Clostridioides difficile: Examining Bezlotoxumab and Fecal Microbiota Transplantation

Publication
Article
Infection Control TodayInfection Control Today, April 2023, (Vol. 27, No. 3)
Volume 27
Issue 3

These treatments were reviewed in a real-world application to evaluate their effectiveness in preventing recurrences.

Clostridioides difficile infections (CDI)

Clostridioides difficile infections (CDI)

(Adobe Stock)

This article first appeared on ContagionLive.com.

With newer modalities and therapies for Clostridioides difficile infections (CDI) coming online, there is a need for more studies and an understanding of where they are best applied in the clinical setting.

Real-world application of the human monoclonal antibody bezlotoxumab (Zinplava), and the modality of fecal microbiota transplantation (FMT), has been limited to a few factors, including treatment guidelines, therapy cost, and the availability of the modality.

Investigators wanted to explore using both to evaluate the efficaciousness of bezlotoxumab (BZX) and FMT in preventing early (within 8 weeks) and late (within 1 year) CDI recurrences (rCDI).

This was a retrospective study conducted in a Spanish university hospital from January 2018 to April 2021. All adult patients with confirmed CDI were prospectively included in a database. Patients who received BZX or FMT during this period were selected. A follow-up appointment of at least 8 weeks was required, so cases for which there were no follow-up data were excluded.

The study included 100 CDI episodes for analysis, with 51 cases treated with bezlotoxumab and 49 with FMT.

The study was published in the Open Forum Infectious Diseases.

What the Data Shows
The monoclonal antibody was primarily used in immunosuppressed patients (66.7%) and in first episodes or first recurrences (70.6%). FMT was prescribed only in CDI recurrences.

Bezlotoxumab. In October 2016, bezlotoxumab was FDA-approved and indicated for treatment against C difficile toxin B for the prevention of CDI recurrence. In this study, the therapy was administered on first episodes in 35.3%, on first recurrences in 35.3%, and on second or further recurrences in 29.4%, according to the investigators. Of these, 45.0% of the CDI episodes were clinically severe.

Regarding the outcome, there were 10 (19.6%) early recurrences within 8 weeks and 5 (9.8%) late CDI episodes within 1 year of follow-up. The mortality rate was 7.8% in the first 8-week period and 27.5% in the 1-year follow-up period. None of the deaths were CDI related.

FMT. At the hospital where the study was conducted, FMT was performed with lyophilized oral capsules. Patients received a single dose of FMT after completing a course of oral vancomycin or fidaxomicin to treat a CDI episode. The treatment selection in each case was decided according to local guidelines and per the advice of infectious diseases specialists and the pharmacy department, according to the investigators.

“Despite the different conditions of the patients, there were no significant differences between BZX and FMT in preventing early rCDI (19.6% vs 24.5%; P = .55) or late rCDI (9.8% vs 18.4%; P = .31). In the multivariate analysis, risk factors for recurrence were the presence of [greater than or equal to] 2 previous rCDI episodes (odds ratio [OR], 2.90; 95% CI, 1.03–8.63) and use of non-CDI antibiotics (OR, 3.45; 95% CI, 1.24–9.57),” they wrote.

“Both treatments had similar effectiveness in preventing CDI recurrence despite their application to different populations.”

Regarding limitations, the investigators noted a few things, including that this was a retrospective study, the heterogeneity of patients, and a small number of patients. Nonetheless, they pointed out that this has been one of the most extensive studies comparing these treatment approaches.

The investigators noted a few conclusions from their study. “BZX and FMT were infrequently used in real-world practice (8.5% in our series) and in very different clinical scenarios, as BZX was more frequently assigned to patients with immunosuppression and for first and severe episodes, while FMT was indicated in cases with several prior CDI recurrences. Second, despite these differences, both strategies of treatment had equivalent effectiveness, assessed in terms of early and late rCDI episodes. Third, BZX and FMT appeared to be more effective in the treatment of first recurrences compared with second or further rCDI episodes.”

Recent Videos
Andrea Flinchum, 2024 president of the Certification Board of Infection Control and Epidemiology, Inc (CBIC) explains the AL-CIP Certification at APIC24
Association for Professionals in Infection Control and Epidemiology  (Image credit: APIC)
Lila Price, CRCST, CER, CHL, the interim manager for HealthTrust Workforce Solutions; and Dannie O. Smith III, BSc, CSPDT, CRCST, CHL, CIS, CER, founder of Surgicaltrey, LLC, and a central processing educator for Valley Health System
Jill Holdsworth, MS, CIC, FAPIC, CRCSR, NREMT, CHL, and Katie Belski, BSHCA, CRCST, CHL, CIS
Baby visiting a pediatric facility  (Adobe Stock 448959249 by Rawpixel.com)
Antimicrobial Resistance (Adobe Stock unknown)
Anne Meneghetti, MD, speaking with Infection Control Today
Patient Safety: Infection Control Today's Trending Topic for March
Infection Control Today® (ICT®) talks with John Kimsey, vice president of processing optimization and customer success for Steris.
Related Content