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Published on: July 12, 2018
Single dose azithromycin versus ciprofloxacin for cholera in children: a randomized controlled trial
Jaya Shankar Kaushik1, Piyush Gupta, M Ma Faridi
1Department of Pediatrics University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi, India. jayashankarkaushik@gmail.com
Insights
Single dose azithromycin is more effective than ciprofloxacin for treating childhood cholera, leading to faster recovery and reduced fluid needs. This study highlights azithromycin as a superior treatment option for pediatric cholera cases.
Area of Science:
- Pediatric infectious diseases
- Antimicrobial therapy
- Gastroenterology
Background:
- Cholera remains a significant public health concern, particularly in pediatric populations.
- Effective antibiotic treatment is crucial for managing cholera and preventing complications.
- Comparing single-dose antibiotic regimens can optimize treatment protocols.
Purpose of the Study:
- To evaluate and compare the clinical and bacteriological efficacy of single-dose azithromycin versus ciprofloxacin in children diagnosed with cholera.
- To determine the superiority of one antibiotic over the other in terms of treatment outcomes.
Main Methods:
- A randomized, open-label clinical trial was conducted with 180 children aged 2-12 years presenting with severe dehydration and confirmed Vibrio cholerae infection.
- Participants received either a single dose of azithromycin (20 mg/kg) or ciprofloxacin (20 mg/kg).
- Clinical success was defined as diarrhea resolution within 24 hours, and bacteriological success as cessation of Vibrio cholerae excretion by day 3.
Main Results:
- Azithromycin demonstrated significantly higher clinical success rates (94.5%) compared to ciprofloxacin (70.7%) (P<0.001).
- Bacteriological success was nearly complete in both groups, with a trend favoring azithromycin (100% vs 95.5%, P=0.06).
- Children treated with azithromycin experienced shorter diarrhea duration, reduced Vibrio cholerae excretion time, and lower intravenous fluid requirements.
Conclusions:
- Single-dose azithromycin is clinically and bacteriologically superior to single-dose ciprofloxacin for the treatment of cholera in children.
- Azithromycin offers advantages in terms of faster symptom resolution and reduced healthcare resource utilization.
- The findings support azithromycin as a preferred first-line treatment for pediatric cholera.
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.
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