Use of oral amoxicillin-clavulanic acid for 5 days was noninferior to a 10-day course of treatment among children with noncomplicated febrile urinary tract infections (UTIs), according to new research.
Well-appearing children with febrile UTIs are generally treated with a 10-day course of oral antibiotics, but the effectiveness of a 5-day course has not been evaluated, wrote Giovanni Montini, MD, of the University of Milano, Italy, and colleagues.
Robert W. Frenck, Jr, MD, a director of the Center for Vaccine Research at Cincinnati Children's Hospital Medical Center, Ohio, said he was not surprised that the shorter course was sufficient to treat these cases. The antibiotic concentration in the urine often significantly exceeds the levels in the blood, he said.
Frenck, who was not involved in the study, said that he saw no real barriers to the use of a shorter course of therapy in clinical practice.
"I think both parents and the medical team would be happy to be able to use a shorter course of therapy," he said.
In the study published in Pediatrics, researchers randomized 142 children aged 3 months to 5 years with uncomplicated febrile UTIs to 50 mg/kg/d of amoxicillin-clavulanate for either the short or standard period. The study took place at eight pediatric emergency departments in Italy between May 2020 and September 2022. All patients received prescriptions for 5 days of antibiotics, and those randomized to the standard course received a second prescription after randomization.
The primary endpoint was recurrence of the UTI within 30 days of completion of therapy. Secondary endpoints included clinical recovery at the end of treatment, adverse events related to the therapy, and signs of antibiotic resistance.
The UTI recurrence rate within 30 days of treatment completion was 2.8% in the short-course group and 14.3% in the standard group. A post hoc analysis excluding patients with vesicoureteral reflux and non-Escherichia coli UTIs further confirmed the noninferiority of short-course treatment.
"It is a bit surprising that the short-course group had fewer relapses within 30 days of discontinuing antibiotics," Frenck said. "However, the differences may be due to small sample sizes and do not appear to be statistically significant differences in recurrence rates."
Resolution of symptoms was similar between the short-course and standard groups (97.2% and 92.9%, respectively), and indications of antibiotic resistance were similar between the groups. No adverse events were reported in the standard group, and one case of diarrhea occurred in the short-course group.
The findings were limited by the study's unblinded randomization, so parents were aware of the trial and were potentially sensitized to look for signs of infection. Researchers also relied on parent reports of adverse drug effects rather than through a standardized questionnaire, the researchers noted.
Frenck said a potential benefit to shortening treatment is that adherence usually increases.
"But you only want to decrease the length of a course of medicine if you can do so without compromising the effectiveness of the treatment," Frenck said.
Frenck also noted a recent study, which demonstrated that 5 days of antibiotics had equivalent efficacy as 10 days for uncomplicated pneumonia.
"The current paper further demonstrates that shorter courses of antibiotics may be possible for other mild forms of infections."
Looking ahead, researchers could evaluate the use of short-course antibiotics for other common infections such as otitis media, he noted.
The study was supported by the Ministry of Health, Rome, Italy, in collaboration with the Institute for Maternal and Child Health IRCCS Burlo Garofolo, Trieste, Italy. The researchers report no financial conflicts. Frenck disclosed conducting clinical trials for Pfizer, Moderna, AstraZeneca, Merck, and GSK; none of those trials were for antibiotics or urinary tract infections.
Heidi Splete is a freelance journalist.
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