Andremont 1981.
Methods | Design: randomised, placebo‐controlled, parallel‐group trial | |
Participants |
Number assigned: 48 adults (macrolide n = 24, placebo n = 24) Age in years: N/A Setting: healthy US residents travelling to Mexico to attend a professional meeting |
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Interventions |
Indication: prevention of traveller's diarrhoea Type of macrolide: erythromycin base Route: per oral Dose per day: 1000 mg Duration of treatment: mean days of treatment 6 (range 4 to 13 days) Total treatment dose: 6000 mg (mean) |
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Outcomes |
Adverse events stated as an outcome in trial registration/protocol/paper: no Adverse events ascertainment: unclear Adverse events: states that no adverse events were reported Antimicrobial resistance: not reported Death: not reported |
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Funding sources | Study supported by a "contrat de recherche clinique" from Institut Gustave Roussy and a grant from Roussel‐Uclaf Laboratories. | |
Notes |
Concomitant medication: unclear Note: gastrointestinal symptoms were reported as the primary outcome in this study and not reported/regarded as an adverse event. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
Allocation concealment (selection bias) | Unclear risk | Allocation not described. |
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 participants and clinicians |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropout |
Selective reporting (reporting bias) | Unclear risk | Adverse events not stated as an outcome and unclear ascertainment. However, states that no adverse events were reported. |
Other bias | Low risk | None were identified. |