Short Oral Antibiotic Therapy for Pediatric Febrile Urinary Tract Infections: A Randomized Trial
Giovanni Montini1,2, Antimo Tessitore3, Karen Console3
1Pediatric Nephrology, Dialysis and Transplant Unit, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milano, Italy.
Insights
A 5-day amoxicillin-clavulanate course effectively treats febrile urinary tract infections (fUTIs) in children, showing noninferiority to the standard 10-day regimen. This shorter treatment reduces recurrence rates and offers a potentially more convenient option for pediatric fUTI management.
Area of Science:
- Pediatric infectious diseases
- Antibiotic stewardship
- Clinical trial methodology
Background:
- Febrile urinary tract infections (fUTIs) in children are typically treated with 10-day oral antibiotics.
- Optimizing antibiotic duration is crucial for effective treatment and reducing resistance.
Purpose of the Study:
- To evaluate the noninferiority of a 5-day amoxicillin-clavulanate course versus a 10-day course for treating fUTIs in children.
- To assess recurrence rates, clinical recovery, and adverse events associated with shorter antibiotic durations.
Main Methods:
- A multicenter, randomized, controlled trial involving children aged 3 months to 5 years with uncomplicated fUTI.
- Participants received amoxicillin-clavulanate for either 5 or 10 days.
- Primary endpoint: fUTI recurrence within 30 days post-therapy.
Main Results:
- The 5-day group had a recurrence rate of 2.8% compared to 14.3% in the 10-day group.
- The recurrence rate of fUTI within 30 days was 1.4% in the short group and 5.7% in the standard group.
- The 5-day regimen demonstrated noninferiority to the 10-day regimen.
Conclusions:
- A 5-day course of oral amoxicillin-clavulanate is noninferior to a 10-day course for treating fUTIs in children.
- Shorter antibiotic durations may be a viable option for pediatric fUTI management.
- Further research could explore long-term outcomes and resistance patterns.
Background And Objectives:
Febrile urinary tract infection (fUTI) in well-appearing children is conventionally treated with a standard 10-day course of oral antibiotic. The objective of this study is to determine the noninferiority (5% threshold) of a 5-day amoxicillin-clavulanate course compared with a 10-day regimen to treat fUTIs.
Methods:
This is a multicenter, investigator-initiated, parallel-group, randomized, controlled trial. We randomly assigned children aged 3 months to 5 years with a noncomplicated fUTI to receive amoxicillin-clavulanate 50 + 7.12 mg/kg/day orally in 3 divided doses for 5 or 10 days. The primary end point was the recurrence of a urinary tract infection within 30 days after the completion of therapy. Secondary end points were the difference in prevalence of clinical recovery, adverse drug-related events, and resistance to amoxicillin-clavulanic acid and/or to other antibiotics when a recurrent infection occurred.
Results:
From May 2020 through September 2022, 175 children were assessed for eligibility and 142 underwent randomization. The recurrence rate within 30 days of the end of therapy was 2.8% (2/72) in the short group and 14.3% (10/70) in the standard group. The difference between the 2 groups was -11.51% (95% confidence interval, -20.54 to -2.47). The recurrence rate of fUTI within 30 days from the end of therapy was 1.4% (1/72) in the short group and 5.7% (4/70) in the standard group (95% confidence interval, -10.4 to 1.75).
Conclusions:
This study demonstrates that a 5-day course is noninferior to a 10-day course of oral amoxicillin-clavulanate.
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