Trial reportIntensive care medicine2012
BAY41-6551 achieves bactericidal tracheal aspirate amikacin concentrations in mechanically ventilated patients with Gram-negative pneumonia.
Trial report in Intensive care medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01004445 (A Double-Blind, Placebo-controlled Parallel Group, Phase II Dose-Ranging Study of Nebulized Amikacin Delivered Via the Pulmonary Drug Delivery System), which is not on this map. Cited by 53 papers, 8 of them syntheses that pooled it.
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.
A Double-Blind, Placebo-controlled Parallel Group, Phase II Dose-Ranging Study of Nebulized Amikacin Delivered Via the Pulmonary Drug Delivery System (PDDS) in Ventilated Patients With Nosocomial Pneumonia Due to Gram Negative Organisms
Who cites it
53 citing papers in PubMed, 8 syntheses or guidelines pooled it, 171 citations in OpenAlex.
- Inhaled antibiotics for treating pneumonia in invasively ventilated patients in intensive care unit: a meta-analysis of randomized clinical trials with trial sequential analysis.Critical care (London, England) · 2024Pooled it
- Amikacin nebulization for the adjunctive therapy of gram-negative pneumonia in mechanically ventilated patients: a systematic review and meta-analysis of randomized controlled trials.Scientific reports · 2021Pooled it
- Antimicrobials for the treatment of drug-resistant Acinetobacter baumannii pneumonia in critically ill patients: a systemic review and Bayesian network meta-analysis.Critical care (London, England) · 2017Pooled it
- Aerosol delivery during invasive mechanical ventilation: a systematic review.Critical care (London, England) · 2017Pooled it
- The use of inhaled antibiotic therapy in the treatment of ventilator-associated pneumonia and tracheobronchitis: a systematic review.BMC pulmonary medicine · 2016Pooled it
- Task force on management and prevention of Acinetobacter baumannii infections in the ICU.Intensive care medicine · 2015Guideline
- Short-course versus prolonged-course antibiotic therapy for hospital-acquired pneumonia in critically ill adults.The Cochrane database of systematic reviews · 2015Pooled it
- Nebulized antibiotics for ventilator-associated pneumonia: a systematic review and meta-analysis.Critical care (London, England) · 2015Pooled it
- Amikacin pharmacokinetics after nebulization among intubated patients.Critical care (London, England) · 2026Trial
- SPECT-CT Comparison of Lung Deposition using a System combining a Vibrating-mesh Nebulizer with a Valved Holding Chamber and a Conventional Jet Nebulizer: a Randomized Cross-over Study.Pharmaceutical research · 2017Trial
- A randomized double-blind placebo-controlled dose-escalation phase 1 study of aerosolized amikacin and fosfomycin delivered via the PARI investigational eFlow® inline nebulizer system in mechanically ventilated patients.Journal of aerosol medicine and pulmonary drug delivery · 2014Trial
- Use of mucolytics and inhaled antibiotics in the NICU.Journal of perinatology : official journal of the California Perinatal Association · 2025Review
- Prevention of ventilator-associated pneumonia with inhaled antibiotics.World journal of emergency medicine · 2024Article
- Inhaled drug delivery: a randomized study in intubated patients with healthy lungs.Annals of intensive care · 2023Article
- Article
- Inhaled amikacin for pneumonia treatment and dissemination prevention: an experimental model of severe monolateral Pseudomonas aeruginosa pneumonia.Critical care (London, England) · 2023Article
- How to Use Nebulized Antibiotics in Severe Respiratory Infections.Antibiotics (Basel, Switzerland) · 2023Review
- The Unfulfilled Promise of Inhaled Therapy in Ventilator-Associated Infections: Where Do We Go from Here?Journal of aerosol medicine and pulmonary drug delivery · 2022Review
- Aerosolized antibiotics in the treatment of hospital-acquired pneumonia/ventilator-associated pneumonia.The Korean journal of internal medicine · 2022Review
- Liposomal drug delivery to manage nontuberculous mycobacterial pulmonary disease and other chronic lung infections.European respiratory review : an official journal of the European Respiratory Society · 2021Review
Corrections and comments
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Authors and funding
6 authors at 6 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo conduct a multicenter, randomized, placebo-controlled, double-blind, phase II study of BAY41-6551 (NCT01004445), an investigational drug-device combination of amikacin, formulated for inhalation, and a proprietary Pulmonary Drug Delivery System, for the treatment of Gram-negative pneumonia in mechanically ventilated patients.
methodsSixty-nine mechanically ventilated patients with Gram-negative pneumonia, a clinical pulmonary infection score ≥6, at risk for multidrug-resistant organisms, were randomized to BAY41-6551 400 mg every 12 h (q12h), 400 mg every 24 h (q24h) with aerosol placebo, or placebo q12h for 7-14 days, plus standard intravenous antibiotics. The combined primary endpoint was a tracheal aspirate amikacin maximum concentration ≥6,400 μg/mL (25 × 256 μg/mL reference minimum inhibitory concentration) and a ratio of area under the aspirate concentration-time curve (0-24 h) to minimum inhibitory concentration ≥100 on day 1.
resultsThe primary endpoint was achieved in 50% (6/12) and 16.7% (3/18) of patients in the q12h and q24h groups, respectively. Clinical cure rates, in the 48 patients getting ≥7 days of therapy, were 93.8% (15/16), 75.0% (12/16), and 87.5% (14/16) in the q12h, q24h, and placebo groups, respectively (p = 0.467). By the end of aerosol therapy, the mean number of antibiotics per patient per day was 0.9 in the q12h, 1.3 in the q24h, and 1.9 in the placebo groups, respectively (p = 0.02 for difference between groups). BAY41-6551 was well tolerated and attributed to two adverse events in one patient (mild bronchospasm).
conclusionsBAY41-6551 400 mg q12h warrants further clinical evaluation.
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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.