ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2018
Optimizing the Design and Analysis of Clinical Trials for Antibacterials Against Multidrug-resistant Organisms: A White Paper From COMBACTE's STAT-Net.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
What it found
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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
14 citing papers in PubMed.
- Win Ratio Analyses of Piperacillin-Tazobactam Versus Meropenem for Ceftriaxone-Nonsusceptible Escherichia coli or Klebsiella pneumoniae Bloodstream Infections: Post Hoc Insights From the MERINO Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Trial
- Evaluating the efficiency of platform trials relative to stand-alone trials: a simulation study for the evaluation of new antibacterials.The Journal of antimicrobial chemotherapy · 2026Article
- Reserve antibiotics: overcoming limitations of evidence generated from regulatory approval trials.Globalization and health · 2025Review
- Multistate modeling for survival analysis in critically ill patients treated with meropenem.CPT: pharmacometrics & systems pharmacology · 2024Article
- Treatment and diagnosis of severe KPC-producingAnnals of medicine · 2023Article
- Optimizing patient recruitment into clinical trials of antimicrobial-resistant pathogens.JAC-antimicrobial resistance · 2023Review
- Perpetual observational studies: new strategies to support efficient implementation of observational studies and randomized trials in infectious diseases.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2022Article
- Diagnostic Testing for Sepsis: A Systematic Review of Economic Evaluations.Antibiotics (Basel, Switzerland) · 2021Review
- Real-world, Multicenter Experience With Meropenem-Vaborbactam for Gram-Negative Bacterial Infections Including Carbapenem-ResistantOpen forum infectious diseases · 2021Article
- Ceftolozane/Tazobactam for Resistant DrugsLife (Basel, Switzerland) · 2021Review
- Prophage in Phage Manufacturing: Is the Risk Overrated Compared to Other Therapies or Food?Antibiotics (Basel, Switzerland) · 2020Article
- Considerations and Caveats in Combating ESKAPE Pathogens against Nosocomial Infections.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2020Review
- Prognostic Utility of the New Definition of Difficult-to-Treat Resistance Among Patients With Gram-Negative Bloodstream Infections.Open forum infectious diseases · 2019Article
- Elaboration of Consensus Clinical Endpoints to Evaluate Antimicrobial Treatment Efficacy in Future Hospital-acquired/Ventilator-associated Bacterial Pneumonia Clinical Trials.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Article
Corrections and comments
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Authors and funding
21 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Innovations are urgently required for clinical development of antibacterials against multidrug-resistant organisms. Therefore, a European, public-private working group (STAT-Net; part of Combatting Bacterial Resistance in Europe [COMBACTE]), has reviewed and tested several innovative trials designs and analytical methods for randomized clinical trials, which has resulted in 8 recommendations. The first 3 focus on pharmacokinetic and pharmacodynamic modeling, emphasizing the pertinence of population-based pharmacokinetic models, regulatory procedures for the reassessment of old antibiotics, and rigorous quality improvement. Recommendations 4 and 5 address the need for more sensitive primary end points through the use of rank-based or time-dependent composite end points. Recommendation 6 relates to the applicability of hierarchical nested-trial designs, and the last 2 recommendations propose the incorporation of historical or concomitant trial data through Bayesian methods and/or platform trials. Although not all of these recommendations are directly applicable, they provide a solid, evidence-based approach to develop new, and established, antibacterials and address this public health challenge.
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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.