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Prophylaxis after first febrile urinary tract infection in children? A multicenter, randomized, controlled,
Giovanni Montini1, Luca Rigon, Pietro Zucchetta
1Department of Pediatric Nephrology, Azienda Ospedaliera-University of Padua, Italy. montini@pediatria.unipd.it
Insights
For children experiencing their first febrile urinary tract infection, antimicrobial prophylaxis does not significantly reduce recurrence rates compared to no prophylaxis. This finding applies to children with or without primary nonsevere reflux.
Area of Science:
- Pediatric infectious diseases
- Nephrology
- Clinical trials
Background:
- Febrile urinary tract infections (UTIs) are common in children and can lead to renal scarring and long-term complications.
- Antimicrobial prophylaxis is a strategy used to prevent recurrent febrile UTIs in pediatric populations.
- The efficacy of long-term antimicrobial prophylaxis in preventing recurrent febrile UTIs after a first episode remains a subject of investigation.
Purpose of the Study:
- To determine if 12 months of antimicrobial prophylaxis is similar to no prophylaxis in reducing febrile UTI recurrence in children after a first febrile UTI.
- To compare the rates of febrile UTI recurrence between children receiving prophylaxis and those not receiving prophylaxis.
- To assess the secondary outcome of renal scarring rates after 12 months.
Main Methods:
- A controlled, randomized, open-label, noninferiority trial was conducted.
- Participants included 338 children aged 2 months to <7 years with a first febrile UTI, including those with confirmed or clinical pyelonephritis with or without reflux.
- Children were assigned to either no prophylaxis or 12 months of prophylaxis (co-trimoxazole or co-amoxiclav).
Main Results:
- The primary outcome showed no significant difference in febrile UTI recurrence between the no prophylaxis group (9.45%) and the prophylaxis group (7.11%).
- In the subgroup of children with reflux, recurrence rates were 19.6% for no prophylaxis and 12.1% for prophylaxis, with no significant difference.
- No significant difference was observed in the secondary outcome of renal scarring between the groups (1.9% vs 1.1%). Grade III reflux was identified as a risk factor for recurrence.
Conclusions:
- Antimicrobial prophylaxis does not significantly reduce the rate of recurrent febrile urinary tract infections in children after a first episode, regardless of primary nonsevere reflux.
- No prophylaxis was not found to be a risk factor for recurrent febrile UTIs.
- Increasing age was found to be protective against recurrent febrile UTIs.
Objectives:
Febrile urinary tract infections are common in children and associated with the risk for renal scarring and long-term complications. Antimicrobial prophylaxis has been used to reduce the risk for recurrence. We performed a study to determine whether no prophylaxis is similar to antimicrobial prophylaxis for 12 months in reducing the recurrence of febrile urinary tract infections in children after a first febrile urinary tract infection.
Methods:
The study was a controlled, randomized, open-label, 2-armed, noninferiority trial comparing no prophylaxis with prophylaxis (co-trimoxazole 15 mg/kg per day or co-amoxiclav 15 mg/kg per day) for 12 months. A total of 338 children who were aged 2 months to <7 years and had a first episode of febrile urinary tract infection were enrolled: 309 with a confirmed pyelonephritis on a technetium 99m dimercaptosuccinic acid scan with or without reflux and 27 with a clinical pyelonephritis and reflux. The primary end point was recurrence rate of febrile urinary tract infections during 12 months. Secondary end point was the rate of renal scarring produced by recurrent urinary tract infections on technetium 99m dimercaptosuccinic acid scan after 12 months.
Results:
Intention-to-treat analysis showed no significant differences in the primary outcome between no prophylaxis and prophylaxis: 12 (9.45%) of 127 vs 15 (7.11%) of 211. In the subgroup of children with reflux, the recurrence of febrile urinary tract infections was 9 (19.6%) of 46 on no prophylaxis and 10 (12.1%) of 82 on prophylaxis. No significant difference was found in the secondary outcome: 2 (1.9%) of 108 on no prophylaxis versus 2 (1.1%) of 187 on prophylaxis. Bivariate analysis and Cox proportional hazard model showed that grade III reflux was a risk factor for recurrent febrile urinary tract infections. Whereas increasing age was protective, use of no prophylaxis was not a risk factor.
Conclusions:
For children with or without primary nonsevere reflux, prophylaxis does not reduce the rate of recurrent febrile urinary tract infections after the first episode.
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