Oral Vancomycin for Secondary Prophylaxis of Clostridium... | NCT04000555

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

NCT04000555

Sponsor

University of South Florida

Status

Terminated

Last Update Posted

Apr 21, 2023Actual

Enrollment

26Actual

Phase

Phase 4

Conditions

Clostridium Difficile Infection
Clostridium Difficile Infection Recurrence

Interventions

Oral Vancomycin
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was terminated early due to low enrollment, this was partially related to our ability to recruit during the COVID-19 pandemic.

Expanded Access Info

Start Date

Sep 1, 2019Actual

Primary Completion Date

Jun 11, 2022Actual

Completion Date

Jun 11, 2022Actual

First Submitted Date

Jun 17, 2019

First Submission Date that Met QC Criteria

Jun 24, 2019

First Posted Date

Jun 27, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2023

Last Update Posted Date

Apr 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Oral Vancomycin	Drug	Oral vancomycin 125mg twice a day prescribed for the duration of antibiotics	Study drug

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Mindy Sampson, DO	University of South Florida	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Tampa General Hospital		Tampa	Florida	33606	United States
Infectious Disease Associates of Tampa Bay

Condition Browse Module

MeSH Terms

ID	Term
D003015	Clostridium Infections

Ancestor Terms

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D014640	Vancomycin

ID	Term
D006020	Glycopeptides
D006001	Glycoconjugates
D002241	Carbohydrates
D010455	Peptides

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.