Ericsson 1983.
Methods | Randomised, double‐blind, placebo‐controlled trial Method of randomisation not stated Patients kept daily diary of symptoms and medication doses |
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Participants | 148 US students attending summer school in Guadalajara, Mexico during the summer of 1980 Entry criteria: four or more unformed stools pers 24 hours or three unformed stools per 8 hours; diarrhoea of no more than 48 hours' duration; at least one of: abdominal pain, cramps, nausea, vomiting, fever |
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Interventions | Treatment: Bicozamycin 500 mg orally 4 times daily for 3 days Comparison: Placebo orally 4 times daily for 3 days |
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Outcomes | 1. Time from initiation of treatment to passage of last unformed stool 2. Number of unformed stools passed per 24 hour interval from initiation of treatment 3. Failed: Moderate to severe illness with more than 6 unformed stools per day and moderate cramps, nausea or vomiting | |
Notes | 97 participants (66%) had positive stool cultures Major pathogenic organisms: ETEC ‐ 49 (33%), Shigella ‐ 25 (17%), Salmonella ‐ 6 (4%), Rotavirus ‐ 5 (3%) Data on pre‐ and post‐treatment antibiotic sensitivities not reported |