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

Terg 2008.

Methods Randomised clinical trial
Participants Country: Argentina
Period of recruitment: 2000–2005
Number randomised: 100
Postrandomisation dropouts: 0 (0%)
Revised sample size: 100
Mean age (years): 57
Females: not stated
Presence of other features of decompensation (hepatorenal syndrome, hepatic encephalopathy, or variceal bleeding): not stated
Ascites with low protein: 100 (100%)
Primary prophylaxis: 100 (100%)
Alcohol‐related cirrhosis: not stated
Viral‐related cirrhosis: not stated
Autoimmune disease‐related cirrhosis (e.g. PSC, PBC, AIH): not stated
Other causes for cirrhosis: not stated
Treated for ascites in addition to antibiotics (e.g. albumin or diuretics): not stated
Exclusion criteria:
  • antibiotics in the previous 30 days

  • pregnancy

  • active gastrointestinal bleeding

  • encephalopathy > grade 2

  • hepatocellular carcinoma or other malignancies

  • allergy to quinolones

  • renal or liver failure

  • bacterial infection

Interventions Participants randomly assigned to 2 groups.
Group 1: ciprofloxacin (n = 50)
Further details: ciprofloxacin 500 mg/day (duration not stated – probably until end of follow‐up)
Group 2: no active intervention (n = 50)
Further details: placebo
Outcomes Outcomes reported: all‐cause mortality; number of any adverse events per participant; proportion with spontaneous bacterial peritonitis (as per definition)
Follow‐up (months): 8
Notes Trial name/trial registry number: CCT‐NAPN‐16065
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) Low risk Quote: "Randomization was performed with sealed and consecutively numbered opaque envelopes containing the treatment option as derived from computer generated random numbers."
Allocation concealment (selection bias) Low risk Quote: "Randomization was performed with sealed and consecutively numbered opaque envelopes containing the treatment option as derived from computer generated random numbers."
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "Multicenter, randomized, double blind, and placebo‐controlled study."
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Multicenter, randomized, double blind, and placebo‐controlled study."
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