- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01591863
Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
August 16, 2018 updated by: Optimer Pharmaceuticals LLC
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)
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Enrollment through end of study (Day 38-41)
|
Investigate Concentrations of Fidaxomicin in Plasma Samples.
Time Frame: 3-5 hours after administration
|
3-5 hour plasma levels of fidaxomicin (mean)
|
3-5 hours after administration
|
Investigate Concentrations of Fidaxomicin in Fecal Samples.
Time Frame: End of Therapy; Day 10-11
|
End of therapy fecal levels of fidaxomicin (mean)
|
End of Therapy; Day 10-11
|
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)
|
3-5 hours after administration
|
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)
|
End of Therapy; Day 10-11
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the Clinical Outcome by Assessment of Clinical Response.
Time Frame: Day 10
|
Positive clinical response defined as resolution of diarrhea
|
Day 10
|
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
|
28 days post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2012
Primary Completion (Actual)
March 7, 2014
Study Completion (Actual)
March 7, 2014
Study Registration Dates
First Submitted
April 27, 2012
First Submitted That Met QC Criteria
May 2, 2012
First Posted (Estimate)
May 4, 2012
Study Record Updates
Last Update Posted (Actual)
September 18, 2018
Last Update Submitted That Met QC Criteria
August 16, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5119-010
- OPT-80-206 (Other Identifier: Optimerpharma Study Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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Optimer Pharmaceuticals LLCCompleted
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Astellas Pharma Europe B.V.Merck Sharp & Dohme LLCCompletedClostridium Difficile-associated Diarrhea (CDAD)United States, Belgium, Italy, Canada, France, Germany, Hungary, Poland, Romania, Spain
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Bio-K Plus International Inc.Sprim Advanced Life SciencesCompletedClostridium Difficile-Associated Diarrhea | Antibiotic-Associated Diarrhea
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Bernhard Nocht Institute for Tropical MedicineGerman Federal Ministry of Education and ResearchTerminatedDiarrhea | Antibiotic-associated Diarrhea | Clostridium DifficileGermany
Clinical Trials on fidaxomicin
-
Astellas Pharma Europe B.V.Merck Sharp & Dohme LLCCompletedClostridium Difficile-associated Diarrhea (CDAD)United States, Belgium, Italy, Canada, France, Germany, Hungary, Poland, Romania, Spain
-
Astellas Pharma Europe Ltd.CompletedInflammatory Bowel Disease (IBD) | Clostridium Difficile Infection (CDI)Austria, France, Greece, Italy, Poland, Russian Federation, United Kingdom
-
Baylor College of MedicineCubist Pharmaceuticals LLCTerminatedSpinal Cord Injury | Clostridium DifficileUnited States
-
University of Colorado, DenverWithdrawnClostridium Difficile Infection | Solid Organ Transplant
-
Astellas Pharma IncCompleted
-
Astellas Pharma S.A.S.Completed
-
Optimer Pharmaceuticals LLCCompletedDiarrhea | Clostridium Infections
-
Optimer Pharmaceuticals LLCCompleted
-
University of AlbertaTerminatedClostridium DifficileCanada
-
Benoit GueryRecruitingClostridioides Difficile InfectionSwitzerland