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

Primary Purpose

Clostridium Difficile-associated Diarrhea

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
fidaxomicin
Sponsored by
Optimer Pharmaceuticals LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile-associated Diarrhea focused on measuring Clostridium difficile-associated diarrhea, CDAD, Pediatric

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    fidaxomicin

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of Participants With Adverse Events.
    Number of participants with adverse events, as categorized by MedDRA.
    Investigate Concentrations of Fidaxomicin in Plasma Samples.
    3-5 hour plasma levels of fidaxomicin (mean)
    Investigate Concentrations of Fidaxomicin in Fecal Samples.
    End of therapy fecal levels of fidaxomicin (mean)
    Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.
    3-5 hour plasma levels of OP-1118 (mean)
    Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.
    End of therapy fecal levels of OP-1118 (mean)

    Secondary Outcome Measures

    Evaluate the Clinical Outcome by Assessment of Clinical Response.
    Positive clinical response defined as resolution of diarrhea
    Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response.
    Positive clinical response without recurrence through the follow-up period

    Full Information

    First Posted
    April 27, 2012
    Last Updated
    August 16, 2018
    Sponsor
    Optimer Pharmaceuticals LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01591863
    Brief Title
    Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 15, 2012 (Actual)
    Primary Completion Date
    March 7, 2014 (Actual)
    Study Completion Date
    March 7, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Optimer Pharmaceuticals LLC

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Clostridium Difficile-associated Diarrhea
    Keywords
    Clostridium difficile-associated diarrhea, CDAD, Pediatric

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    fidaxomicin
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    fidaxomicin
    Other Intervention Name(s)
    Dificid, Dificlir, OPT-80, PAR-101
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Number of Participants With Adverse Events.
    Description
    Number of participants with adverse events, as categorized by MedDRA.
    Time Frame
    Enrollment through end of study (Day 38-41)
    Title
    Investigate Concentrations of Fidaxomicin in Plasma Samples.
    Description
    3-5 hour plasma levels of fidaxomicin (mean)
    Time Frame
    3-5 hours after administration
    Title
    Investigate Concentrations of Fidaxomicin in Fecal Samples.
    Description
    End of therapy fecal levels of fidaxomicin (mean)
    Time Frame
    End of Therapy; Day 10-11
    Title
    Investigate Concentrations of the Main Metabolite OP-1118 in Plasma Samples.
    Description
    3-5 hour plasma levels of OP-1118 (mean)
    Time Frame
    3-5 hours after administration
    Title
    Investigate Concentrations of the Main Metabolite OP-1118 in Fecal Samples.
    Description
    End of therapy fecal levels of OP-1118 (mean)
    Time Frame
    End of Therapy; Day 10-11
    Secondary Outcome Measure Information:
    Title
    Evaluate the Clinical Outcome by Assessment of Clinical Response.
    Description
    Positive clinical response defined as resolution of diarrhea
    Time Frame
    Day 10
    Title
    Evaluate the Clinical Outcome by Assessment of Sustained Clinical Response.
    Description
    Positive clinical response without recurrence through the follow-up period
    Time Frame
    28 days post-treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    28575523
    Citation
    O'Gorman MA, Michaels MG, Kaplan SL, Otley A, Kociolek LK, Hoffenberg EJ, Kim KS, Nachman S, Pfefferkorn MD, Sentongo T, Sullivan JE, Sears P. Safety and Pharmacokinetic Study of Fidaxomicin in Children With Clostridium difficile-Associated Diarrhea: A Phase 2a Multicenter Clinical Trial. J Pediatric Infect Dis Soc. 2018 Aug 17;7(3):210-218. doi: 10.1093/jpids/pix037.
    Results Reference
    result

    Learn more about this trial

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

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