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

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of South Florida
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Vancomycin

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