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

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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 enrolment. 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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Acknowledgements

We thank Nils Gunnar Pehrsson at the Statistiska Konsultgruppen for statistical support. The study was supported by a grant from the Schering-Plough.

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Authors and Affiliations

  1. Department of Pediatrics, Queen Silvia Children’s Hospital, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

    Staffan Mårild & Ulf Jodal

  2. Department of Infectious Diseases, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

    Torsten Sandberg

  3. The Queen Silvia Children’s Hospital, 416 85, Göteborg, Sweden

    Staffan Mårild

Authors
  1. Staffan Mårild
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  2. Ulf Jodal
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  3. Torsten Sandberg
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Correspondence to Staffan Mårild.

Additional information

This paper was written on behalf of all the members of the study group, which also includes: Elisabeth Esbjörner (Örebro University Hospital), Birgir Jakobsson (The Children’s Hospital at Huddinge), Tommy Linné (Karolinska University Hospital), Per-Olof Lübeck (Karlstad Hospital), Ingrid Sjöberg (Malmö University Hospital), Kerstin Abelson Storby (Växjö Hospital), Ingemar Tessin (Queen Silvia Children’s Hospital).

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Mårild, S., Jodal, U. & Sandberg, T. Ceftibuten versus trimethoprim-sulfamethoxazole for oral treatment of febrile urinary tract infection in children. Pediatr Nephrol 24, 521–526 (2009). https://doi.org/10.1007/s00467-008-0996-6

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  • DOI: https://doi.org/10.1007/s00467-008-0996-6

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