Efficacy and safety of ciprofloxacin suspension in the treatment of childhood shigellosis(abstract)

Abstract

Objective: Compare the clinical and bacteriologic efficacy and toxicity of ciprofloxacin and amdinocillin pivoxyl in the treatment of shigellosis in children. Methodology: This randomized, double-blind, controlled clinical trial was conducted at the Dhaka Hospital of ICDDR.B from August 1995 to March 1997. Children aged 2-15 years with Shigelta-associated dysentery of <72 hours were eligible, provided their parents gave a written consent. Patients stayed in the hospital for 6 days and returned for follow-up evaluation 7 and 30 days after discharge. Assessment of joint symptoms and function was made daily and at follow-ups. Safety of the study drugs was evaluated in a total of 141 children enrolled in the study (70 in the ciprofloxacin group and 71 in the amdinocillin pivoxyl group), of whom the clinical and bacteriologic efficacy couid be evaluated in 120 children (60 children in each treatment group). Patients received either ciprofloxacin suspension, 10 mg/kg 12 hourly or amdinocillin pivoxyl tablets, 15-20 mg/kg 8 hourly for 5 days. Therapy was clinically effective, if a patient did not have frank dysentery on day 3; and had no bloody-mucoid stools on day 5, had <1 watery stool, <6 total stools, and was afebrile; and bacteriologically successful, or if Shigella could not be isolated from faecal samples on day 3 and thereafter. The rates of clinical and bacteriologic cure, and the rates and types of the adverse events in the two treatment groups were compared using the standard statistical tests. Results: Therapy was clinically successful in 48/60 (80%) and 39/60 (65%) patients (difference 15%; 95% CI -0.7-30.S), and bacteriologically successful in 60 (100%) and 54 (90%) patients (difference 10%; 95% CI 2.4-17.6%) who had received ciprofloxacin and amdinocillin respectively. Joint pain after initiation of therapy occurred in 13/ 70 (18.6%) and 16/71 (22.5%) patients who had received ciprofloxacin and amdinocillin respectively (p>0.2), and no patient had signs of arthritis. Conclusion: Ciprofloxacin is an effective and safe drug for use in multiply-resistant childhood shigellosis