Poyart, Claire ; Morand, Philippe ; Mammeri, Hedi ; Doloy, Alexandra ; Plainvert, Céline ; Hernandez Martinez, Miguel Angel ; Tazi, Asmaa

OBJECTIVE:

The Serratia marcescens ROT_R clinical isolate, which was resistant to almost all β-lactams, including cefiderocol (4 mg/L), was recovered from a neonate 2 months after the isolation of the S. marcescens ROT_S strain that was susceptible to extended-spectrum cephalosporins (ESCs). In this study, we attempted to decipher the mechanism of resistance displayed by the ROT_R isolate.

METHODS:

The genomes of ROT_S and ROT_R were sequenced using the Illumina and the Oxford Nanopore Technologies. Long and short reads were assembled together, giving rise to a circularized hybrid genome.

RESULTS:

Genomic comparison between ROT_S and ROT_R disclosed only one mutation (G98A) in the cpxA gene of ROT_R, which led to the Arg-33-His substitution in the histidine kinase of the two-component system CpxA/CpxR. The cpxA alleles of ROT_S and ROT_R were amplified and cloned, thus giving rise to the pCpxA_WT and pCpxA_R33H recombinant plasmids, respectively, which were subsequently introduced into the S. marcescens HatR recipient strain, which lacks functional CpxA. The S. marcescens HatR (pCpxA_R33H) recombinant clone, which produced the altered CpxA_R33H variant, differed from the S. marcescens HatR (pCpxA_WT) recombinant clone, which produced the wild-type CpxA, by enhanced MICs of carbapenems and ESCs, including cefiderocol (1 mg/L).

CONCLUSIONS:

This study demonstrates that CpxA alteration, such as Arg-33-His substitution, can contribute to cefiderocol resistance. Although it increases slightly the MIC of cefiderocol without resulting per se in clinical resistance, it can contribute, in combination with other additional mechanisms, to achieve a high level of resistance to this siderophore cephalosporin.

News (Medical) associated with Cefiderocol Sulfate Tosylate

17 Jul 2026

·www.shionogi.com

FDA Accepts Shionogi’s sNDA for Fetroja® (cefiderocol) for Use in Pediatric Patients with Serious Infections Caused by Susceptible Gram-negative Bacteria Submission intends to address a critical therapeutic gap for vulnerable young patients facing dr

