According to a new study, the use of oral amoxicillin-clavulanic acid for 5 days was not inferior to a 10-day treatment for children with uncomplicated febrile urinary tract infections (UTIs).
Good-looking children with febrile UTIs are generally treated with a 10-day course of oral antibiotics, but the efficacy of a 5-day treatment had not been evaluated, wrote Dr. Giovanni Montini from the University of Milan, Italy, and colleagues.
Robert W. Frenck, Jr., MD, Director of the Center for Vaccine Research at Cincinnati Children’s Hospital Medical Center, Ohio, said he wasn’t surprised that the shorter treatment duration was sufficient to treat these cases. He explained that antibiotic concentration in the urine often exceeds values in the blood.
Frenck, who was not involved in the study, stated that he saw no real barriers to implementing a shorter treatment duration in clinical practice. „I think both parents and the medical team would appreciate a shorter course of therapy,“ he said.
Published in Pediatrics, the study randomly assigned 142 children aged 3 months to 5 years with uncomplicated febrile UTIs to receive a 5-day or standard oral Amoxicillin-Clavulanate treatment of 50 mg/kg/day. The study took place between May 2020 and September 2022 in eight pediatric emergency departments in Italy. All patients were prescribed antibiotics for 5 days, and those randomized to the standard treatment arm received a second prescription post-randomization.
The primary endpoint was UTI recurrence within 30 days after completing the therapy. Secondary endpoints included clinical recovery at the end of treatment, therapy-related adverse events, and signs of antibiotic resistance.
The 30-day UTI recurrence rate after discontinuation of antibiotics 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 non-inferiority of the short-course treatment.
„It is a bit surprising that the short-course group had fewer recurrences within 30 days after stopping the antibiotics,“ said Frenck. „However, the differences may be due to small sample sizes and do not appear to be statistically significant differences in recurrence rates.“
Symptom resolution was similar in the short-course and standard groups (97.2% and 92.9%, respectively), and signs of antibiotic resistance were similar in both groups. No adverse events were reported in the standard group, and one case of diarrhea occurred in the short-course group.
The study was limited by the unblinded randomization, so parents were aware of the study and may have been sensitized to look for signs of infection. The researchers also relied on parental reports of drug-related adverse events rather than a standardized questionnaire, the researchers noted.
Frenck stated a potential benefit of shortening the treatment duration is that therapy adherence typically increases. „But you only want to shorten the duration of treatment if it can be done without compromising treatment efficacy,“ said Frenck.
Frenck also referenced a recent study showing that a 5-day antibiotic therapy for uncomplicated pneumonia was as effective as a 10-day treatment. „The current paper also shows that shorter courses of antibiotics may be possible for other mild forms of infections,“ he added.
In the future, researchers may 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 these studies focused on antibiotics or UTIs.
Heidi Splete is a freelance journalist.