Impact of Oral Antibiotic Treatment on C. Difficile

Completed · Phase 4

Conditions studied: C. Difficile, Diarrhea, Enterocolitis

In brief

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).

Key facts

Study ID

NCT02057198

Run by

Duke University

People needed

33

Starts

2014-06-10

Expected to finish

2017-06-27

Last updated by the study team

2019-10-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients with microbiology-proven CDAD
• provides informed consent
• eligible to receive oral antibiotic therapy

You may not qualify if…

• 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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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