OSAKA, Japan, July 17, 2026 –Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced the U.S. Food and Drug Administration (FDA) has accepted a Supplemental New Drug Application (sNDA) for Fetroja® (cefiderocol) for the treatment of pediatric patients (at least 26 weeks of gestational age) with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain Gram-negative microorganisms. The FDA has set an action date of February 23, 2027 under the Prescription Drug User Fee Act (PDUFA). The sNDA was submitted by Shionogi Inc., the U.S. subsidiary of Shionogi & Co., Ltd., and is supported by results from three clinical studies that investigated the safety, tolerability, pharmacokinetics and efficacy of cefiderocol in 154 children from birth (at least 26 weeks of gestational age) to less than 18 years of age, with cUTI, HABP/VABP and other infections caused by suspected or confirmed Gram-negative bacteria.[1],[2],[3] In 2023, cefiderocol was included in the World Health Organization’s PAediatric Drug Optimization (PADO) priority list, which identifies medicines most urgently needed for children, especially where there are gaps in dosing, safety data, or age‑appropriate formulations.[4] The expansion of Fetroja for pediatric HABP/VABP is supported by an ongoing contract with the U.S. Government through the Biomedical Advanced Research and Development Authority’s (BARDA) Project BioShield. This project has been funded with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50126C00004. Fetroja is approved in the U.S. for the treatment of adult patients with cUTIs, including pyelonephritis and HABP/VABP caused by suspected or confirmed Gram-negative bacterial infections.[5] For full Prescribing Information for Fetroja, including approved indications and Safety Information, please visit https://www.shionogi.com/content/dam/shionogi/si/products/pdf/fetroja.pdf. About Shionogi in Infectious Disease Over the past 70 years, Shionogi has discovered and commercialized six novel antibiotics. Today, our R&D story extends beyond antibiotics to include novel medications for HIV and influenza. Our global pipeline includes investigational agents to address global health challenges including antimicrobial resistance, COVID-19, influenza, rare fungal diseases and respiratory syncytial virus. As part of our commitment to addressing unmet medical needs, Shionogi partners with several non-governmental organizations to increase equitable access to our medications worldwide. Shionogi and Global Antibiotic Research and Development Partnership (GARDP) have a license agreement and Shionogi and GARDP have a collaboration agreement with the Clinton Health Access Initiative (CHAI) that aim to transform the landscape of access to antibiotics in most low-, lower middle- and upper middle-income countries, and select high-income countries. Shionogi ranked second among large research-based pharmaceutical companies in the Access to Medicine Foundation’s 2026 Antimicrobial Resistance (AMR) Benchmark, a global assessment of how leading pharmaceutical companies are tackling antimicrobial resistance and expanding responsible access to antibiotics worldwide. 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. Media Contacts: U.S.: ShionogiCommunications@shionogi.com Japan: https://www.shionogi.com/global/en/contact.html Europe: pressoffice@shionogi.eu 1. Clinical Trials.gov [Internet]. A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants. Available from: https://clinicaltrials.gov/study/NCT04215991 2. Clinical Trials.gov [Internet]. A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants. Available from: https://clinicaltrials.gov/study/NCT04335539 3. Clinical Trials.gov [Internet]. A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants. Available from: https://clinicaltrials.gov/study/NCT06086626 4. World Health Organization [Internet]. Towards investigation, development and introduction of cefiderocol in children: product brief. Available from: https://www.who.int/publications/i/item/9789240084599 5. Fetroja® Prescribing information. Available from: https://www.shionogi.com/content/dam/shionogi/si/products/pdf/fetroja.pdf. Accessed June 2026.

License out/inDrug Approval

16 Jul 2026

·www.biospace.com

FDA Accepts Shionogi’s sNDA for Fetroja® (cefiderocol) for Use in Pediatric Patients with Serious Infections Caused by Susceptible Gram-negative Bacteria

