Clinical trial NCT04000555: Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI)
Official title: A Randomized, Double-Blinded Placebo Controlled Study To Determine the Effectiveness of Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Clostridium Difficile Infection
Clostridium Difficile Infection Recurrence
Keywords: prophylaxis
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Recurrence Rate
timeFrame: 90 days
Secondary outcomes:
measure: Risk factors associated clostridium difficile infection recurrences
timeFrame: Day 0 - data will be collection upon enrollment
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: Infectious Disease Associates of Tampa Bay
state: Florida
Study officials:
affiliation: University of South Florida
name: Mindy Sampson, DO
role: PRINCIPAL_INVESTIGATOR
References: