In a retrospective study across five U.S. pediatric hospitals, researchers found that more than half of pediatric and adolescent patients treated with fidaxomicin for Clostridioides difficile infections were clinically cured within 2 weeks, and fewer than one-quarter of them experienced recurrence by day 60.
In the study, the researchers included 95 patients aged 12 months to 18 years who were treated for either primary or recurrent C difficile infections (CDI) between 2013 and 2021. Most (88%) were treated for recurrent infections, and 86% had underlying medical or surgical conditions, including inflammatory bowel disease (IBD), bowel surgery, feeding tube dependence, or prior organ transplantation.
By day 14 of treatment, 53% were classified as cured with complete resolution of symptoms, and 30% showed improvement. Sixteen percent didn't respond to treatment. Among the 79 patients who responded, 21.5% had a recurrence by day 60, defined as return of symptoms with a positive C difficile test.
Most patients received a 10-day course of fidaxomicin, though a few were treated for up to 30 days. Clinical response was assessed through chart review. Recurrence was measured only in those who initially improved and had documented symptomatic relapse confirmed by testing.
IBD was associated with a lower rate of clinical cure at day 14. In multivariable analysis, the rate of cure in patients with IBD was reduced (odds ratio [OR] = 0.32, 95% confidence interval [CI] = 0.11–0.94). Prior fecal microbiota transplantation also correlated with reduced likelihood of cure (OR = 0.28. 95% CI = 0.09–0.80).
Among patients who responded, those with IBD didn't have a higher rate of recurrence by day 60 compared with those without IBD. However, patients with a history of solid organ transplantation had a higher risk of recurrence (OR = 7.98, 95% CI = 2.11–30.16).
Reported adverse events were generally mild and included abdominal pain (9.5%), nausea (6%), vomiting (4%), and IBD exacerbations (4%). Seven patients were hospitalized during or shortly following treatment, though the cause couldn't be definitively linked to fidaxomicin because of underlying conditions.
The study provided real-world evidence on fidaxomicin use in pediatric patients, supplementing previous trials that focused on healthier populations. Unlike those earlier studies, this cohort included medically complex patients commonly seen in clinical practice.
The investigators emphasized the need for prospective trials to further define fidaxomicin’s role in pediatric CDI, particularly among pediatric patients with comorbidities or high relapse risk. They also noted that treatment strategies and cost may affect accessibility.
The findings suggested fidaxomicin may be a viable treatment option for CDI, especially in pediatric patients with recurrent or refractory disease.
The authors declared no conflicts of interest.
Source: The Journal of Pediatrics
