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Clofazamine for the Treatment of Mycobacterium Avium Intracellulare(MAI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00652067
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : April 3, 2008
Information provided by:
Yale University

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.

Condition or disease
Infection, Mycobacterium Avium-Intracellulare

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Study Type : Observational
Actual Enrollment : 1 participants
Official Title: IND for One Patient to Receive Clofazamine for Treatment of MAI
Study Start Date : May 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Single patient

Inclusion Criteria:

  • Treatment of one patient with MAI

Exclusion Criteria:

  • No other patients will be treated

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00652067

Sponsors and Collaborators
Yale University
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Principal Investigator: Margaret Pisani, M.D. Yale University
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Responsible Party: Margaret Pisani, MD, Yale University School of Medicine Identifier: NCT00652067    
Other Study ID Numbers: 0604001371
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: April 3, 2008
Last Verified: March 2008
Keywords provided by Yale University:
Mycobacterium avium-intracellulare
Additional relevant MeSH terms:
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Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous