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C. Difficile | Impact of Oral Antibiotic Treatment on C. Difficile

C. Difficile research study

What is the primary objective of this study?

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).

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

C. Difficile

Diarrhea

Enterocolitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Fidaxomicin

Drug:Metronidazole

Drug:Vancomycin

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Fidaxomicin200 mg. 2 times a day for 10 days

Metronidazole500 mg.orally 3 times daily for 10 days

Vancomycin125 mg. orally 4 times a day for 10 days

Study Status

Completed

Start Date: June 10, 2014

Completed Date: June 27, 2017

Phase:

Type: Observational

Design:

Primary Outcome: Change in variation of the profile of C. difficile isolated from specific body sites of a patient with microbiology-proven CDAD

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Luke Chen, MBBS,MPH

Lead Sponsor: Duke University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02057198

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