A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections

PHASE4CompletedINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

May 1, 2017

Primary Completion Date

May 23, 2021

Study Completion Date

June 23, 2021

Conditions
Clostridium Difficile Infection (CDI)
Interventions
DRUG

Fidaxomicin

Eligible patients randomized to receive open-label Fidaxomicin will receive 200 mg twice daily for 10 days or until the end of the duration of concomitant antibiotics exposure, whichever is longer.

DRUG

Vancomycin

Eligible patients randomized to Vancomycin will receive 125 mg orally four times daily for 10 days or until the end of the duration of concomitant antibiotics exposure, whichever is longer.

Trial Locations (2)

48109

University of Michigan, Ann Arbor

48197

St. Joseph Mercy Hospital, Ypsilanti

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

University of Michigan

OTHER

NCT02692651 - A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections | Biotech Hunter | Biotech Hunter