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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Clostridium Difficile Infection, Clostridium Difficile Infection Recurrence

In brief

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.

Key facts

Study ID

NCT04000555

Run by

University of South Florida

People needed

26

Starts

2019-09-01

Expected to finish

2022-06-11

Last updated by the study team

2023-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Tampa General Hospital — Tampa, Florida, United States
• Infectious Disease Associates of Tampa Bay — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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