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Ceftibuten versus trimethoprim-sulfamethoxazole for oral treatment of febrile urinary tract infection in children

Journal article
Authors Staffan Mårild
Ulf Jodal
Torsten Sandberg
Published in Pediatric Nephrology
Volume 24
Issue 3
Pages 521-6
ISSN 0931-041X
Publication year 2009
Published at Institute of Biomedicine, Department of Infectious Medicine
Institute of Clinical Sciences
Pages 521-6
Language en
Keywords Anti-Infective Agents/*therapeutic use, Cephalosporins/adverse effects/*therapeutic use, Child, Child, Preschool, Female, Fever/drug therapy, Humans, Infant, Male, Prospective Studies, Trimethoprim-Sulfamethoxazole Combination/adverse effects/*therapeutic use, Urinary Tract Infections/*drug therapy
Subject categories Medical and Health Sciences


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.

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