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

NCT ID: NCT04000555

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2022-06-11

Brief 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.

Detailed 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.

Conditions

Clostridium Difficile Infection; Clostridium Difficile Infection Recurrence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Study drug

Oral vancomycin 125mg twice a day prescribed for the duration of antibiotics

Group Type: EXPERIMENTAL

Oral Vancomycin

Intervention Type: DRUG

Oral vancomycin 125mg twice a day prescribed for the duration of antibiotics

Placebo

Matched placebo twice a day prescribed for the duration of antibiotics

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matched placebo twice a day prescribed for the duration of antibiotics

Interventions

Oral Vancomycin

Oral vancomycin 125mg twice a day prescribed for the duration of antibiotics

Intervention Type: DRUG

Placebo

Matched placebo twice a day prescribed for the duration of antibiotics

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mindy Sampson, DO

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

Tampa General Hospital

Tampa, Florida, United States

Infectious Disease Associates of Tampa Bay

Tampa, Florida, United States

Countries

United States

Other Identifiers

Pro00037626

Identifier Type: -

Identifier Source: org_study_id