• A Acquarolo, T Urli, G Perone, C Giannotti, A Candiani, and N Latronico.
• Institute of Anesthesiology-Intensive Care, University of Brescia Spedali Civili, Piazzale Ospedali Civili 1, 25125 Brescia, Italy. a.acquarolo@tiscali.it
• Intensive Care Med. 2005 Apr 1;31(4):510-6.

ObjectiveTo evaluate if a 3-day ampicillin-sulbactam prophylaxis can reduce the occurrence of early-onset pneumonia (EOP) in comatose mechanically-ventilated patients.DesignThis was a single-centre, prospective, randomised, open study.SettingA 10-bed general-neurological ICU in a 2,000-bed university hospital.Patients And ParticipantsComatose mechanically-ventilated patients with traumatic, surgical or medical brain injury.InterventionsPatients were randomized to either ampicillin-sulbactam prophylaxis (3 g every 6 h for 3 days) plus standard treatment or standard treatment alone.Measurements And ResultsMain 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.ConclusionsAntibiotic 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.

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