PneumA
Trial question
What is the role of 8 days of antibiotic therapy in adults with ventilator-associated pneumonia ?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 401
401 patients (112 female, 289 male).
Inclusion criteria: patients with ventilator-associated pneumonia by quantitative culture results of bronchoscopic specimens and who had received initial appropriate empirical antimicrobial therapy.
Key exclusion criteria: pregnancy, little chance of survival, neutropenia, concomitant stage 3 AIDS, or immunosuppression or long-term corticosteroid therapy.
Interventions
N=197 antibiotic treatment for 8 days (8 days of antibiotic therapy).
N=204 antibiotic treatment for 15 days (15 days of antibiotic therapy).
Primary outcome
Death at 28 days
18.8%
17.2%
18.8 %
14.1 %
9.4 %
4.7 %
0.0 %
Antibiotic treatment for 8
days
Antibiotic treatment for 15
days
No significant
difference ↔
No significant difference in death at 28 days (18.8% vs. 17.2%; ARD 1.6, 90% CI -3.7 to 6.9).
Secondary outcomes
No significant difference in recurrent infections (28.9% vs. 26%; difference 2.9, 90% CI -3.2 to 9.1).
Significant increase in mean (SD) antibiotic-free days (13.1 days vs. 8.7 days; MD 4.4, 95% CI 3.1 to 5.6).
Significant increase in recurrent pulmonary infection (40.6% vs. 25.4%; MD 15.2, 90% CI 0.04 to 0.27).
Conclusion
In patients with ventilator-associated pneumonia by quantitative culture results of bronchoscopic specimens and who had received initial appropriate empirical antimicrobial therapy, antibiotic treatment for 8 days were not superior to antibiotic treatment for 15 days with respect to death at 28 days.
Reference
Chastre J, Wolff M, Fagon JY et al. Comparison of 8 vs 15 days of antibiotic therapy for ventilator-associated pneumonia in adults: a randomized trial. JAMA. 2003 Nov 19;290(19):2588-98.
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