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Single-dose ciprofloxacin versus 12-dose erythromycin for childhood cholera: a randomised controlled trial

2005; Elsevier BV; Volume: 366; Issue: 9491 Linguagem: Inglês

10.1016/s0140-6736(05)67290-x

1474-547X

Debasish Saha, Wasif Ali Khan, Mohammad Mahbubul Karim, Hafizur Rahman Chowdhury, Mohammed Abdus Salam, Michael L. Bennish,

Antibiotic Resistance in Bacteria

Background Single-dose ciprofloxacin is effective for the treatment of severe cholera in adults. We assessed whether single-dose ciprofloxacin would be as effective as 3-day, 12-dose erythromycin in achieving clinical cure in children with severe cholera. Methods We did a randomised, open label, controlled trial in children age 2–15 years with V cholerae O1 or O139 present in stool on dark-field microscopy. Children received either a single 20 mg/kg dose of ciprofloxacin (n=90) or 12·5 mg/kg of erythromycin (n=90) every 6 h for 3 days, and remained in hospital for 5 days. The primary outcome was clinical success of treatment, defined as cessation of watery stools within 48 h of start of drug treatment. Analysis was per protocol. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN00142272. Findings Of 180 children randomised 162 completed the study. Treatment was clinically successful in 60% (47/78) of children treated with ciprofloxacin and in 55% (46/84) of those treated with erythromycin (difference 5% [95% CI −10 to 21]). Children receiving ciprofloxacin vomited less often (58% vs 74%; difference 16% [2 to 30]), had fewer stools (15 vs 21; 6 [0 to 9]), and less stool volume (152 vs 196 mL/kg; 43 mL/kg [13 to 87]) than those receiving erythromycin. Bacteriological failure was more common in ciprofloxacin-treated patients (58% vs 30%; 28% [13 to 43]) than erythromycin-treated patients. Interpretation Single-dose ciprofloxacin achieves clinical outcomes similar to, or better than, those achieved with 12-dose erythromycin treatment in childhood cholera, but is less effective in eradicating V cholerae from stool.