ReviewClinical infectious diseases : an official publication of the Infectious Diseases Society of America2019
Pathogen-focused Clinical Development to Address Unmet Medical Need: Cefiderocol Targeting Carbapenem Resistance.
Review in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.
- Drug-resistantClinical microbiology reviews · 2025Pooled it
- Article
- Siderophore cephalosporins.EcoSal Plus · 2025Review
- Mechanisms, therapeutic strategies, and emerging therapeutic alternatives for carbapenem resistance in Gram-negative bacteria.Archives of microbiology · 2025Review
- Updates on the Activity, Efficacy and Emerging Mechanisms of Resistance to Cefiderocol.Current issues in molecular biology · 2024Review
- Article
- Deciphering the relative importance of genetic elements in hypervirulent Klebsiella pneumoniae to guide countermeasure development.EBioMedicine · 2024Article
- Leaks in the Pipeline: a Failure Analysis of Gram-Negative Antibiotic Development from 2010 to 2020.Antimicrobial agents and chemotherapy · 2022Review
- Cefiderocol: A New Cephalosporin Stratagem Against Multidrug-Resistant Gram-Negative Bacteria.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022Review
- Article
- Translation of Pharmacodynamic Biomarkers of Antibiotic Efficacy in Specific Populations to Optimize Doses.Antibiotics (Basel, Switzerland) · 2021Review
- Is it time to move away from polymyxins?: evidence and alternatives.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2021Review
- Novel Cephalosporins in Septic Subjects and Severe Infections: Present Findings and Future Perspective.Frontiers in medicine · 2021Article
- Needs assessment for novel Gram-negative antibiotics in US hospitals: a retrospective cohort study.The Lancet. Infectious diseases · 2020Article
- Critical analysis of antibacterial agents in clinical development.Nature reviews. Microbiology · 2020Review
- Evaluating Cefiderocol in the Treatment of Multidrug-Resistant Gram-Negative Bacilli: A Review of the Emerging Data.Infection and drug resistance · 2020Review
- Cefiderocol: Discovery, Chemistry, and In Vivo Profiles of a Novel Siderophore Cephalosporin.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Review
- Pharmacokinetic and Pharmacodynamic Profiles of Cefiderocol, a Novel Siderophore Cephalosporin.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Review
- Cefiderocol: A Novel Siderophore Cephalosporin Defeating Carbapenem-resistant Pathogens.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Historically, the regulatory requirements of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for developing new antibiotics have not addressed pathogen-focused indications for drug approval. The design of the necessary randomized controlled trials traditionally involves the enrollment of patients with site-specific infections caused by susceptible as well as resistant pathogens. Cefiderocol has undergone a streamlined clinical development program to address serious carbapenem-resistant infections. The regulatory approach, and the pivotal clinical trials, differed between the FDA and EMA. In the United States, the APEKS-cUTI (Acinetobacter, Pseudomonas, Escherichia coli, Klebsiella, Stenotrophomonas-complicated urinary tract infection) study was conducted to provide the basis for FDA approval of a site-specific cUTI indication. The EMA, however, preferred the CREDIBLE-CR (A MultiCenter, RandomizED, Open-label ClInical Study of S-649266 or Best AvailabLE Therapy for the Treatment of Severe Infections Caused by Carbapenem-Resistant Gram-negative Pathogens) study, in which patients with nosocomial pneumonia, bloodstream infections, or cUTIs were enrolled if they had a carbapenem-resistant pathogen. The resulting European label will be pathogen focused rather than infection site specific (ie, treatment of gram-negative infection in patients with limited treatment options). The implications and limitations of these different regulatory processes are discussed.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.