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. 2010 Sep 8;2010(9):CD002907. doi: 10.1002/14651858.CD002907.pub2

Pauwels 1996.

Methods Data collection: 12/89 to 03/92. 
 Exclusion from analysis: infection on admission, undergoing surgery within 24 hs after admission, or death in the first 12 h. 
 Follow‐up period: up to 10 days after stopping bleeding (four weeks).
Participants France 
 Hospitalised cirrhotic patients with upper gastrointestinal haemorrhage, without infection, or treatment with antibiotics in the previous week. 
 Etiology of bleeding: oesophageal or gastric varices, gastric or duodenal ulceration, and others.
Initial infection assessment: chest X‐ray, white blood cell count, urine/blood/ascites culture. 
 Source of bleeding determined by endoscopy scheduled within 12 hs after enrolment. 
 Emergency sclerotherapy performed for patients bleeding from varices. 
 Child‐Pugh class A/B/C: 16/54/49.
Interventions Experimental (Group III): intravenous + oral ciprofloxacin 400mg per day, amoxicillin‐clavulanic acid 3g per day, until three days after cessation of haemorrhage.
Control (Group I and II): no antibiotic prophylaxis.
Outcomes Prevention of bacterial infections.
Notes Two group of patients received no intervention and were combined for the purpose of this review.
Authors were contacted for the first version of this review.
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Low risk The sequence was generated using a table of random numbers.
Allocation concealment? Unclear risk No information provided.
Blinding? 
 All outcomes High risk Not a blinded trial.
Incomplete outcome data addressed? 
 All outcomes Low risk Missing data are balanced in number across the intervention groups.
Free of selective reporting? Low risk The report include all the expected outcomes.
Free of other bias? Low risk The trial appears to be free of other sources of bias.
Intention to treat analysis? High risk The exclusion of the patients was based on an exclusion rule.
Sample calculation? High risk No sample calculation procedure.