A randomized clinical trial to compare the efficacy of erythromycin, ampicillin and tetracycline for the treatment of cholera in children.
To compare the clinical outcome of treatment of cholera in children with ampicillin, erythromycin or tetracycline, a double-'blind' randomized four-cell trial was carried out in Bangladesh. Ampicillin was chosen as additional therapy for acute respiratory tract infection, present in many subjects with diarrhoea. One hundred and eighty-four children aged 1-5 years who were not wasted, with diarrhoea of duration < 48 h, signs of some or severe dehydration, dark-field stool microscopy demonstrating Vibrio cholerae, and a baseline purging rate > 4 mL/kg/h over 6 h were enrolled in the study. Ampicillin, tetracycline, erythromycin or placebo were given orally every 6 h for 3 d. After 3 d of antibiotic treatment, diarrhoeal stool volume was significantly reduced in all antibiotic groups, with mean volumes per kg body weight as follows: tetracycline, 318 mL (SEM = 50), ampicillin, 335 mL (SEM = 30); erythromycin, 323 mL (SEM = 25); placebo, 498 mL (SEM = 37). Compared to tetracycline, the clinical recovery rates by 96 h were 75% with placebo, 91.3% with ampicillin, and 95.7% with eythromycin. Compared to tetracycline, the total mean times to recovery were increased by 66% with placebo (P < 0.001), 25% with ampicillin (P < 0.017), and 9% with erythromycin (P = 0.37). These results indicated comparable clinical efficacy of tetracycline, ampicillin and erythromycin. We therefore recommend that, unless V. cholerae is resistant, ampicillin should be used as a cost-effective alternative to erythromycin for paediatric cholera, especially in children with concomitant acute respiratory infection.