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

NCT04000555 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: Pro00037626
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Clostridium Difficile Infection; Clostridium Difficile Infection Recurrence

Keywords

prophylaxis

Outcome Measures

Primary Outcomes (1)

• Recurrence Rate

  Diagnosis of Clostridium Difficile infection to assess recurrence rates Participants will be called at the completion of systemic antibiotics and 1, 2 and 3 months thereafter to assess for recurrence. If participants were tested for C. difficile at another facility records will be obtained to confirm recurrent infection.

  90 days

Secondary Outcomes (1)

• Risk factors associated clostridium difficile infection recurrences

  Day 0 - data will be collection upon enrollment

Study Arms (2)

Study drug

EXPERIMENTAL

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

Drug: Oral Vancomycin

Placebo

PLACEBO COMPARATOR

Matched placebo twice a day prescribed for the duration of antibiotics

Other: Placebo

Interventions

Oral Vancomycin DRUG

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

Study drug

Placebo OTHER

Matched placebo twice a day prescribed for the duration of antibiotics

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (2)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Infectious Disease Associates of Tampa Bay

Tampa, Florida, 33614, United States

Location

MeSH Terms

Conditions

Clostridium Infections

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Mindy Sampson, DO

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All investigators involved will be masked
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Our primary objective is to determine the effectiveness of vancomycin in preventing recurrent Clostridium Difficile Infection (CDI) compared to placebo. Our secondary objective is to attempt to identify risk factors associated with the development of recurrent CDI. 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. Eligible patient's will be randomized 1:1 double-blinded placebo controlled clinical trial to determine the effectiveness of vancomycin at preventing CDI. The first arm in our study would be the "study drug" which is oral vancomycin. The second arm would be placebo. Patient with a history of CDI admitted to Tampa General Hospital or have been seen at Infectious Disease Associates of Tampa Bay clinics are receiving systemic antibiotics and have a history of at least one episode of CDI that was diagnosed on or after 4/1/2017.

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 27, 2019
• Study Start: September 1, 2019
• Primary Completion: June 11, 2022
• Study Completion: June 11, 2022
• Last Updated: April 21, 2023

Record last verified: 2023-03

Locations

US (2)