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Clofazamine for the Treatment of Mycobacterium Avium Intracellulare(MAI)

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ClinicalTrials.gov 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

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
Primary Completion Date : May 2007
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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 ClinicalTrials.gov identifier (NCT number): NCT00652067

Sponsors and Collaborators
Yale University
Principal Investigator: Margaret Pisani, M.D. Yale University

Responsible Party: Margaret Pisani, MD, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00652067     History of Changes
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:
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous
Anti-Inflammatory Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents