Vancomycin as Secondary Prophylaxis to Prevent Recurrent C diff Infection
2 CDI recurrences occurred in this study, both in placebo recipients who were immunocompromised.
Clostridioides difficile (C diff) can cause severe, debilitating, and even fatal gastrointestinal infection, and this pathogenesis worsens with each recurrent C diff infection (CDI). Up to 30% of CDI cases are recurrent, causing a significant strain on patients and health care systems.
Many agents have been utilized for primary and secondary CDI prophylaxis, including probiotics, fecal microbiota transplantation (FMT), and monoclonal antibodies. In particular, the tricyclic glycopeptide antibiotic vancomycin is often used to treat and prevent Gram-positive bacterial infections.
Oral vancomycin 125 mg daily is recommended as secondary prophylaxis in individuals who are receiving systemic antibiotics, with a history of severe CDI within the past 3 months, who are either 65 years and older or severely immunocompromised. However, all data supporting vancomycin as secondary CDI prophylaxis is retrospective.
A team of investigators, led by USF Health and Tampa General Hospital, conducted a prospective study to determine the effectiveness of vancomycin in preventing recurrent CDI (rCDI) compared to placebo.
This randomized, double-blind, placebo-controlled trial was presented by author Mindy Sampson, DO, during a poster session at the Society for Healthcare Epidemiology of America (SHEA) 2023 Spring Conference. The study was conducted at Tampa General Hospital, a level 1 trauma center with over 1000 beds that performs solid organ transplants.
From October 2019-September 2022, the investigators enrolled patients who had a history of at least 1 episode of CDI and were receiving systemic antibiotics for at least 3 days for an unrelated condition.
Patients were excluded if they had a current CDI, had completed treatment for CDI within the last 15 days, were currently on drugs with activity against C diff, were taking chronic suppressive antibiotics, had a condition that caused chronic diarrhea, had bacterial gastroenteritis other than CDI, were pregnant or breastfeeding, were allergic to vancomycin, had an inability to take enteric medications, had an unstable or life limiting condition on hospital admission, had a life expectancy of fewer than 6 months, and/or were already participating in another study.
To assess for CDI recurrence, the participants were interviewed over the phone at 1, 2, and 3 months. A total of 26 patients were originally enrolled, but only 11 completed all interviews. A total of 11 participants were included in the final analyses, with 4 randomized to oral vancomycin 125 mg twice daily, and 7 randomized to placebo.
The 11 participants averaged 63% female, with 45% over 65 years of age and 45% immunocompromised. Additionally, 36% had a primary CDI less than a year before study enrollment and the remaining 64% had their primary CDI more than a year prior to enrollment.
One case of recurrent CDI was reported at the 1-moth interview, and a second was reported at 3 months; both cases occurred in placebo recipients, and both individuals were immunocompromised. One recurrence occurred in an African American participant living with HIV, and the other in a Hispanic participant who had undergone a heart and kidney transplant.
The study was terminated early due to low enrollment, with the most common reasons for study dropout including participant discharge to a facility where vancomycin could not be given and an inability to reach participant for follow-up interviews.
Although the relatively small sample size inhibits statistical significance, these study results suggest secondary prophylaxis with oral vancomycin may benefit patients who are actively receiving antibiotics. The study authors noted that the introduction and approval of new CDI preventative agents, such as Rebyota (RBX2660; fecal microbiota, live-jlsm), may make it even more difficult to conduct prospective trials to evaluate the efficacy of vancomycin as secondary CDI prophylaxis.
This study was presented during a poster session at the Society for Healthcare Epidemiology of America (SHEA) 2023 Spring Conference.
