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Impact of Oral Antibiotic Treatment on C. Difficile (C-Diff)

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ClinicalTrials.gov Identifier: NCT02057198
Recruitment Status : Completed
First Posted : February 6, 2014
Results First Posted : October 2, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
C. Difficile Diarrhea Enterocolitis Drug: Fidaxomicin Drug: Metronidazole Drug: Vancomycin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Active Comparator: Fidaxomicin
200 mg. 2 times a day for 10 days
Drug: Fidaxomicin
Other Names:
  • Drug class(es): macrolides
  • Dificid

Active Comparator: Metronidazole
500 mg.orally 3 times daily for 10 days
Drug: Metronidazole
Other Names:
  • Drug class(es): amebicides
  • Flagyl
  • Flagyl IV
  • Metro
  • Flagyl ER

Active Comparator: Vancomycin
125 mg. orally 4 times a day for 10 days
Drug: Vancomycin
Other Names:
  • Drug Class:Glycopeptide antibiotics
  • Vancocin HCl Pulvules
  • Vancocin
  • Lyphocin
  • Vancocin HCl




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02057198


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Daniel J Sexton, MD Duke University
  Study Documents (Full-Text)

Documents provided by Duke University:
Study Protocol  [PDF] February 28, 2019
Statistical Analysis Plan  [PDF] October 25, 2018


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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02057198     History of Changes
Other Study ID Numbers: Pro00043361
First Posted: February 6, 2014    Key Record Dates
Results First Posted: October 2, 2019
Last Update Posted: October 2, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Enterocolitis
Anti-Infective Agents
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anti-Bacterial Agents
Metronidazole
Vancomycin
Fidaxomicin
Antibiotics, Antitubercular
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents