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. 2020 Jan 16;2020(1):CD013125. doi: 10.1002/14651858.CD013125.pub2

Singh 1995.

Methods Randomised clinical trial
Participants Country: USA
Period of recruitment: not stated
Number randomised: 60
Postrandomisation dropouts: 0 (0%)
Revised sample size: 60
Mean age (years): 45
Females: not stated
Presence of other features of decompensation (hepatorenal syndrome, hepatic encephalopathy, or variceal bleeding): not stated
Ascites with low protein: not stated
Primary prophylaxis: 47 (78.3%)
Alcohol‐related cirrhosis: 24 (40.0%)
Viral‐related cirrhosis: 31 (51.7%)
Autoimmune disease‐related cirrhosis (e.g. PSC, PBC, AIH): not stated
Other causes for cirrhosis: 5 (8.3%)
Treated for ascites in addition to antibiotics (e.g. albumin or diuretics): not stated
Exclusion criteria:
  • allergy to sulfonamides

  • renal failure

  • active infections

Interventions Participants randomly assigned to 2 groups.
Group 1: sulfamethoxazole + trimethoprim (n = 30)
Further details: sulfamethoxazole 160 mg + trimethoprim 800 mg daily (duration not stated, but probably until follow‐up)
Group 2: no active intervention (n = 30)
Further details: no treatment
Outcomes Outcomes reported: all‐cause mortality; number of any adverse events per participant; proportion with spontaneous bacterial peritonitis (as per definition).
Follow‐up (months): 3
Notes Attempted to contact authors in November 2018, but received no replies.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: information not available
Allocation concealment (selection bias) Unclear risk Comment: information not available
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Comment: information not available
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: information not available
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no postrandomisation dropouts
Selective reporting (reporting bias) Low risk Comment: protocol not available, but authors reported mortality and adverse events adequately.
Other bias Low risk Comment: no other bias noted