Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection

NCT02395848 | Terminated Phase 3 Results DMC

• 1 other identifier: CDI.FIDAXOMICIN.1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This is a medical research study designed to look at the safety and efficacy of 30-day course of fidaxomicin for treatment of recurrent CDI (Clostridium difficile Infection). CDI is an infection that results when the normal flora (resident bacteria) of the colon is substantially altered by antibiotic treatment. The decrease in this normal flora allows for the growth of the C. difficile bacteria. Fidaxomicin is an antibiotic which is approved by Health Canada for treatment of CDI. Only patients with a primary case of CDI or 1st episode of recurrent CDI have been studied using a 10-day course of fidaxomicin.

Conditions

Clostridium Difficile Infection

Keywords

recurrent; infection

Outcome Measures

Primary Outcomes (3)

• Clinical Response at 30-day Completion of Fidaxomicin

  clinical response will be defined as those participants who have improvement in the number of bowel movements as determined by ≤ 3 unformed stools in a 24-hour period for 2 consecutive days during treatment and remaining well through study day 30.

  30 days

• Sustained Clinical Response 8 Weeks Following Completion of 30-day Course of Fidaxomicin

  sustained clinical response will be defined as those participants who have improvement in the number of bowel movements as determined by ≤ 3 unformed stools in a 24-hour period for 2 consecutive days during treatment and remaining well 8 weeks following completion of fidaxomicin

  8 week following completion of fidaxomicin

• Treatment Failure

  patients not meeting the definition of cure and requiring additional antibiotics for current CDI episode

  Up to 8 weeks following completion of fidaxomicin

Study Arms (1)

Fidaxomicin

EXPERIMENTAL

30-day Fidaxomicin ( 200mg twice daily x 10 days and 200mg once daily x 20 days.

Drug: Fidaxomicin

Interventions

Fidaxomicin DRUG

200mg twice daily for 10 days followed by 200mg once daily for 20 days to prevent future recurrence of CDI

Also known as: Dificid

Fidaxomicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Able to provide informed consent.
• Willing and able to comply with all the required study procedures.
• A positive stool test for C. difficile toxin/gene using either PCR or enzyme immunoassay within 3 months of recruitment.
• History of at least ≥ 2 recurrent CDI within 6 months where recurrence is defined as return of diarrhea consistent with CDI within 8 weeks following CDI symptom resolution for at least 24 hours after a minimum of 10-day course of standard antibiotic therapy and positive stool test for C. difficile toxin or toxin gene and/or ongoing symptoms consistent with CDI despite at least 5 days of treatment using oral vancomycin.

You may not qualify if:

• Planned or actively taking an investigational product for another study.
• Prior fidaxomicin use.
• Hypersensitivity to fidaxomicin or to any ingredient in the formulation or component of the container.
• Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray or life expectancy of less than 72 hours.
• Active gastroenteritis due to Salmonella, Shigella, shiga toxin-producing E. coli, Yersinia or Campylobacter.
• Anticipated requirement for systemic antibiotic therapy for more than 7 days during the study period.
• Actively taking Saccharomyces boulardii or other probiotics other than yogurt.
• Any condition that, in the opinion of the investigator, that the treatment may pose a health risk to the subject.
• Pregnant or lactating.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

Christine Lee

Victoria, BC - British Columbia, V8R 6CT, Canada

Location

MeSH Terms

Conditions

Clostridium Infections; Recurrence; Infections

Interventions

Fidaxomicin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Polyketides; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Christine Lee
• Organization: McMaster University

clee@mcmaster.ca

2505191898

Study Officials

• Christine H Lee, MD

  Vancouver Island Health Authority

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 24, 2015
• Study Start: July 1, 2015
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: March 24, 2023
• Results First Posted: March 24, 2023

Record last verified: 2022-06

Locations

CA (1)