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

A Randomized, Double-Blinded Placebo Controlled Study To Determine the Effectiveness of Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (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.

Study Overview

• Status: Terminated
• Conditions: Clostridium Difficile Infection; Clostridium Difficile Infection Recurrence
• Intervention / Treatment: Drug: Oral Vancomycin; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mindy Sampson, DO; Phone Number: 813-384-8270; Email: mindysampson@usf.edu
• Study Contact Backup: Name: Kristen Zeitler, PharmD; Phone Number: 813-384-8270; Email: kzeitler@tgh.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
    • Tampa, Florida, United States, 33614
      • Infectious Disease Associates of Tampa Bay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study drug; Oral vancomycin 125mg twice a day prescribed for the duration of antibiotics	Drug: Oral Vancomycin; Oral vancomycin 125mg twice a day prescribed for the duration of antibiotics
Placebo Comparator: Placebo; Matched placebo twice a day prescribed for the duration of antibiotics	Other: Placebo; Matched placebo twice a day prescribed for the duration of antibiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors associated clostridium difficile infection recurrences	Assess any risk factors associated development of recurrence such as age, number of clostridium difficile infections in the past, what antibiotics the patient has been exposed to, and exposure to proton pump inhibitors	Day 0 - data will be collection upon enrollment

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: Mindy Sampson, DO, University of South Florida

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): June 11, 2022
• Study Completion (Actual): June 11, 2022

Study Registration Dates

• First Submitted: June 17, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: prophylaxis
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Recurrence; Clostridium Infections; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: Pro00037626

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No