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Observational Study
. 2025 Oct:285:114681.
doi: 10.1016/j.jpeds.2025.114681. Epub 2025 Jun 6.

Fidaxomicin Treatment of Clostridioides difficile Infections and Recurrences in Children and Adolescents: A Retrospective Multicenter Study

Máire A Conrad  1 , Abby L Kaplan  2 , Sarah Weinbrom  3 , Silvia Nastasio  4 , Diana Jo  5 , Katie Conover  6 , Kathleen Lo  7 , Enju Liu  8 , Melissa Crawford  9 , Sonia Michail  7 , Maribeth Nicholson  10 , Suchitra K Hourigan  11 , Judith R Kelsen  9 , Stacy A Kahn  12
Affiliations
Observational Study

Fidaxomicin Treatment of Clostridioides difficile Infections and Recurrences in Children and Adolescents: A Retrospective Multicenter Study

Máire A Conrad et al. J Pediatr. 2025 Oct.

Abstract

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.

Keywords: children; colitis; dysbiosis; fecal microbiota transplantation.

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Conflict of interest statement

Declaration of Competing Interest This work was supported by a National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) grant K23119585 to MAC, National Institute of Allergy, and Infectious Diseases (NIAID) grant K23AI156132 to MRN; National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health under the Division of Intramural Research, NIAID, NIH to SKH, and Cures within Reach (SAK). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. M.A.C. reports financial support was provided by National Institutes of Health. M.N. reports financial support was provided by National Institutes of Health National Institute of Allergy and Infectious Diseases. S.H. reports financial support was provided by National Institutes of Health. S.A.K. reports financial support was provided by Cures Within Reach. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figure 1:
Figure 1:
Flow chart of included patients with C. difficile infection treated with fidaxomicin and outcomes at T1 Day 14 and T2 Day 60. T2 outcomes were limited to 79 patients with initial cure or response to fidaxomicin at T1. Clinical recurrence at T2 included patients with symptoms and positivity on re-testing for C. difficile/toxin. No clinical recurrence included patients with no recurrence of symptoms plus those with recurrence of symptoms and negative C. difficile re-testing or no re-testing.
See this image and copyright information in PMC

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