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:
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| 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 |
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| 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 |
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| Notes | Trial name/trial registry number: CCT‐NAPN‐16065 Attempted to contact authors in November 2018, but received no replies. |
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| 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 |