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Randomized Controlled Trial
. 2012;7(8):e41290.
doi: 10.1371/journal.pone.0041290. Epub 2012 Aug 31.

Early-onset ventilator-associated pneumonia in adults randomized clinical trial: comparison of 8 versus 15 days of antibiotic treatment

Gilles Capellier  1 , Hélène Mockly, Claire Charpentier, Djillali Annane, Gilles Blasco, Thibault Desmettre, Antoine Roch, Christophe Faisy, Joel Cousson, Samuel Limat, Mariette Mercier, Laurent Papazian
Affiliations
Randomized Controlled Trial

Early-onset ventilator-associated pneumonia in adults randomized clinical trial: comparison of 8 versus 15 days of antibiotic treatment

Gilles Capellier et al. PLoS One. 2012.

Abstract

Purpose: The optimal treatment duration for ventilator-associated pneumonia is based on one study dealing with late-onset of the condition. Shortening the length of antibiotic treatment remains a major prevention factor for the emergence of multiresistant bacteria.

Objective: To demonstrate that 2 different antibiotic treatment durations (8 versus 15 days) are equivalent in terms of clinical cure for early-onset ventilator-associated pneumonia.

Methods: Randomized, prospective, open, multicenter trial carried out from 1998 to 2002.

Measurements: The primary endpoint was the clinical cure rate at day 21. The mortality rate was evaluated on days 21 and 90.

Results: 225 patients were included in 13 centers. 191 (84.9%) patients were cured: 92 out of 109 (84.4%) in the 15 day cohort and 99 out of 116 (85.3%) in the 8 day cohort (difference = 0.9%, odds ratio = 0.929). 95% two-sided confidence intervals for difference and odds ratio were [-8.4% to 10.3%] and [0.448 to 1.928] respectively. Taking into account the limits of equivalence (10% for difference and 2.25 for odds ratio), the objective of demonstrative equivalence between the 2 treatment durations was fulfilled. Although the rate of secondary infection was greater in the 8 day than the 15 day cohort, the number of days of antibiotic treatment remained lower in the 8 day cohort. There was no difference in mortality rate between the 2 groups on days 21 and 90.

Conclusion: Our results suggest that an 8-day course of antibiotic therapy is safe for early-onset ventilator-associated pneumonia in intubated patients.

Trial registration: ClinicalTrials.gov NCT01559753.

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Conflict of interest statement

Competing Interests: The authors have read the journal's policy and have the following conflicts: Glaxo and Beecham Laboratory were part funders of this study. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Figure 1
Figure 1. Design of the study governing inclusion of a new patient according to BAL bacteriological results and follow up criteria.
Figure 2
Figure 2. Data regarding number of patients included, treated according to protocol and followed up at 21 and 90 days.
See this image and copyright information in PMC

References

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