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STOP RCT – Duration of Antibiotics for Pediatric Febrile UTI

April 9, 2024

Written by Laura Murphy

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The Short-Course Oral Antibiotic Therapy of Acute Pyelonephritis (STOP trial) demonstrated that a 5-day course of amoxicillin-clavulanate was noninferior to the standard 10-day course with regard to recurrence of infection.

Should we STOP antibiotics sooner?
This was a multicenter, parallel-group, randomized controlled trial that compared a 5 versus 10-day course of oral amoxicillin-clavulanate for treatment of uncomplicated febrile urinary tract infection (fUTI) in children from 3 months to 5 years old. A total of 142 patients from 8 Italian pediatric emergency departments between May 2020 and September 2022 were randomized.  Primary end point was recurrence of UTI within 30 days of completion of therapy, and secondary end points were clinical recovery at the end of treatment (complete resolution of fever or other symptoms present at onset), adverse events related to amoxicillin-clavulanate therapy, and antimicrobial resistance. Groups were overall well-matched, and E. coli was the prevalent microorganism in both groups. The study excluded patients with complicated fUTI (fever>48 hours after starting treatment), need to change antibiotic regimen, dehydration, vomiting, adherence concerns, presence of catheter, immunodeficiency, or neurogenic bladder.

Recurrence rate was 2.8% (2/72) in the short group, and 14.3% (10/70) in the standard group, with a difference of -11.51% (95% CI, -20.54 to -2.47), suggesting that a 5-day treatment course is noninferior to the standard 10-day course. There were no significant differences between groups with regard to secondary endpoints. Due to the small sample size for resistant pathogens, these results have limited generalizability.

This study was stopped early at 2 year interim analysis after meeting pre-specified criteria of difference between the two groups with P<0.005 (CI 99.5%), allowing for early cessation. Authors noted low recruitment due to reduced access to pediatric emergency departments attributed to COVID-19 pandemic. Given the small sample size, additional studies will be needed to confirm best practices.

These results contrast with those of the larger SCOUT trial (covered by JournalFeed here). While there are key differences in study design which may explain differing results, further studies to validate results of this trial are likely needed prior to shift in guidelines. Notably, the rate of treatment failure in the short-course group was relatively low in the SCOUT trial, and authors conclude that a short course of antibiotics may be reasonable for children with clinical improvement at 5 days.

How will this change my practice?
I am unlikely to shift my practice to a 5-day antibiotic course for uncomplicated fUTI in young children based solely on these results. However, this study suggests that shorter courses are likely reasonable for patients with close follow up or those who have adverse antibiotic effects. I will certainly be on the lookout for further studies determining the optimal antibiotic duration for these patients.

STOP Trial Group. Short Oral Antibiotic Therapy for Pediatric Febrile Urinary Tract Infections: A Randomized Trial. Pediatrics. 2024 Jan 1;153(1):e2023062598. doi: 10.1542/peds.2023-062598.