Submission intends to address a critical therapeutic gap for vulnerable young patients facing drug-resistant pathogens FLORHAM PARK, N.J.--(BUSINESS WIRE)--Shionogi Inc., a New Jersey-based subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced the U.S. Food and Drug Administration (FDA) has accepted a Supplemental New Drug Application (sNDA) for Fetroja® (cefiderocol) for the treatment of pediatric patients (at least 26 weeks of gestational age) with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain Gram-negative microorganisms. The FDA has set an action date of February 23, 2027 under the Prescription Drug User Fee Act (PDUFA). The sNDA is supported by results from three clinical studies that investigated the safety, tolerability, pharmacokinetics and efficacy of cefiderocol in 154 children from birth (at least 26 weeks of gestational age) to less than 18 years of age, with cUTI, HABP/VABP and other infections caused by suspected or confirmed Gram-negative bacteria. 1,2,3 In 2023, cefiderocol was included in the World Health Organization’s PAediatric Drug Optimization (PADO) priority list, which identifies medicines most urgently needed for children, especially where there are gaps in dosing, safety data, or age‑appropriate formulations. 4 ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); The expansion of Fetroja for pediatric HABP/VABP is supported by an ongoing contract with the U.S. Government through the Biomedical Advanced Research and Development Authority’s (BARDA) Project BioShield . This project has been funded with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50126C00004. Fetroja is approved in the U.S. for the treatment of adult patients with cUTIs, including pyelonephritis and HABP/VABP caused by certain susceptible Gram-negative bacterial infections. 5 For full Prescribing Information for Fetroja, including approved indications and Safety Information, please visit . About Shionogi in Infectious Disease Over the past 70 years, Shionogi has discovered and commercialized six novel antibiotics. Today, our R&D story extends beyond antibiotics to include novel medications for HIV and influenza. Our global pipeline includes investigational agents to address global health challenges including antimicrobial resistance, COVID-19, influenza, rare fungal diseases and respiratory syncytial virus. As part of our commitment to addressing unmet medical needs, Shionogi partners with several non-governmental organizations to increase equitable access to our medications worldwide. Shionogi and Global Antibiotic Research and Development Partnership (GARDP) have a license agreement and Shionogi and GARDP have a collaboration agreement with the Clinton Health Access Initiative (CHAI) that aim to transform the landscape of access to antibiotics in most low-, lower middle- and upper middle-income countries, and select high-income countries. Shionogi ranked second among large research-based pharmaceutical companies in the Access to Medicine Foundation’s 2026 Antimicrobial Resistance (AMR) Benchmark , a global assessment of how leading pharmaceutical companies are tackling antimicrobial resistance and expanding responsible access to antibiotics worldwide. About Shionogi Inc. Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a global research‑driven pharmaceutical company committed to bringing to market the best possible medicines to aid the health and well-being of the patients we serve. Our global expertise in infectious disease began in the 1950s and in addition to discovering and developing multiple innovative antibiotics, today our global portfolio includes an antibiotic for the treatment of serious Gram‑negative bacterial infections, antivirals for COVID-19, HIV and influenza and a therapeutic for rare fungal infections. Our U.S. infectious disease franchise includes both approved and investigational novel anti-infectives, and investigational antivirals for COVID-19 and RSV. In parallel, we are advancing a U.S. rare disease franchise that includes an approved therapy for amyotrophic lateral sclerosis (ALS), along with clinical programs in Fragile X syndrome, Jordan’s syndrome, and Pompe disease. We are also pursuing research in additional high‑unmet need therapeutic areas, including oncology, acute ischemic stroke, sleep apnea, and other quality of life areas. Learn more at shionogi.com . About Shionogi & Co., Ltd. Shionogi & Co., Ltd. is a 148-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain, and CNS disorders. Shionogi’s research and development currently targets two therapeutic areas: infectious diseases and diseases with unmet medical needs in pain/CNS, including Alzheimer’s disease, oncology, rare diseases, and sleep apnea. For more information on Shionogi & Co., Ltd., please visit . 