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. 2019 Sep 16;2019(9):CD013120. doi: 10.1002/14651858.CD013120.pub2

Navasa 1996.

Methods Randomised clinical trial
Participants Country: Spain
Number randomised: 132
Post‐randomisation dropouts: 9
Revised sample size: 123
Average age: 59 years
Females: 44 (35.8%)
Presence of other features of decompensation (hepatorenal syndrome, hepatic encephalopathy, or variceal bleeding): both
Alcohol‐related cirrhosis: both
Viral‐related cirrhosis: not stated
Autoimmune disease‐related cirrhosis (e.g. PSC, PBC, AIH): not stated
Other causes for cirrhosis: both
Treated for ascites in addition to antibiotics (e.g. albumin or diuretics): not stated
Follow‐up in months: 0.5
Years of recruitment: 1992‐1994
Exclusion criteria
  • Absence of severe complications at infection diagnosis, i.e. shock, gastrointestinal haemorrhage, renal impairment or grade II‐IV hepatic encephalopathy

  • Antibiotic treatment within 2 weeks before inclusion

  • History of hypersensitivity to quinolones or beta‐lactam antibiotics

Interventions Participants were randomly assigned to two groups.
 Group 1: ofloxacin (n = 64)
 Further details: ofloxacin 100 mg/day to 800 mg/day depending upon creatinine levels (4 days to 2 weeks)
 Group 2: cefotaxime (n = 59)
 Further details: cefotaxime 1 g/day to 8 g/day depending upon creatinine levels (4 days to 2 weeks)
Outcomes Outcomes reported
  • Mortality

  • Proportion with recovery from SBP

  • Other features of decompensation

  • Length of hospital stay

Notes We were unable to locate the current contact details of the author.
Reason for post‐randomisation dropouts: secondary peritonitis, voluntary dropout
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization was performed with sealed envelopes containing the treatment options prepared with random numbers generated by the SAS statistical package (SAS Institute Inc., Cary, NC)".
Allocation concealment (selection bias) Low risk Quote: "Randomization was performed with sealed envelopes containing the treatment options prepared with random numbers generated by the SAS statistical package (SAS Institute Inc., Cary, NC)".
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Comment: this information was not available.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: this information was not available.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: there were post‐randomisation dropouts; it is not clear whether this was related to treatment and/or outcomes.
Selective reporting (reporting bias) Low risk Comment: a prepublished protocol was not available but the authors report routinely measured clinical outcomes adequately.
Other bias Low risk Comment: no other bias was noted.