Comparative efficacy of cefixime and ampicillin-sulbactam in shigellosis in children.

Shigellosis is still an important health problem in developing and underdeveloped countries as it is resistance to commonly used antibiotics including ampicillin, trimethoprim-sulfamethoxazole, chloramphenicol and tetracycline. Between May 1996 and October 1996, in a prospective randomized double-blind trial, cefixime was compared with ampicillin-sulbactam, both given orally for a period of 5 days, for the treatment of 80 children with acute bloody diarrhea. Forty patients were treated with a single-dose (8 mg/kg per day) of cefixime and the other 40 patients were given three doses of 100 mg/kg per day of ampicillin-sulbactam. After identification of Shigella organisms in stool specimens, nine patients in the cefixime receiving group and six patients in the ampicillin-sulbactam receiving group were excluded from the study. Differences in average age, sex and weight between the cefixime and ampicillin-sulbactam group were statistically meaningless (P > 0.05). Fever and bloody diarrhea were universal features. The efficacy of cefixime was found to be better than ampicillin-sulbactam. Patients given cefixime had a shorter duration of fever (P < 0.01), shorter duration to disappearance of blood in the stool (P < 0.01), reduced time with diarrhea (P < 0.01) and reduced hospitalization time during the 5 study days (P < 0.01) than patients given ampicillin-sulbactam. No adverse effects were observed in the two study groups. This controlled trial showed good efficacy with cefixime compared to ampicillin-sulbactam in the treatment of shigellosis. Single-dose daily oral therapy with cefixime also showed good tolerability. Cefixime should be considered as an alternative drug of choice for shigellosis in children.

RCT Entities:   Population Interventions Outcomes