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Fidaxomicin Treatment of Clostridioides difficile Infections and Recurrences in Children and Adolescents: A
Máire A Conrad1, Abby L Kaplan2, Sarah Weinbrom3
1Division of Pediatric Gastroenterology, Hepatology, and Nutrition, The Children's Hospital of Philadelphia, Philadelphia, PA; Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
Insights
Fidaxomicin effectively treats children with Clostridioides difficile infection (CDI), showing good tolerability and low failure rates in a real-world setting. This study highlights its potential for managing both primary and recurrent CDI in pediatric patients.
Area of Science:
- Pediatric Infectious Diseases
- Microbiology
- Clinical Pharmacology
Background:
- Clostridioides difficile infection (CDI) poses a significant challenge in pediatric populations, with increasing rates of recurrence.
- Limited real-world data exists on the effectiveness and tolerability of fidaxomicin in children with CDI.
Purpose of the Study:
- To evaluate the real-world effectiveness and tolerability of fidaxomicin in treating primary and recurrent CDI in children.
- To assess clinical and microbiologic outcomes in pediatric patients receiving fidaxomicin.
Main Methods:
- A multicenter, retrospective, observational study was conducted involving children aged 12 months to 18 years treated with fidaxomicin for CDI between 2013 and 2021.
- Clinical response was assessed at day 14, and clinical and microbiologic outcomes were evaluated at day 60 post-treatment initiation in initial responders.
Main Results:
- Of 95 pediatric patients, 88.4% had recurrent CDI and 86.3% had comorbidities. Clinical cure or improvement was observed in 83.1% by day 14.
- Among initial responders, 21.5% experienced clinical and microbiologic recurrence by day 60.
- Patients with inflammatory bowel disease showed lower initial cure rates but no increased risk of later recurrence. Abdominal pain and nausea were the most common adverse events.
Conclusions:
- Fidaxomicin is well-tolerated and demonstrates a low rate of treatment failure in children with CDI in a real-world setting.
- The drug shows promise for managing both primary and recurrent CDI in pediatric patients, including those with comorbidities.
Objective:
To report the effectiveness and tolerability of treating children with primary and recurrent Clostridioides difficile infection (CDI) with fidaxomicin in a real-world, multicenter cohort.
Study Design:
We performed a multicenter, retrospective, observational study of fidaxomicin treatment for primary or recurrent CDI in children ages 12 months to 18 years old identified from 2013 to 2021 at 5 centers via electronic medical records. Outcomes included assessment of clinical response at day 14 after initiation of fidaxomicin treatment and clinical and microbiologic outcomes at day 60 after initiation of fidaxomicin treatment in the initial responders.
Results:
Of the 95 patients included in this study, 84 (88.4%) were treated with fidaxomicin for a recurrent CDI, and 82 (86.3%) had at least one medical or surgical comorbidity. At the completion of fidaxomicin treatment (ie, by day 14 after initiation), 50 patients (52.6%) had a clinical cure and an additional 29 (30.5%) had improvement of symptoms. Among 79 patients who responded to fidaxomicin treatment, 17 (21.5%) had a clinical and microbiologically confirmed recurrence of CDI by day 60, likely representing relapse. Patients with inflammatory bowel disease were less likely to achieve clinical cure at day 14 (OR 0.27 (95% CI 0.11, 0.70)), but 20 patients with inflammatory bowel disease who had initial clinical cure or response did not have a demonstrable increased risk of recurrence at day 60. The most common adverse events reported during therapy were abdominal pain and nausea.
Conclusions:
In this retrospective, real-world study, fidaxomicin for children with CDI appears to be well tolerated and is associated with low rates of treatment failure.
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