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Randomized Controlled Trial
. 2022 Jul;48(7):841-849.
doi: 10.1007/s00134-022-06690-5. Epub 2022 May 13.

Comparison of 8 versus 15 days of antibiotic therapy for Pseudomonas aeruginosa ventilator-associated pneumonia in adults: a randomized, controlled, open-label trial

Adrien Bouglé  1 , Sophie Tuffet  2 , Laura Federici  3 , Marc Leone  4 , Antoine Monsel  5 , Thomas Dessalle  6 , Julien Amour  6 , Claire Dahyot-Fizelier  7 , François Barbier  8 , Charles-Edouard Luyt  9 , Olivier Langeron  5 , Bernard Cholley  10 , Julien Pottecher  11 , Tarik Hissem  12 , Jean-Yves Lefrant  13 , Benoit Veber  14 , Matthieu Legrand  15 , Alexandre Demoule  16 , Pierre Kalfon  17 , Jean-Michel Constantin  18 , Alexandra Rousseau  2 , Tabassome Simon  2 , Arnaud Foucrier  19 ; iDIAPASON Trial Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Comparison of 8 versus 15 days of antibiotic therapy for Pseudomonas aeruginosa ventilator-associated pneumonia in adults: a randomized, controlled, open-label trial

Adrien Bouglé et al. Intensive Care Med. 2022 Jul.

Erratum in

Abstract

Purpose: Duration 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).

Methods: We 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.

Results: The 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.

Conclusions: Our 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.

Keywords: Antibiotic therapy; Pseudomonas aeruginosa; Recurrence; Survival; Ventilator-associated pneumonia.

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References

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