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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04000555
Other study ID # Pro00037626
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date September 1, 2019
Est. completion date June 11, 2022

Study information

Verified date March 2023
Source University of South Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 26
Est. completion date June 11, 2022
Est. primary completion date June 11, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Oral Vancomycin
Oral vancomycin 125mg twice a day prescribed for the duration of antibiotics
Other:
Placebo
Matched placebo twice a day prescribed for the duration of antibiotics

Locations

Country Name City State
United States Infectious Disease Associates of Tampa Bay Tampa Florida
United States Tampa General Hospital Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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