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Intensive care medicine · Jul 2022
Randomized Controlled Trial Multicenter StudyComparison of 8 versus 15 days of antibiotic therapy for Pseudomonas aeruginosa ventilator-associated pneumonia in adults: a randomized, controlled, open-label trial.
- Adrien Bouglé, Sophie Tuffet, Laura Federici, Marc Leone, Antoine Monsel, Thomas Dessalle, Julien Amour, Claire Dahyot-Fizelier, François Barbier, Charles-Edouard Luyt, Olivier Langeron, Bernard Cholley, Julien Pottecher, Tarik Hissem, Jean-Yves Lefrant, Benoit Veber, Matthieu Legrand, Alexandre Demoule, Pierre Kalfon, Jean-Michel Constantin, Alexandra Rousseau, Tabassome Simon, Arnaud Foucrier, and iDIAPASON Trial Investigators.
- Department of Anesthesiology and Critical Care Medicine, Cardiology Institute, Sorbonne University, GRC 29, AP-HP, Pitié-Salpêtrière Hospital, 47-83 Boulevard de l'Hôpital, 75013, Paris, France. adrien.bougle@aphp.fr.
- Intensive Care Med. 2022 Jul 1; 48 (7): 841849841-849.
PurposeDuration of antibiotic therapy for ventilator-associated pneumonia (VAP) due to non-fermenting Gram-negative bacilli (NF-GNB), including Pseudomonas aeruginosa (PA) remains uncertain. We aimed to assess the non-inferiority of a short duration of antibiotics (8 days) vs. prolonged antibiotic therapy (15 days) in VAP due to PA (PA-VAP).MethodsWe conducted a nationwide, randomized, open-labeled, multicenter, non-inferiority trial to evaluate optimal duration of antibiotic treatment in PA-VAP. Eligible patients were adults with diagnosis of PA-VAP and randomly assigned in 1:1 ratio to receive a short-duration treatment (8 days) or a long-duration treatment (15 days). A pre-specified analysis was used to assess a composite endpoint combining mortality and PA-VAP recurrence rate during hospitalization in the intensive care unit (ICU) within 90 days.ResultsThe study was stopped after 24 months due to slow inclusion rate. In intention-to-treat population (n = 186), the percentage of patients who reached the composite endpoint was 25.5% (N = 25/98) in the 15-day group versus 35.2% (N = 31/88) in the 8-day group (difference 9.7%, 90% confidence interval (CI) -1.9%-21.2%). The percentage of recurrence of PA-VAP during the ICU stay was 9.2% in the 15-day group versus 17% in the 8-day group. The two groups had similar median days of mechanical ventilation, of ICU stay, number of extra pulmonary infections and acquisition of multidrug-resistant (MDR) pathogens during ICU stay.ConclusionsOur study failed to show the non-inferiority of a short duration of antibiotics in the treatment of PA-VAP, compared to a long duration. The short duration strategy may be associated to an increase of PA-VAP recurrence. However, the lack of power limits the interpretation of this study.© 2022. Springer-Verlag GmbH Germany, part of Springer Nature.
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