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

Piano 2016.

Methods Randomised clinical trial
Participants Country: Italy
Number randomised: 32
Post‐randomisation dropouts: 1
Revised sample size: 31
Average age: 60 years
Females: 12 (38.7%)
Presence of other features of decompensation (hepatorenal syndrome, hepatic encephalopathy, or variceal bleeding): not stated
Alcohol‐related cirrhosis: both
Viral‐related cirrhosis: both
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: 3
Years of recruitment: 2011‐2014
Inclusion criteria
  • Nosocomial SBP


Exclusion criteria
  • Secondary peritonitis

  • Onset of infection ≤ 72 hours from hospitalisation

  • Abdominal surgery in the previous 4 weeks

  • Hepatocellular carcinoma beyond the Milan Criteria

  • Congestive heart failure and/or respiratory failure

  • Treatment with third‐generation cephalosporins, carbapenems or daptomycin at the time of diagnosis of SBP

  • Isolation of bacteria resistant to third‐generation cephalosporins, carbapenems and/or daptomycin in cultures performed in the previous 7 days

  • Allergy to ceftazidime, meropenem and/or daptomycin

Interventions Participants were randomly assigned to two groups.
 Group 1: ceftazidime (n = 16)
 Further details: ceftazidime 2 g/day to 6 g/day depending on glomerular filtration rate for at least 7 days
 Group 2: meropenem + daptomycin (n = 15)
 Further details: meropenem 0.5 g to 3 g/day plus daptomycin 3 mg/Kg/day to 6 mg/Kg/day depending on glomerular filtration rate for at least 7 days
Outcomes Outcomes reported
  • Mortality

  • Serious adverse events (number of people)

  • Any adverse events (number of people)

  • Liver transplantation

  • Proportion with recovery from SBP

  • Other features of decompensation

Notes Attempts were made to contact the authors in December 2018; there were no replies.
Reason for post‐randomisation dropout: secondary peritonitis
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization was performed using consecutively numbered, computer‐generated, sealed, opaque envelopes containing the treatment assigned."
Allocation concealment (selection bias) Low risk Quote: "Randomization was performed using consecutively numbered, computer‐generated, sealed, opaque envelopes containing the treatment assigned."
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: "Independent laboratory examiners, blinded to assigned treatment, manually assessed the ascitic fluid PMN count".
Comment: it is not clear whether patients and healthcare providers were blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: "Independent laboratory examiners, blinded to assigned treatment, manually assessed the ascitic fluid PMN count".
Comment: it is not clear whether patients and healthcare providers were blinded.
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.