Impact of Oral Antibiotic Treatment on C. Difficile (C-Diff)
|ClinicalTrials.gov Identifier: NCT02057198|
Recruitment Status : Completed
First Posted : February 6, 2014
Results First Posted : October 2, 2019
Last Update Posted : October 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|C. Difficile Diarrhea Enterocolitis||Drug: Fidaxomicin Drug: Metronidazole Drug: Vancomycin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||June 10, 2014|
|Actual Primary Completion Date :||June 27, 2017|
|Actual Study Completion Date :||June 27, 2017|
Active Comparator: Fidaxomicin
200 mg. 2 times a day for 10 days
Active Comparator: Metronidazole
500 mg.orally 3 times daily for 10 days
Active Comparator: Vancomycin
125 mg. orally 4 times a day for 10 days
- Change in Total Median Total Colony Forming Units (CFU) of C. Difficile Identified in the Hospital Room Environment for Each Antibiotic Treatment Group. [ Time Frame: Days 0, 3, 7 and 14. ]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.
- Total Environmental Contamination According to Antibiotic Treatment Group [ Time Frame: Days 0, 3, 7, and 14 ]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.
- Molecular Relatedness of Isolates [ Time Frame: Days 0-14 ]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).
- C. Difficile Shedding in Stool Over Time [ Time Frame: Days 0, 3, 7, 14 ]C. difficile was isolated and serially diluted to permit colony counts (CFU/g stool) over time for each patient.
- Count of Stool Specimens From Patients That Are Positive for C. Difficile [ Time Frame: Days 0, 3, 7, 14 ]Count of stool cultures positive for C. difficile at each time point
- Percentage of Stool Specimens From Patients That Are Positive for C. Difficile [ Time Frame: Days 0, 3, 7, 14 ]Percentage of stool cultures positive for C. difficile at each time point
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057198
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Daniel J Sexton, MD||Duke University|