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. 2021 Jan 14:9:2050312120986733.
doi: 10.1177/2050312120986733. eCollection 2021.

Clinical complications in patients with primary and recurrent Clostridioides difficile infection: A real-world data analysis

Paul Feuerstadt  1   2 , Mena Boules  3 , Laura Stong  3 , David N Dahdal  3 , Naomi C Sacks  4   5 , Kathleen Lang  4 , Winnie W Nelson  3
Affiliations

Clinical complications in patients with primary and recurrent Clostridioides difficile infection: A real-world data analysis

Paul Feuerstadt et al. SAGE Open Med. .

Abstract

Objective: Clostridioides difficile infection and recurrent C. difficile infection result in substantial economic burden and healthcare resource use. Sepsis and bowel surgery are known to be serious complications of C. difficile infection. This study evaluated clinical complications in patients with C. difficile infection and recurrent C. difficile infection during a 12-month period following the primary C. difficile infection.

Methods: A retrospective analysis of commercial claims data from the IQVIA PharMetrics Plus™ database was conducted for patients aged 18-64 years with an index C. difficile infection episode requiring inpatient stay or an outpatient visit for C. difficile infection followed by a C. difficile infection treatment. Each C. difficile infection episode ended after a 14-day C. difficile infection-claim-free period was observed. Recurrent C. difficile infection was defined as a further C. difficile infection episode within an 8-week window following the claim-free period. Clinical complications were documented over 12 months of follow-up and stratified by the number of recurrent C. difficile infection episodes (0 rCDI, 1 rCDI, 2 rCDI, and 3+ rCDI).

Results: In total, 46,571 patients with index C. difficile infection episode were included. During the 6-month pre-index, the mean (standard deviation) baseline Charlson comorbidity index score, by increasing the recurrent C. difficile infection group, was 1.2 (1.9), 1.5 (2.2), 1.8 (2.3), and 2.3 (2.5). During the 12-month follow-up, sepsis occurred in 16.5%, 27.3%, 33.1%, and 43.3% of patients, and subtotal colectomy or diverting loop ileostomy was performed in 4.6%, 7.3%, 8.9%, and 10.5% of patients, respectively, by increasing the recurrent C. difficile infection group.

Conclusions: Reduction in recurrent C. difficile infection is an important step to reduce the burden of serious clinical complications, and new treatments are needed to reduce C. difficile infection recurrence.

Keywords: Clostridioides difficile infection; Clostridium difficile infection; real-world analysis; recurrent Clostridioides difficile infection; sepsis.

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Conflict of interest statement

Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: M.B., L.S., W.W.N., and D.N.D. are employees of Ferring Pharmaceuticals, Inc. P.F. has served as a consultant to and on the speaker’s bureau for Merck and Co and has served as a consultant for Ferring Pharmaceuticals, Inc. and Roche Pharmaceuticals. N.C.S. and K.L. are employees of Precision Health Economics and Outcomes Research and provided consulting services to Ferring Pharmaceuticals, Inc.

Figures

Figure 1.
Figure 1.
Study design: (a) the index CDI episode was followed by a 14-day claim-free period after last CDI claim and an 8-week period to identify rCDI and (b) the red star indicates a hypothetical point at which the first rCDI episode occurs during the 8-week window after the claim-free period. Following this first rCDI episode, a new 14-day claim-free period occurs plus a new window for a subsequent rCDI episode. Multiple rCDI could occur after an index CDI event in this manner, up until 12 months following the index CDI date.
Figure 2.
Figure 2.
Vancomycin was the most commonly prescribed antibiotic to treat the first, second, and third rCDI episodes, followed by metronidazole and then fidaxomicin.
Figure 3.
Figure 3.
Rates of (a) sepsis and (b) subtotal colectomy or diverting loop ileostomy during the 12 months after index CDI, by recurrence cohort.
See this image and copyright information in PMC

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