DuPont 1992b.
Methods | Randomised, double‐blind, placebo‐controlled trial Method of randomisation not stated Two patients were assigned ofloxacin for every patient assigned placebo Patients kept daily diary of symptoms and medication doses Patients were seen daily and questioned by investigators |
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Participants | 232 US students attending summer school in Guadalajara, Mexico during the period from June 1986 and December 1988 Entry criteria: four or more unformed stools pers 24 hours or three unformed stools per 8 hours; diarrhoea of no more than 60 hours' duration; other abdominal complaints, such as abdominal discomfort, urgency; or fever |
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Interventions | Treatment groups:
1. Ofloxacin 300 mg orally twice daily for three days
2. Ofloxacin 300 mg orally twice daily for five days Placebo groups: 3. Placebo orally twice daily for three days 4. Placebo orally twice daily for five days |
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Outcomes | 1. Clinical response 2. Cure: complete resolution of illness 3. Duration of post treatment diarrhoea 4. Failure: Deterioration of clinical status during treatment or diarrhoea persisting 5 days or longer after treatment was begun | |
Notes | 103 participants (44%) had 124 pathogens isolated Major pathogenic organisms: ETEC ‐ 66 (28%), Shigella ‐ 24 (10%), Plesiomonas ‐14 (6%) Others: Aeromonas, Campylobacter, ETEC, Salmonella Pre‐ and post‐treatment antibiotic sensitivities not reported |