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. ____________________ 1 Clinical Trials.gov [Internet]. A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants. Available from: 2 Clinical Trials.gov [Internet]. A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Cefiderocol in Hospitalized Pediatric Participants. Available from: 3 Clinical Trials.gov [Internet]. A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Neonates and Infants. Available from: 4 World Health Organization [Internet]. Towards investigation, development and introduction of cefiderocol in children: product brief. Available from: 5 Fetroja Prescribing information. Available from: . Accessed June 2026. Contacts Media Contacts: U.S.: ShionogiCommunications@shionogi.com Japan: Europe: pressoffice@shionogi.eu

16 Jul 2026

·allsci.com

Shionogi seeking to expand Fetroja use into pediatric settings

Japan-based Shionogi & Co., Ltd. said the US FDA has accepted a Supplemental New Drug Application (sNDA) for cefiderocol (Fetroja), seeking to extend the antibiotic’s use to pediatric patients as young as 26 weeks of gestational age with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) and complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative organisms. The filing, submitted by the New Jersey arm of Shionogi, moves the Fetroja pediatric FDA approval process into formal review, with the FDA setting a PDUFA action date of February 23, 2027. Fetroja is currently approved in the US only for adults with these infections; the sNDA, if cleared, would make it one of the few novel antibiotics with a labeled indication for pediatric HABP/VABP. The filing addresses a gap that has persisted since cefiderocol’s 2019 approval. Companies developing antibiotics for multidrug-resistant Gram-negative bacterial infections treatment have historically prioritized adult registration trials, leaving clinicians to use these agents off-label in children based on extrapolated dosing. The World Health Organization flagged this gap explicitly, adding cefiderocol to its 2023 PAediatric Drug Optimization priority list, which identifies medicines urgently needed for children where dosing, safety, and formulation data are lacking. Pediatric serious infections caused by drug-resistant Gram-negative bacteria, including carbapenem-resistant Enterobacterales, Acinetobacter baumannii, and Pseudomonas aeruginosa, present a narrower set of treatment options than in adults. Several newer beta-lactam/beta-lactamase inhibitor combinations, including ceftazidime-avibactam and ceftolozane-tazobactam, hold pediatric approvals for cUTI and complicated intra-abdominal infections but not for HABP/VABP. Others, such as imipenem-cilastatin-relebactam and meropenem-vaborbactam, remain restricted to adults across all indications. If the sNDA is cleared, cefiderocol would become one of the only novel antibiotics with a dedicated pediatric label covering hospital-acquired and ventilator-associated pneumonia, a niche where clinicians currently rely on carbapenems or off-label use of newer agents. Shionogi’s pursuit of this indication is also tied to broader government-backed antimicrobial resistance efforts. The expansion work is supported by an existing contract with the Biomedical Advanced Research and Development Authority (BARDA) under Project BioShield, a program initially funded at $119 million with multiyear options worth up to $482 million. That contract also funds a US manufacturing site for Fetroja and work extending the antibiotic against biothreat pathogens including Burkholderia pseudomallei and Yersinia pestis, indicating the pediatric filing sits within a wider federal push to secure domestic supply of drugs effective against resistant and biothreat organisms. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

