Trimethoprim-sulfamethoxazole for the prevention of spontaneous bacterial peritonitis in cirrhosis: a randomized trial.
OBJECTIVE
To assess the efficacy and safety of trimethoprim-sulfamethoxazole for the prevention of spontaneous bacterial peritonitis in patients with cirrhosis and ascites.


METHODS
A randomized controlled trial.


METHODS
University-affiliated Veterans Affairs medical center.


METHODS
60 consecutive patients with cirrhosis and ascites.


METHODS
Consecutive patients were randomly assigned to receive either no prophylaxis or trimethoprim-sulfamethoxazole, one double-strength tablet daily, five times a week (Monday through Friday). Patient entry was stratified by serum bilirubin (> 51 mumol/L [> 3 mg/dL]), ascitic fluid protein (< 1 g/dL), and serum creatinine (> 177 mumol/L [> 2 mg/dL]) levels to ensure that high-risk patients would be similarly distributed in the two groups. The median duration of follow-up for the study patients was 90 days.


METHODS
Spontaneous bacterial peritonitis or spontaneous bacteremia as defined by objective criteria.


RESULTS
Spontaneous bacterial peritonitis or spontaneous bacteremia developed in 27% (8 of 30) of patients who did not receive prophylaxis compared with 3% (1 of 30) of patients receiving trimethoprim-sulfamethoxazole (P = 0.025). Overall, infections developed in 9 of 30 patients (30%) not receiving prophylaxis and in 1 of 30 patients (3%) receiving trimethoprim-sulfamethoxazole (P = 0.012). Death occurred in 6 of 30 patients (20%) who did not receive prophylaxis and in 2 of 30 patients (7%) who received trimethoprim-sulfamethoxazole (P = 0.15). Side effects--particularly, hematologic toxicity--could not be attributed to trimethoprim-sulfamethoxazole in any patient.


CONCLUSIONS
Trimethoprim-sulfamethoxazole was efficacious, safe, and cost-effective for the prevention of spontaneous bacterial peritonitis in patients with cirrhosis.
Singh
N
N
Veterans Affairs Medical Center, Pittsburgh, Pennsylvania.
Gayowski
T
T
Yu
V L
VL
Wagener
M M
MM
D001201:Ascites / Q000150:complications; D016470:Bacteremia / Q000209:etiology / Q000517:prevention & control; D001424:Bacterial Infections / Q000209:etiology / Q000517:prevention & control*; D003362:Cost-Benefit Analysis; D006801:Humans; D008103:Liver Cirrhosis / Q000150:complications*; D010538:Peritonitis / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics
D015662:Trimethoprim, Sulfamethoxazole Drug Combination