ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2019
Elaboration of Consensus Clinical Endpoints to Evaluate Antimicrobial Treatment Efficacy in Future Hospital-acquired/Ventilator-associated Bacterial Pneumonia Clinical Trials.
Article 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 27 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
27 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and safety of nebulized drugs in the treatment of non-severeFrontiers in pharmacology · 2025Pooled it
- 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
- Outcomes in participants with failure of initial antibacterial therapy for hospital-acquired/ventilator-associated bacterial pneumonia prior to enrollment in the randomized, controlled phase 3 ASPECT-NP trial of ceftolozane/tazobactam versus meropenem.Critical care (London, England) · 2022Trial
- Intrapulmonary concentrations of meropenem administered by continuous infusion in critically ill patients with nosocomial pneumonia: a randomized pharmacokinetic trial.Critical care (London, England) · 2020Trial
- Identification of a robust metabolic signature associated with hospital-acquired pneumonia and response to interferon-gamma treatment in critically ill patients.Critical care (London, England) · 2026Observational
- Perpetual observational study of the clinical and microbiological epidemiology of ventilator-associated pneumonia in Europe.Critical care (London, England) · 2026Observational
- Association of Arterial PaCODiagnostics (Basel, Switzerland) · 2026Article
- Can Model-Informed Precision Dosing of Beta-Lactams in Critical Care Improve Clinical Outcomes?Chemotherapy · 2026Review
- Predictors of clinical outcomes in Chinese patients with carbapenem-resistant Gram-negative bacterial infections receiving colistimethate sodium: a retrospective cohort study.Frontiers in cellular and infection microbiology · 2026Article
- Impact of respiratory viruses detection on outcomes in ventilated nosocomial pneumonia: an exposed/unexposed study.Annals of intensive care · 2025Article
- RAPID-CARE: Rapid Antibiotic Optimization in the ICU After Implementation of a Pneumonia Multiplex PCR Test-A Real-World Evaluation.Antibiotics (Basel, Switzerland) · 2025Article
- Ventilator-associated pneumonia biomarker evaluation (VIBE) study: protocol for a prospective, observational, case-cohort study.BMJ open · 2025Article
- Assessing FilmArray Pneumonia+ panel dynamics during antibiotic treatment to predict clinical success in ICU patients with ventilated hospital-acquired pneumonia and ventilator-associated pneumonia: a multicenter prospective study.Critical care (London, England) · 2025Observational
- Ceftazidime-avibactam plus aztreonam cocktail for the treatment of VIM-producing Pseudomonas aeruginosa infections: good enough to have another?The Journal of antimicrobial chemotherapy · 2025Observational
- A consensus of European experts on the definition of ventilator-associated pneumonia recurrences obtained by the Delphi method: the RECUVAP study.Intensive care medicine · 2025Article
- The future roles and functions of Amiralmomenin Hospital of Islamic Azad University: Stakeholders viewpoints.Journal of education and health promotion · 2025Article
- Exploration of a Potential DOOR Endpoint for Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia Using Six Registrational Trials for Antibacterial Drugs.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Article
- Article
- Single-drug versus combination antimicrobial therapy in critically ill patients with hospital-acquired pneumonia and ventilator-associated pneumonia due to Gram-negative pathogens: a multicenter retrospective cohort study.Critical care (London, England) · 2024Article
- Article
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Authors and funding
29 authors.
Funding
Abstract
backgroundRandomized clinical trials (RCTs) in hospital-acquired and ventilator-associated bacterial pneumonia (HABP and VABP, respectively) are important for the evaluation of new antimicrobials. However, the heterogeneity in endpoints used in RCTs evaluating treatment of HABP/VABP may puzzle clinicians. The aim of this work was to reach a consensus on clinical endpoints to consider in future clinical trials evaluating antimicrobial treatment efficacy for HABP/VABP.
methodsTwenty-six international experts from intensive care, infectious diseases, and the pharmaceutical industry were polled using the Delphi method.
resultsThe panel recommended a hierarchical composite endpoint including, by priority order, (1) survival at day 28, (2) mechanical ventilation-free days through day 28, and (3) clinical cure between study days 7 and 10 for VABP; and (1) survival (day 28) and (2) clinical cure (days 7-10) for HABP. Clinical cure was defined as the combination of resolution of signs and symptoms present at enrollment and improvement or lack of progression of radiological signs. More than 70% of the experts agreed to assess survival and mechanical ventilation-free days though day 28, and clinical cure between day 7 and day 10 after treatment initiation. Finally, the hierarchical order of endpoint components was reached after 3 Delphi rounds (72% agreement).
conclusionsWe provide a multinational expert consensus on separate hierarchical composite endpoints for VABP and HABP, and on a definition of clinical cure that could be considered for use in future HABP/VABP clinical trials.
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