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Trial record 91 of 528 for:    VANCOMYCIN

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

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ClinicalTrials.gov Identifier: NCT04000555
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of South Florida

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.

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Clostridium Difficile Infection Recurrence Drug: Oral Vancomycin Other: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All investigators involved will be masked
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blinded Placebo Controlled Study To Determine the Effectiveness of Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI)
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Recurrence Rate [ Time Frame: 90 days ]

    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.



Secondary Outcome Measures :
  1. Risk factors associated clostridium difficile infection recurrences [ Time Frame: Day 0 - data will be collection upon enrollment ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 that was diagnosed on or after 4/1/2017.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000555


Contacts
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Contact: Andrew Nguyen, MD 813-384-8270 andrewnguye@health.usf.edu
Contact: Mindy Sampson, DO 813-384-8270 mindysampson@health.usf.edu

Locations
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United States, Florida
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Andrew Nguyen, MD    813-384-8270    AndrewNguye@health.usf.edu   
Contact: Mindy Sampson, DO    813-384-8270    Mindysampson@health.usf.edu   
Sub-Investigator: Cynthia Mayer, DO         
Sub-Investigator: Seetha Lakshmi, MD         
Sub-Investigator: Sally Alraaba, MD         
Sub-Investigator: Zeitler Kristen, PharmD         
Sub-Investigator: Jariwala Ripal, PharmD         
Infectious Disease Associates of Tampa Bay Recruiting
Tampa, Florida, United States, 33614
Contact: Andrew Nguyen, MD    813-384-8270    Andrewnguye@health.usf.edu   
Contact: Cynthia Mayer, DO         
Sponsors and Collaborators
University of South Florida
Investigators
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Principal Investigator: Mindy Sampson, DO University of South Florida

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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT04000555     History of Changes
Other Study ID Numbers: Pro00037626
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: June 2019

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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
Keywords provided by University of South Florida:
prophylaxis
Additional relevant MeSH terms:
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Vancomycin
Infection
Communicable Diseases
Clostridium Infections
Recurrence
Disease Attributes
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents