Single dose azithromycin versus ciprofloxacin for cholera in children: a randomized controlled trial.

OBJECTIVE To compare the clinical and bacteriological success of single dose treatment with azithromycin and ciprofloxacin in children with cholera. DESIGN Randomized, open labelled, clinical controlled trial. SETTING Tertiary care hospital. PARTICIPANTS 180 children between 2-12 years, having watery diarrhea for < or = 24 hr and severe dehydration, who tested positive for Vibrio cholerae by hanging drop examination or culture of stool. INTERVENTION Azithromycin 20 mg/kg single dose (n=91) or Ciprofloxacin 20 mg/kg single dose (n=89). Dehydration was managed according to WHO guidelines. MAIN OUTCOME MEASURES Clinical success (resolution of diarrhea within 24 hr) and bacteriological success (cessation of excretion of Vibrio cholerae by day 3). Secondary outcome variables included duration of diarrhea, duration of excretion of Vibrio cholerae in stool, fluid requirement, and proportion of children with clinical or bacteriological relapse. RESULTS The rate of clinical success was 94.5% (86/91) in children treated with Azithromycin and 70.7% (63/89) in those treated with Ciprofloxacin [RR (95% CI)=1.34 (1.16-1.54); P< 0.001]. Bacteriological success was documented in 100% (91/91) children in Azithromycin group compared to 95.5% (85/89) in Ciprofloxacin group [RR (95% CI)=1.05 (1.00 -1.10); P=0.06]. Patients treated with Azithromycin had a shorter duration of diarrhea [mean(SD) 54.6 (18.6) vs 71.5 (29.6) h; mean difference (95% CI) 16.9 (9.6 -24.2); P<0.001] and lesser duration of excretion of Vibrio cholerae [mean(SD) 34.6 (16.3) vs 52.1 (29.2) h; mean difference (95% CI) 17.5 (0.2 -24.7), P<0.001] in children treated with Azithromycin vs Ciprofloxacin. The amount of intravenous fluid requirement was significantly less among subjects who received Azithromycin as compared to those who received Ciprofloxacin [mean(SD) 4704.7(2188.4) vs 3491.1(1520.5) mL; Mean difference (95% CI) 1213(645.3 - 1781.9); P<0.001]. Proportion of children with bacteriological relapse was comparable in two groups [6.7% (6/89) vs 2.2% (2/91); RR (95% CI) 0.95 (0.89 -1.01); P=0.16]. None of the children in either group had a clinical relapse. CONCLUSION Single dose azithromycin is superior to ciprofloxacin for treating cholera in children.