Objectives: To assess the effectiveness of the adjunction of a one-gram single dose of ciprofloxacin to a symptomatic treatment for the early treatment of uncomplicated diarrhea during military operations of the French service members in Africa.
Patients and methods: This phase IV, multicentric, randomized, open-label, controlled trial was conducted in Chad, Mali, and in Central African Republic. A total of 267 French service members having at least one loose stool in the previous 24 hours were enrolled from May 2015 to June 2016. Participants were randomized to receive ciprofloxacin 1 g and a symptomatic treatment (racecadotril 100 mg three times a day and ad libidum oral rehydration solution) or a symptomatic treatment alone. The primary outcome was the duration of the diarrhea. Secondary outcomes were evaluated at the 72-hour endpoint and included recovery status, number of loose stools, frequency and duration of associated symptoms and safety of treatments.
Results: Among 267 participants, 242 completed the trial. Participants receiving ciprofloxacin and a symptomatic treatment (n = 124) were significantly more likely to be cured at the endpoint than those who only received a symptomatic treatment (118): 94.4 % versus 74.6 % (OR = 5.7; 95 %CI: [2.4-13.6]; p < 10-3). The antibiotic therapy reduced the average diarrhea duration by 30 % (p = 10-4). Fever at inclusion was associated with a longer episode (HR = 0.61; 95 %CI: [0.41-0.89]; p = 0.012). No adverse event of medications was reported.
Conclusion: A single dose of ciprofloxacin was effective and safe in treating uncomplicated diarrhea among service members in Africa.
Keywords: Ciprofloxacin; Military medicine; Randomized controlled trial; Traveler's diarrhea.
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