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 |
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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 |
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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 |
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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. |