title: Ceftibuten versus trimethoprim-sulfamethoxazole for oral treatment of febrile urinary tract infection in children.
abstract: A randomized, open, coordinated multi-center trial compared the bacteriological and clinical efficacy and safety of orally administered ceftibuten and trimethoprim-sulfamethoxazole (TMP-SMX) in children with febrile urinary tract infection (UTI). Children aged 1 month to 12 years presenting with presumptive first-time febrile UTI were eligible for enrollment. A 2:1 assignment to treatment with ceftibuten 9 mg/kg once daily (n = 368) or TMP-SMX (3 mg + 15 mg)/kg twice daily (n = 179) for 10 days was performed. Escherichia coli was recovered in 96% of the cases. Among the E. coli isolates, 14% were resistant to TMP-SMX but none to ceftibuten. In the modified intention-to-treat population, the bacteriological elimination rates at follow-up did not differ significantly between patients treated with ceftibuten and those treated with TMP-SMX [91 vs. 95%, with a 95% confidence interval (CI) for difference of -9.7 to 1.0]. However, the clinical cure rate was significantly higher among those treated with ceftibuten (93 vs. 83%, with a 95% CI for difference of 2.4 to 17.0). Adverse events were similar for both regimens and consisted mainly of gastrointestinal disturbances. In conclusion, ceftibuten is a safe and effective drug for the empirical treatment of febrile UTI in young children.
authors.affiliation: Department of Pediatrics, University of Gothenburg, Gothenburg, Sweden. staffan.marild@pediat.gu.se
authors.forename: Staffan
authors.initials: S
authors.lastname: Mårild
authors.forename: Ulf
authors.initials: U
authors.lastname: Jodal
authors.forename: Torsten
authors.initials: T
authors.lastname: Sandberg
mesh_terms: D000890:Anti-Infective Agents / Q000627:therapeutic use*; D000077722:Ceftibuten; D002511:Cephalosporins / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D005260:Female; D005334:Fever / Q000188:drug therapy; D006801:Humans; D007223:Infant; D008297:Male; D011446:Prospective Studies; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000009:adverse effects / Q000627:therapeutic use*; D014552:Urinary Tract Infections / Q000188:drug therapy*
chemical_list: D000890:Anti-Infective Agents; D002511:Cephalosporins; D015662:Trimethoprim, Sulfamethoxazole Drug Combination; D000077722:Ceftibuten