ArticleOpen forum infectious diseases2019
Randomized Trial of Ceftazidime-Avibactam vs Meropenem for Treatment of Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (REPROVE): Analyses per US FDA-Specified End Points.
Article in Open forum infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 2 of them syntheses that pooled it.
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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
29 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Efficacy of Ceftazidime-avibactam in treating Gram-negative infections: a systematic review and meta-analysis.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2025Pooled it
- Is Ceftazidime/Avibactam an Option for Serious Infections Due to Extended-Spectrum-β-Lactamase- and AmpC-ProducingAntimicrobial agents and chemotherapy · 2020Pooled it
- Pharmacokinetics and Safety of Ceftazidime-Avibactam in Neonates and Young Infants: A Phase 2a, Multicenter Prospective Trial.Journal of the Pediatric Infectious Diseases Society · 2025Trial
- Population Pharmacokinetic Modeling and Probability of Pharmacodynamic Target Attainment for Ceftazidime-Avibactam in Pediatric Patients Aged 3 Months and Older.Clinical pharmacology and therapeutics · 2022Trial
- Trial
- Population Pharmacokinetic Modelling of Ceftazidime and Avibactam in the Plasma and Epithelial Lining Fluid of Healthy Volunteers.Drugs in R&D · 2018Trial
- Real-World Effectiveness of Ceftazidime-Avibactam for Multidrug-Resistant Gram-Negative Pneumonia, Time-Stratified Risk Factors for Short- and Long-Term Mortality, and Inpatient Costs: A Multicenter Retrospective Cohort Study.Infectious diseases and therapy · 2026Article
- Ceftazidime/Avibactam Monotherapy Versus Other Antibiotics: Where Do We Stand?Pathogens (Basel, Switzerland) · 2025Review
- Carbapenem-ResistantMicroorganisms · 2025Review
- Clinical efficacy, safety and pharmacokinetics of novel β-lactam/β-lactamase inhibitor combinations: a systematic review.JAC-antimicrobial resistance · 2025Review
- Article
- Novel Siderophore Cephalosporin and Combinations of Cephalosporins with β-Lactamase Inhibitors as an Advancement in Treatment of Ventilator-Associated Pneumonia.Antibiotics (Basel, Switzerland) · 2024Review
- Effectiveness of Ceftazidime-Avibactam in Gram-Negative Nosocomial Pneumonia: A Real-World Study in India.Cureus · 2024Article
- Weighing the Odds: Novel β-Lactam/β-Lactamase Inhibitor Use in Hospital-Acquired and Ventilator-AssociatedOpen forum infectious diseases · 2023Article
- The place of new antibiotics for Gram-negative bacterial infections in intensive care: report of a consensus conference.Annals of intensive care · 2023Review
- [Clinical experience using cefiderocol].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2023Review
- Carbapenem-ResistantAntibiotics (Basel, Switzerland) · 2023Review
- Multi-drug resistant gram-negative bacterial pneumonia: etiology, risk factors, and drug resistance patterns.Pneumonia (Nathan Qld.) · 2022Review
- Microbiological, Clinical, and PK/PD Features of the New Anti-Gram-Negative Antibiotics: β-Lactam/β-Lactamase Inhibitors in Combination and Cefiderocol-An All-Inclusive Guide for Clinicians.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Advances in novel antibiotics to treat multidrug-resistant gram-negative bacterial infections.Internal and emergency medicine · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHospital-acquired and ventilator-associated pneumonia (HAP/VAP; nosocomial pneumonia) due to Gram-negative pathogens are associated with significant morbidity and mortality; treatment options for multidrug-resistant infections are limited. The pivotal phase III REPROVE trial evaluated the efficacy of ceftazidime-avibactam (CAZ-AVI) vs meropenem in the treatment of patients with HAP/VAP. Study results for prespecified analyses per US Food and Drug Administration-recommended trial end points are reported here.
methodsHospitalized adults with HAP/VAP proven or suspected to be caused by a Gram-negative pathogen were randomized 1:1 to receive CAZ-AVI or meropenem for 7 to 14 days. The primary outcome was 28-day all-cause mortality in the intent-to-treat (ITT) population. Secondary outcomes included clinical cure at test of cure (TOC) in the ITT and microbiological ITT (micro-ITT) populations, and safety and tolerability throughout the study.
resultshundred seventy randomized patients received treatment and were included in the ITT population (CAZ-AVI, n = 436; meropenem, n = 434). CAZ-AVI was noninferior to meropenem for the primary end point (28-day all-cause mortality; ITT) based on the prespecified 10% noninferiority margin (CAZ-AVI, 9.6%; meropenem, 8.3%; difference, 1.5%; 95% confidence interval [CI], -2.4% to 5.3%) and for the clinical cure end point in the ITT population based on a prespecified -10% noninferiority margin (CAZ-AVI, 67.2%; meropenem, 69.1%; difference, -1.9%; 95% CI, -8.1% to 4.3%). Clinical cure rates at TOC for patients infected with CAZ-nonsusceptible pathogens were similar (CAZ-AVI, 75.5%; meropenem, 71.2%; micro-ITT). Safety data were consistent with established safety profiles for both agents.
conclusionsCAZ-AVI provides an important new treatment option for HAP/VAP due to Gram-negative pathogens, including CAZ-nonsusceptible strains.
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