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
Exclusion criteria
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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
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Notes | Attempts were made to contact the authors in December 2018; there were no replies. Reason for post‐randomisation dropout: secondary peritonitis |
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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. |