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. 2019 Jan 18;2019(1):CD011825. doi: 10.1002/14651858.CD011825.pub2

Giamarellos‐Bourboulis 2008.

Methods Design: randomised, placebo‐controlled, parallel‐group trial
Participants Number assigned: 200 adults and elderly (macrolide n = 100, placebo n = 100)
Age in years (mean ± SD): macrolide: 58.4 ± 20.7, placebo: 58.4 ± 17.4
Setting: secondary care
Interventions Indication: sepsis associated with ventilator‐associated pneumonia
Type of macrolide: clarithromycin
Route: intravenous
Dose per day: 1000 mg
Duration of treatment: 3 days
Total treatment dose: 3000 mg
Outcomes Adverse events stated as an outcome in trial registration/protocol/paper: no
Adverse events ascertainment: clinical examination (lab tests, ECG)
Adverse events: data reported
Antimicrobial resistance: not reported
Death: data reported
Funding sources Study supported by Abbott Laboratories. No information about their role in the study
Notes Concomitant medication: yes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The sequence was generated by an independent biostatistician and stratified by study site.
Allocation concealment (selection bias) Low risk Central allocation
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Identical‐appearing placebo
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Blinding of staff and participants
Incomplete outcome data (attrition bias) 
 All outcomes Low risk None lost to follow‐up. Report on reasons for discontinuation
Selective reporting (reporting bias) Unclear risk Adverse events not stated as an outcome. Only serious adverse events reported; info on QTc interval not presented even though ECG was performed.
Other bias Low risk None were identified.