Oral ciprofloxacin vs. intramuscular ceftriaxone as empiric treatment of acute invasive diarrhea in children

Background. Acute invasive diarrhea is a potentially serious condition in c hildren. Because of the increasing resistance of enteric pathogens to commo nly used oral antibiotics, intramuscular ceftriaxone has become the routine drug in the treatment of acute invasive diarrhea requiring an emergency vi sit in southern Israel, The inconvenience of this parenteral regimen create d an increased need for oral pediatric formulations for the treatment of in vasive diarrhea, Objectives. To evaluate the efficacy and safety of a suspension formulation of ciprofloxacin in the treatment of acute invasive diarrhea in infants an d children. Patients and methods. From July 1996 through December 1997, 201 evaluable c hildren ages 6 months to 10 years (35% <1 year; 70% <3 years) presenting wi th acute invasive diarrhea at the Pediatric Emergency Room were randomized to receive either ciprofloxacin suspension (10 mg/kg twice a day + im place bo; n = 95) or im ceftriaxone (50 mg/kg/day + placebo suspension; n = 106) for 3 days in a double blind manner. Stool cultures for Shigella, Salmonell a, Campylobacter spp, and diarrheagenic Escherichia coli were obtained on D ays 1, 3, 4 to 5 and 21 +/- 5, Clinical response and safety were assessed o n Days 1, 2, 3, 4 to 5 and 21 + 5, Results, We isolated 127 pathogens from 121 (60%) patients: 73 (57%) Shigel la; 23 (18%) Salmonella; 18 (14%) E.coli; and 13 (10%) Campylobacter, Overa ll bacteriologic eradication on Day 4 to 5 was 99% for Shigella, 77% for Sa lmonella and 77% for Campylobacter, with no difference between the 2 groups . Clinical cure or improvement was observed in 100 and 99% of the ciproflox acin and ceftriaxone groups, respectively. Serum ciprofloxacin values deter mined on Day 3 of the treatment were higher in the majority of patients tha n were the MIC50 and MIC90 values for the Shigella and Salmonella spp. isol ated. Possible drug-related adverse events occurred in 13 patients [ciprofl oxacin, 8 (8%); ceftriaxone, 5 (4.7%)] and were mild and transient. Joint e xamination was normal during and after completion of therapy in all patient s. Conclusion. Oral ciprofloxacin was as safe and effective as intramuscular c eftriaxone for the empiric treatment of acute invasive diarrhea in ambulato ry pediatric patients requiring an emergency room visit.