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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 LLC
ClinicalTrials.gov Identifier:
NCT01591863
First received: April 27, 2012
Last updated: March 23, 2017
Last verified: March 2017
  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: Intervention Model: Single Group Assignment
Masking: No masking
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 LLC:

Primary Outcome Measures:
  • Number of Participants With Adverse Events. [ Time Frame: Enrollment through end of study (Day 38-41) ]
    Number of participants with adverse events, as categorized by MedDRA.

  • Investigate Concentrations of Fidaxomicin in Plasma Samples. [ Time Frame: 3-5 hours after administration ]
    3-5 hour plasma levels of fidaxomicin (mean)

  • Investigate Concentrations of Fidaxomicin in Fecal Samples. [ Time Frame: End of Therapy; Day 10-11 ]
    End of therapy fecal levels of fidaxomicin (mean)

  • Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples. [ Time Frame: 3-5 hours after administration ]
    3-5 hour plasma levels of OP-1118 (mean)

  • Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples. [ Time Frame: End of Therapy; Day 10-11 ]
    End of therapy fecal levels of OP-1118 (mean)


Secondary Outcome Measures:
  • Evaluate the Clinical Outcome by Assessment of Clinical Response. [ Time Frame: Day 10 ]
    Positive clinical response defined as resolution of diarrhea

  • Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response. [ Time Frame: 28 days post-treatment ]
    Positive clinical response without recurrence through the follow-up period


Enrollment: 38
Actual Study Start Date: June 15, 2012
Study Completion Date: March 7, 2014
Primary Completion Date: March 7, 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   (Child, Adult)
Sexes Eligible for Study:   All
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

Sponsors and Collaborators
Optimer Pharmaceuticals LLC
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Optimer Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01591863     History of Changes
Other Study ID Numbers: 5119-010
OPT-80-206 ( Other Identifier: Optimerpharma Study Number )
Study First Received: April 27, 2012
Results First Received: March 5, 2015
Last Updated: March 23, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


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

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

ClinicalTrials.gov processed this record on May 22, 2017