Antibiotic prophylaxis of early onset pneumonia in critically ill comatose patients. A randomized study.
OBJECTIVE
To evaluate if a 3-day ampicillin-sulbactam prophylaxis can reduce the occurrence of early-onset pneumonia (EOP) in comatose mechanically-ventilated patients.


METHODS
This was a single-centre, prospective, randomised, open study.


METHODS
A 10-bed general-neurological ICU in a 2,000-bed university hospital.


METHODS
Comatose mechanically-ventilated patients with traumatic, surgical or medical brain injury.


METHODS
Patients were randomized to either ampicillin-sulbactam prophylaxis (3 g every 6 h for 3 days) plus standard treatment or standard treatment alone.


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.
Acquarolo
A
A
Institute of Anesthesiology-Intensive Care, University of Brescia Spedali Civili, Piazzale Ospedali Civili 1, 25125 Brescia, Italy. a.acquarolo@tiscali.it
Urli
T
T
Perone
G
G
Giannotti
C
C
Candiani
A
A
Latronico
N
N
D000328:Adult; D000667:Ampicillin / Q000627:therapeutic use*; D019072:Antibiotic Prophylaxis; D001930:Brain Injuries; D015331:Cohort Studies; D003128:Coma; D016638:Critical Illness; D004351:Drug Resistance; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D011014:Pneumonia / Q000188:drug therapy / Q000517:prevention & control*; D011446:Prospective Studies; D012121:Respiration, Artificial; D013407:Sulbactam / Q000627:therapeutic use*
C035444:sultamicillin; D000667:Ampicillin; D013407:Sulbactam