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Clofazamine for the Treatment of Mycobacterium Avium Intracellulare(MAI)

Primary Purpose

Infection, Mycobacterium Avium-Intracellulare

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Infection, Mycobacterium Avium-Intracellulare focused on measuring Mycobacterium avium-intracellulare

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Treatment of one patient with MAI

Exclusion Criteria:

  • No other patients will be treated

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Arm Label

    1

    Arm Description

    Only one patient is being treated under a single patient IND.

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 31, 2008
    Last Updated
    April 2, 2008
    Sponsor
    Yale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00652067
    Brief Title
    Clofazamine for the Treatment of Mycobacterium Avium Intracellulare(MAI)
    Official Title
    IND for One Patient to Receive Clofazamine for Treatment of MAI
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    March 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    May 2007 (Actual)
    Study Completion Date
    May 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Yale University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This protocol is an single patient IND to provide clofazamine to treat one patient who has MAI and is resistant to or can not tolerate standard of care. The drug is not otherwise available.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infection, Mycobacterium Avium-Intracellulare
    Keywords
    Mycobacterium avium-intracellulare

    7. Study Design

    Enrollment
    1 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Description
    Only one patient is being treated under a single patient IND.

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Treatment of one patient with MAI Exclusion Criteria: No other patients will be treated
    Study Population Description
    Single patient
    Sampling Method
    Non-Probability Sample
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Margaret Pisani, M.D.
    Organizational Affiliation
    Yale University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Clofazamine for the Treatment of Mycobacterium Avium Intracellulare(MAI)

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