Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Optimer Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01591863
First received: April 27, 2012
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).


Condition Intervention Phase
Clostridium Difficile-associated Diarrhea
Drug: fidaxomicin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2A, Multi-Center, Open-Label, Uncontrolled Study to Determine the Safety, Tolerability, and Pharmacokinetics of Fidaxomicin Oral Suspension or Tablets in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)

Resource links provided by NLM:


Further study details as provided by Optimer Pharmaceuticals:

Primary Outcome Measures:
  • Safety and tolerability of fidaxomicin using clinical laboratory tests (hematology, biochemistry, and urinalysis), vital signs, physical examination, electrocardiograms (ECGs), and incidence/severity of adverse events. [ Time Frame: Enrollment through end of study (Day 38-41) ] [ Designated as safety issue: Yes ]
  • Investigate concentrations of fidaxomicin and its main metabolite in plasma samples. [ Time Frame: Enrollment through end of therapy (Day 10) ] [ Designated as safety issue: No ]
  • Investigate concentrations of fidaxomicin and its main metabolite in fecal samples. [ Time Frame: Enrollment through end of therapy (Day 10) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the clinical outcome by assessment of clinical response. [ Time Frame: Day 10 ] [ Designated as safety issue: Yes ]
  • Evaluate the clinical outcome by assessment of sustained clinical response. [ Time Frame: 28 days post-treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: June 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fidaxomicin Drug: fidaxomicin

6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.

6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days.

Other Names:
  • Dificid, Dificlir, OPT-80
  • PAR-101

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female 6 months to 17 years 11 months of age, inclusive;
  • Female subjects of childbearing potential must use adequate contraception
  • Diagnosed with CDAD

Exclusion Criteria:

  • Concurrent use of oral vancomycin or metronidazole or any other effective treatments for CDAD
  • Fulminant colitis
  • History of inflammatory bowel disease
  • Pregnant or breast-feeding
  • Need for concurrent use of some P-glycoprotein inhibitors during therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591863

Locations
United States, California
Call For Information
Los Angeles, California, United States, 90095
United States, Colorado
Call For Information
Aurora, Colorado, United States, 80045
United States, District of Columbia
Call For Information
Washington, District of Columbia, United States, 20010
United States, Illinois
Call for information
Chicago, Illinois, United States, 60611
Call For Information
Chicago, Illinois, United States, 60637
United States, Indiana
Call For Information
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Call For Information
Louisville, Kentucky, United States, 40202
United States, Maryland
Call For Information
Baltimore, Maryland, United States, 21287
United States, New Jersey
Call For Information
Morristown, New Jersey, United States, 07960
United States, New York
Call For Information
Stony Brook, New York, United States, 11794
United States, Ohio
Call For Information
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Call For Information
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Call For Information
Houston, Texas, United States, 77030
United States, Utah
Call For Information
Salt Lake City, Utah, United States, 84113
Canada, Nova Scotia
Call For Information
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
Optimer Pharmaceuticals
Investigators
Study Director: Sherwood Gorbach, M.D. Optimer Pharmaceuticals
  More Information

No publications provided

Responsible Party: Optimer Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01591863     History of Changes
Other Study ID Numbers: OPT-80-206
Study First Received: April 27, 2012
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Optimer Pharmaceuticals:
Clostridium difficile-associated diarrhea
CDAD
Pediatric

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 30, 2014