Drug ApprovalQualified Infectious Disease Product

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
Complicated urinary tract infection	South Korea	Jeil Pharmaceutical Co., Ltd.	18 Feb 2025
Infectious Diseases	Japan	Shionogi Pharma, Inc.	30 Nov 2023
Hospital-acquired pneumonia	United States	Shionogi, Inc.	25 Sep 2020
Hospital-acquired pneumonia	United States	Shionogi & Co., Ltd.	25 Sep 2020
Klebsiella Infections	United States	Shionogi, Inc.	25 Sep 2020
Klebsiella Infections	United States	Shionogi & Co., Ltd.	25 Sep 2020
Pneumonia, Ventilator-Associated	United States	Shionogi & Co., Ltd.	25 Sep 2020
Pneumonia, Ventilator-Associated	United States	Shionogi, Inc.	25 Sep 2020
Serratia Infections	United States	Shionogi & Co., Ltd.	25 Sep 2020
Serratia Infections	United States	Shionogi, Inc.	25 Sep 2020
Gram-Negative Bacterial Infections	European Union	Qualicaps Netherlands BV	23 Apr 2020
Gram-Negative Bacterial Infections	Iceland	Qualicaps Netherlands BV	23 Apr 2020
Gram-Negative Bacterial Infections	Liechtenstein	Qualicaps Netherlands BV	23 Apr 2020
Gram-Negative Bacterial Infections	Norway	Qualicaps Netherlands BV	23 Apr 2020
Pyelonephritis	United States	Shionogi & Co., Ltd.	14 Nov 2019
Pyelonephritis	United States	Shionogi, Inc.	14 Nov 2019
Urinary Tract Infections	United States	Shionogi, Inc.	14 Nov 2019
Urinary Tract Infections	United States	Shionogi & Co., Ltd.	14 Nov 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Complicated intra-abdominal infection	Phase 3	China	Ping An Shionogi Co., Ltd.	21 Nov 2022
Carbapenem Resistant Bacterial Infection	Phase 3	China	Ping An Shionogi Co., Ltd.	16 Sep 2022
Hospital acquired bacterial pneumonia	Phase 3	United States	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Japan	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Belgium	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Canada	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Czechia	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Estonia	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	France	Shionogi, Inc.	24 Oct 2017
Hospital acquired bacterial pneumonia	Phase 3	Germany	Shionogi, Inc.	24 Oct 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04335539 (PEDI-CEFI, CTgov)	Phase 2	Gram-Negative Bacterial Infections \| Complicated intra-abdominal infection \| Pneumonia, Ventilator-Associated ... View more	53	cefiderocol (Single-Dose Phase: Cohort 1 (12 to <18 Years))	xlqsmnvfmr = uoilymcbsa vchbboguek (ggyqwjqdyk, snhuwqyvrg - xgvkktmufy) View more	-	27 Feb 2026
				cefiderocol (Single-Dose Phase: Cohort 2 (6 to <12 Years))	xlqsmnvfmr = ouneahemai vchbboguek (ggyqwjqdyk, cfzysyomrr - fwlpahslrn) View more
NCT05789199 (PERSEUS study, Pubmed \| Eur J Clin Microbiol Infect Dis)	Not Applicable	Gram-Negative Bacterial Infections	261	Cefiderocol	luoipxahvu(ilcpniszqj) = arfbfkefjn gcyvezcali (tnotkwodiz ) View more	Positive	25 Mar 2025
NCT05789199 (PERSEUS study, Pubmed \| Eur J Clin Microbiol Infect Dis)	Not Applicable	Chronic Kidney Diseases Gram-negative bacteria	-	Cefiderocol (Stenotrophomonas maltophilia)	inaumotpal(cznlkwewjt) = wkcdnadaxg yftibzanbz (cxncevfzyd )	Positive	24 Mar 2025
				Cefiderocol (Burkholderia cepacia complex)	inaumotpal(cznlkwewjt) = yxznfrwkdx yftibzanbz (cxncevfzyd )
NCT05395104 (CTgov)	Phase 1	-	14	Cefiderocol+Midazolam	sbkgpycyoc(olbczplavi) = veyzjjbjtd sqmyqfhkex (yoqqqkvyls, 45.3) View more	-	14 Dec 2023
NCT03032380 (APEKS-NP, Pubmed \| Eur J Clin Microbiol) Manual	Phase 3	Healthcare-Associated Pneumonia	-	Linezolid+Cefiderocol	dopaylpztv(usheysmvao) = hgtiuqzhdx ghfzysnxxw (ssbxkaoqad ) View more	Non-inferior	13 Jan 2022
				Linezolid+meropenem	dopaylpztv(usheysmvao) = mgnitkwcze ghfzysnxxw (ssbxkaoqad ) View more
NCT02714595 (CREDIBLE-CR, Pubmed \| Lancet Infect Dis) Manual	Phase 3	Infectious Diseases	152	cefiderocol	ggoshwrqtz(cuelmyqkwv) = jahfcfjolp mjurczmbnz (gryeiluusd, 23.2 - 65.5) View more	Similar	01 Feb 2021
				best available therapy	ggoshwrqtz(cuelmyqkwv) = zkzqrydsvj mjurczmbnz (gryeiluusd, 17.7 - 71.1) View more
NCT02321800 (APEKS-cUTI, Pubmed)	Phase 2	Complicated lower urinary tract infection	371	Cefiderocol	zmdofnegnv(xpdgdwiolo) = vcbiufmiay uxsbjqbdxg (omkwhrfcyg )	-	01 Jan 2021
				Imipenem-cilastatin	zmdofnegnv(xpdgdwiolo) = hiuybusqkd uxsbjqbdxg (omkwhrfcyg )
NCT03032380 (APEKS-NP, CTgov)	Phase 3	Hospital acquired bacterial pneumonia \| Ventilator associated bacterial pneumonia	300	Cefiderocol+Linezolid (Cefiderocol)	rmixnpzfkl = wwxbgtzdmj jalfrnzjpl (xnbyzxuwfd, kafmbbspfn - otrgclyyky) View more	-	13 Nov 2020
				Meropenem+Linezolid (Meropenem)	rmixnpzfkl = ektzcswddb jalfrnzjpl (xnbyzxuwfd, zaeaupener - qzpchgevjh) View more
NCT03862040 (CTgov)	Phase 1	Pneumonia, Bacterial	7	Standard of Care Antibiotic+Cefiderocol	aquihwamyt(tgjfiuands) = dgqigiofjf zybxgqozjf (zjxdxwuwas, ovboatodhf - qbtzuqaypf) View more	-	05 Nov 2020
NCT02321800 (Pubmed) Manual	Phase 2	Urinary Tract Infections Gram-negative	452	Cefiderocol	hwgnkxckhl(nlthetpomw) = epybnbqzxe hjwdabears (ysesjixfqk ) View more	Positive	01 Dec 2018
				imipenem-cilastatin	hwgnkxckhl(nlthetpomw) = xlolknbrlx hjwdabears (ysesjixfqk ) View more

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