Noncomparative, open label, multicenter trial of cefixime for treatment of bacterial pharyngitis, cystitis and pneumonia in pediatric patients.
Cefixime, a new third generation oral cephalosporin antibiotic, was evaluated for safety and efficacy in the treatment of 206 children with acute bacterial pharyngitis, cystitis or pneumonia. Each patient had a throat, urine or sputum culture before therapy and was treated with a 10- to 14-day course of cefixime, 8 mg/kg once daily. Bacterial pathogens were isolated in 167 of 206 (81.1%). Streptococcus pyogenes (73.7% of isolates) and Escherichia coli (9.6%) were the most common Gram-positive and Gram-negative organisms, respectively. All patients were evaluable for safety, and 109 (52.9%) with pharyngitis (96) or cystitis (13) were evaluable for efficacy. Clinical failure occurred in 2 of 109 (1.8%) patients, both with pharyngitis; bacteriologic failure occurred in 1 patient with pharyngitis and 1 with cystitis. Five patients with pneumonia caused by possible pathogens also improved while taking cefixime. Drug-related adverse side effects occurred in 50 of 206 patients (24.3%); these were generally mild and led to discontinuing the antibiotic in only 4 patients (1.9%). The most common were diarrhea or loose stools (33 of 206, or 16%). Results of this study suggest that cefixime given once daily to children is safe and effective in the treatment of streptococcal pharyngitis and bacterial cystitis.
Risser
W L
WL
Department of Pediatrics, University of Texas Health Science Center, Houston 77225.
Barone
J S
JS
Clark
P A
PA
Simpkins
D L
DL
D000293:Adolescent; D020682:Cefixime; D002439:Cefotaxime / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D003556:Cystitis / Q000188:drug therapy* / Q000382:microbiology; D003967:Diarrhea / Q000139:chemically induced; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010612:Pharyngitis / Q000188:drug therapy* / Q000382:microbiology; D011014:Pneumonia / Q000188:drug therapy* / Q000382:microbiology
D020682:Cefixime; D002439:Cefotaxime