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

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

Optimer Pharmaceuticals LLC

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.

General Publications

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

Keywords

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.

Clinical Trials on Clostridium Difficile-associated Diarrhea

Clinical Trials on fidaxomicin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe