Diarrhea Clinical Trial
— C-DiffOfficial title:
Exploratory Study of Impact of Oral Metronidazole, Vancomycin and Fidaxomicin on the Extent and Quantity of Host Carriage and Environmental Contamination With C. Difficile
Verified date | September 2019 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overall aim is to characterize and to compare the extent and quantity of C. difficile stool shedding, perianal colonization and environmental contamination in patients who received oral fidaxomicin, oral metronidazole, or oral vancomycin. This is a prospective, randomized, microbiologic and molecular, study of environmental contamination from patients with proven C. difficile associated diarrhea (CDAD).
Status | Completed |
Enrollment | 33 |
Est. completion date | June 27, 2017 |
Est. primary completion date | June 27, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - adult patients with microbiology-proven CDAD - provides informed consent - eligible to receive oral antibiotic therapy Exclusion Criteria: - prisoners - pregnant women - children <18 years - patients who have contra-indications for perianal swabs, those who has medical conditions that would invalidate the results of the swabs - patients requiring intravenous therapy for treatment of CDAD - patients who do not consent and those who withdraw consent |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Total Median Total Colony Forming Units (CFU) of C. Difficile Identified in the Hospital Room Environment for Each Antibiotic Treatment Group. | Rodac plates were used to take environmental samples from 5 different sites within each patient's hospital room (bedrail, overbed table, sink, toilet seat, bathroom floor). Each Rodac plate samples a surface area of ~25 cm2. 5 replicates were taken for each site and repeated on days 0, 3, 7, and 14. Median total colony counts are reported for each treatment group. Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models. | Days 0, 3, 7 and 14. | |
Secondary | Total Environmental Contamination According to Antibiotic Treatment Group | In addition to total colony counts over time, the investigators also assessed the proportion of positive cultures over time (from the 5 replicate Rodac plate samplings repeated at each of 5 sites within each patient room: bedrail, overbed table, sink, toilet seat and bathroom floor). The cumulative proportion of positive cultures (including days 0, 3, 7, 14) is reported according to each treatment group. | Days 0, 3, 7, and 14 | |
Secondary | Molecular Relatedness of Isolates | When sufficient growth was available to permit sub-culture and ribotyping, we conducted ribotyping of each patient's stool C. difficile isolate for comparison to isolates from the same patient's hospital environment. Reported is the total percent of hospital room environmental isolates that match the ribotyping of the associated patient's stool sample (there is no averaging). | Days 0-14 | |
Secondary | C. Difficile Shedding in Stool Over Time | C. difficile was isolated and serially diluted to permit colony counts (CFU/g stool) over time for each patient. | Days 0, 3, 7, 14 | |
Secondary | Count of Stool Specimens From Patients That Are Positive for C. Difficile | Count of stool cultures positive for C. difficile at each time point | Days 0, 3, 7, 14 | |
Secondary | Percentage of Stool Specimens From Patients That Are Positive for C. Difficile | Percentage of stool cultures positive for C. difficile at each time point | Days 0, 3, 7, 14 |
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