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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. Identifier: NCT02692651
Recruitment Status : Recruiting
First Posted : February 26, 2016
Last Update Posted : April 24, 2020
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Keith Kaye, University of Michigan

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
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.
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.
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.
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.
Other Name: Dificid, Dificlir, OPT-80, PAR-101

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients 18 years of age or older with >3 unformed stools/24 hours with positive stool test for C. difficile.
  • Patients receiving ≥ 1 high or medium risk antibiotic for treatment of an infection other than CDI, for an anticipated duration of ≥ 5 days from the time of enrollment.

Exclusion Criteria:

  • Patients with severe-complicated disease that would compromise oral therapy (hypotenstion or shock, ileus or bowel obstruction, megacolon).
  • Patients with an allergy to oral vancomycin or fidaxomicin.
  • Patients anticipated to receive metronidazole after enrollment.
  • Patients who already received oral vancomycin or metronidazole (either oral or intravenous) for > 24 hours within the preceding 72 hours at the time of enrollment.
  • Patients anticipated to receive adjunctive C. difficile therapy (rifaxamin, nitazoxanide, tigecycline) after enrollment.

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 identifier (NCT number): NCT02692651

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Contact: Jolene Daniel, CCRP 734-615-1901

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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Keith S Kaye, MD    734-615-1901   
Contact: Jolene Daniel, CCRP    734-615-1901   
St. Joseph Mercy Hospital Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Anurag Malani, MD    734-712-8600   
Contact: Kara Sawaya, RN, BSN    734-712-8087   
Sponsors and Collaborators
University of Michigan
Merck Sharp & Dohme Corp.
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Principal Investigator: Keith Kaye, MD, MPH University of Michigan
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Responsible Party: Keith Kaye, Professor, University of Michigan Identifier: NCT02692651    
Other Study ID Numbers: Merck Fidaxo
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Keith Kaye, University of Michigan:
Additional relevant MeSH terms:
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Communicable Diseases
Clostridium Infections
Enterocolitis, Pseudomembranous
Gram-Positive Bacterial Infections
Bacterial Infections
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Anti-Bacterial Agents
Anti-Infective Agents