Back to resultsOral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics
Primary Purpose
Clostridium Difficile Infection
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oral Vancomycin
Sponsored by
About this trial
This is an interventional prevention trial for Clostridium Difficile Infection focused on measuring vancomycin, Clostridium difficile, Clostridium difficile infection, Recurrent Clostridium difficile infection
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years
- Previous CDI diagnosis
- Current admission with a suspected or a confirmed bacterial infection requiring antibiotics
Exclusion Criteria:
- Active chronic diarrheal illness (eg, Crohn's disease, ulcerative colitis, short bowel syndrome)
- Previous adverse reactions to oral vancomycin
- Requiring metronidazole during hospitalization
- Known pregnancy
- Expected survival <72 hours
- Patients receiving antibiotics only for surgical prophylaxis
- Patients who received prophylactic oral vancomycin for the current antibiotic course prior to enrollment in the study
Sites / Locations
- Renown Regional Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
No oral vancomycin
Oral vancomycin 125 mg twice daily
Oral vancomycin 125 mg daily
Arm Description
Outcomes
Primary Outcome Measures
Recurrent Clostridium difficile infection
Diarrheal illness, with at least 3 episodes of watery diarrhea over a 24 hour period and a positive toxin analysis or a positive PCR for Cdiff
Secondary Outcome Measures
Recurrence rate of CDI according to C diff inducing properties of the prescribed antibiotics
Low inducers: aminoglycosides, fosfomycin, glycopeptides, daptomycin, nitrofurantoin, linezolid, polymyxins, rifamycins, antifolates and/or sulfonamides, tetracyclines, tigecycline
Moderate inducers: penicillins, 1st generation cephalosporins, macrolides, azithromycin, streptogramins
High inducers: carbapenems, 2nd and greater generation cephalosporins, fluoroquinolones, clindamycin
Time between recurrent CDI and the last C diff infection
Rate of recurrence of CDI in immunocompromised patients
HIV, Organ Transplantation, Current Immunosuppressive therapy, Hypogammaglobulinemia or steroids dose more than prednisone 20mg/day for 3 weeks
Rate of recurrence of CDI in patients with a history of the NAP-1 strain
Rate of reported adverse events
Mortality rate
Full Information
NCT ID
NCT03466502
First Posted
March 8, 2018
Last Updated
December 9, 2020
Sponsor
University of Nevada, Reno
Collaborators
Renown Regional Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03466502
Brief Title
Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics
Official Title
Efficacy of Prophylactic Oral Vancomycin in Preventing Recurrent Clostridium Difficile Infection in Hospitalized Patients Requiring Antibiotics
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 8, 2018 (Actual)
Primary Completion Date
February 13, 2021 (Anticipated)
Study Completion Date
February 13, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nevada, Reno
Collaborators
Renown Regional Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent Clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection.
Detailed Description
This study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent Clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection
Keywords
vancomycin, Clostridium difficile, Clostridium difficile infection, Recurrent Clostridium difficile infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No oral vancomycin
Arm Type
No Intervention
Arm Title
Oral vancomycin 125 mg twice daily
Arm Type
Experimental
Arm Title
Oral vancomycin 125 mg daily
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oral Vancomycin
Intervention Description
Oral vancomycin will be given concurrently with antibiotics to hospitalized patients with a history of Clostridium difficile infection to prevent recurrence
Primary Outcome Measure Information:
Title
Recurrent Clostridium difficile infection
Description
Diarrheal illness, with at least 3 episodes of watery diarrhea over a 24 hour period and a positive toxin analysis or a positive PCR for Cdiff
Time Frame
During hospitalization or the 12 weeks after therapy
Secondary Outcome Measure Information:
Title
Recurrence rate of CDI according to C diff inducing properties of the prescribed antibiotics
Description
Low inducers: aminoglycosides, fosfomycin, glycopeptides, daptomycin, nitrofurantoin, linezolid, polymyxins, rifamycins, antifolates and/or sulfonamides, tetracyclines, tigecycline
Moderate inducers: penicillins, 1st generation cephalosporins, macrolides, azithromycin, streptogramins
High inducers: carbapenems, 2nd and greater generation cephalosporins, fluoroquinolones, clindamycin
Time Frame
During hospitalization or the 12 weeks after therapy
Title
Time between recurrent CDI and the last C diff infection
Time Frame
During hospitalization or the 12 weeks after therapy
Title
Rate of recurrence of CDI in immunocompromised patients
Description
HIV, Organ Transplantation, Current Immunosuppressive therapy, Hypogammaglobulinemia or steroids dose more than prednisone 20mg/day for 3 weeks
Time Frame
During hospitalization or the 12 weeks after therapy
Title
Rate of recurrence of CDI in patients with a history of the NAP-1 strain
Time Frame
During hospitalization or the 12 weeks after therapy
Title
Rate of reported adverse events
Time Frame
During hospitalization or the 12 weeks after therapy
Title
Mortality rate
Time Frame
During hospitalization or the 12 weeks after therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years
Previous CDI diagnosis
Current admission with a suspected or a confirmed bacterial infection requiring antibiotics
Exclusion Criteria:
Active chronic diarrheal illness (eg, Crohn's disease, ulcerative colitis, short bowel syndrome)
Previous adverse reactions to oral vancomycin
Requiring metronidazole during hospitalization
Known pregnancy
Expected survival <72 hours
Patients receiving antibiotics only for surgical prophylaxis
Patients who received prophylactic oral vancomycin for the current antibiotic course prior to enrollment in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Zion, PharmD
Organizational Affiliation
Renown Regional Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics
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