A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02692651|
Recruitment Status : Recruiting
First Posted : February 26, 2016
Last Update Posted : May 3, 2018
Administration of concomitant antibiotics (CA) is a known risk factor for treatment failure in the treatment of CDI, as well as for recurrence of CDI. Recent data suggested that among patients receiving CA, fidaxomicin is superior vancomycin. While these data are encouraging, many clinicians remain unclear on how to apply these data to patient care. Additionally, patients were excluded from the trials presented to the FDA if it was expected that they would require ≥ 7 days of CA. Therefore, the clinical question still remains of how to apply these data to the real world patient who requires a long course of CA and develops CDI while on therapy. We therefore propose an open label, comparative and prospective study of fidaxomicin 200 mg twice daily vs oral vancomycin 125 mg four times daily for the treatment of CDI among patients who are receiving a long course of CA.
We hypothesize that fidaxomicin will be superior to vancomycin with respect to clinical cure for patients with CDI.
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection (CDI)||Drug: Fidaxomicin Drug: Vancomycin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Comparison of Fidaxomicin and Oral Vancomycin for the Treatment of Clostridium Difficile Infection (CDI) in Hospitalized Patients Receiving Concomitant Antibiotics for the Treatment of Concurrent Systemic Infections|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||April 2020|
Active Comparator: Fidaxomicin
Fidaxomicin 200 mg PO BID for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
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.
Other Name: Vancocin
Active Comparator: Vancomycin
Vancomycin 125 mg PO QID for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
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.
Other Name: Dificid, Dificlir, OPT-80, PAR-101
- Clinical Cure: Resolution of diarrhea [ Time Frame: Up to 28 days ]Resolution of diarrhea defined as ≤ 3 unformed stools for 2 consecutive days maintained until the end of therapy, which is 10 days, and for 2 days afterwards.
- Recurrence of CDI [ Time Frame: 42 days ]Recurrence is defined as all three of the following within 4 weeks after successfully completing study treatment: reappearance of symptoms of CDI (>3 unformed stools in a 24 hour period; a positive stool PCR test for C. difficile; and the need for retreatment with an agent active against C. difficile).
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): NCT02692651
|Contact: Jolene Danielfirstname.lastname@example.org|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48091|
|Contact: Keith S Kaye, MD 734-615-1901 email@example.com|
|Contact: Jolene Daniel 734-615-1901 firstname.lastname@example.org|
|Principal Investigator:||Keith Kaye, MD, MPH||University of Michigan|