Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    130
  • sponsor
    University of South Florida
Updated on 17 November 2021
Accepts healthy volunteers

Summary

The purpose of this study is to gain further knowledge regarding the effectiveness of vancomycin prophylaxis in preventing Clostridium difficile infections in order to guide physicians' practices.

Description

Recurrent Clostridium difficile infection (CDI) is associated with significant morbidity, mortality and health care related costs. Up to 30% of CDI cases recur, resulting in 83,000 cases of recurrent CDI per year in the US. Although agents for primary and secondary prophylaxis for CDI including the use of probiotics, antibiotics, fecal microbiota transplantations, and newer therapies such as bezlotoxumab have been reported, there are no consensus guidelines regarding their use.

In order to understand current practices regarding secondary prophylaxis for CDI, a nationwide survey to assess physician practices regarding secondary prophylaxis for CDI. A total of 246 surveys were completed. Physicians were surveyed from greater than 100 locations. Most providers (N=173, 71%) reported using secondary prophylaxis for CDI prevention. The majority (N=138, 56%) were infectious disease providers. Vancomycin (N=121, 70%) and probiotics (N=114, 66%) were most commonly used for CDI secondary prophylaxis. Of 164 respondents who used secondary prophylaxis, 29.9% (N=49) utilized it for patients with a history of CDI who were receiving antibiotics, while 54.2% (N=89), used prophylaxis for patients with a history of recurrent CDI (more than 2 episodes) receiving antibiotics.

Despite the lack of guideline recommendations or definitive studies to support secondary prophylaxis for CDI, the majority of the physicians who responded to this survey are using secondary prophylaxis to prevent recurrent CDI. The purpose of our study is to determine the effectiveness of secondary prophylaxis with oral vancomycin vs. placebo for the prevention of recurrent clostridium difficile infection.

Details
Condition Clostridium Difficile Infection, Clostridium Difficile Infection Recurrence
Treatment Placebo, Oral Vancomycin
Clinical Study IdentifierNCT04000555
SponsorUniversity of South Florida
Last Modified on17 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients admitted to Tampa General Hospital or outpatients at Infectious Disease Associates of Tampa Bay clinics who are receiving systemic antibiotics and have a history of at least one episode of CDI
Participants must at least 18 years of age to participate
Participants must be able to understand and sign a written informed consent form prior to initiation of study procedures
Expected to receive at least 3 days of systemic antibiotics
Life expectancy greater than 6 months

Exclusion Criteria

Current CDI
Completion of treatment for CDI within the last 15 days
Concurrent use of drugs that have activity against C. difficile such as metronidazole, fidaxomicin, nitazoxanide, tigecycline, or rifaximine
Concurrent use of cholestyramine
Concurrent use of bezlotoxumab
Concurrent use of probiotics
Concurrent use of Imodium or other antidiarrheal agents
Chronic suppressive antibiotics
Condition which causes chronic diarrhea such as inflammatory bowel disease
Bacterial gastroenteritis other than CDI
Pregnancy or breastfeeding
Allergy to oral Vancomycin
Inability to take enteric medications
Have an unstable or life limiting condition on admission
Already participating in another study
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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