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Antibiotic prophylaxis of early onset pneumonia in critically ill comatose patients. A randomized study.
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- Author(s): Acquarolo, A.; Urli, T.; Perone, G.; Giannotti, C.; Candiani, A.; Latronico, N.
- Source:
Intensive Care Medicine; Apr2005, Vol. 31 Issue 4, p510-516, 7p- Subject Terms:
PNEUMONIA; ANTIBIOTICS; PREVENTIVE medicine; CRITICALLY ill; LUNG diseases; CRITICAL care medicine; PNEUMONIA prevention; PENICILLIN; AMPICILLIN; ARTIFICIAL respiration; BRAIN injuries; CATASTROPHIC illness; CLINICAL trials; COMA; COMPARATIVE studies; DRUG resistance; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; RESEARCH; STATISTICAL sampling; EVALUATION research; RANDOMIZED controlled trials; ANTIBIOTIC prophylaxis; THERAPEUTICS - Source:
- Additional Information
- Subject Terms:
- Abstract:
Objective: To evaluate if a 3-day ampicillin-sulbactam prophylaxis can reduce the occurrence of early-onset pneumonia (EOP) in comatose mechanically-ventilated patients.Design: This was a single-centre, prospective, randomised, open study.Setting: A 10-bed general-neurological ICU in a 2,000-bed university hospital.Patients and Participants: Comatose mechanically-ventilated patients with traumatic, surgical or medical brain injury.Interventions: Patients were randomized to either ampicillin-sulbactam prophylaxis (3 g every 6 h for 3 days) plus standard treatment or standard treatment alone.Measurements and Results: Main outcome was the occurrence of EOP. Secondary outcome measures were occurrence of late-onset pneumonia, percentage of non-pulmonary infections and of emerging multiresistant bacteria, duration of mechanical ventilation and of ICU stay and ICU mortality. Interim analysis at 1 year demonstrated a statistically significant reduction of EOP in the ampicillin-sulbactam group, and the study was interrupted. Overall, 39.5% of the patients developed EOP, 57.9% in the standard treatment group and 21.0% in the ampicillin-sulbactam group (chi-square 5.3971; P =0.022). Relative risk reduction of EOP in patients receiving ampicillin-sulbactam prophylaxis was 64%; the number of patients to be treated to avoid one episode of EOP was three. No differences in other outcome parameters were found; however, the small sample size precluded a definite analysis.Conclusions: Antibiotic prophylaxis with ampicillin-sulbactam significantly reduced the occurrence of EOP in critically ill comatose mechanically ventilated patients. This result should encourage a large multicenter trial to demonstrate whether ampicillin-sulbactam prophylaxis reduces patient mortality, and whether antibiotic resistance is increased in patients receiving prophylaxis. [ABSTRACT FROM AUTHOR] - Abstract: Copyright of Intensive Care Medicine is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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