Clofazamine for the Treatment of Mycobacterium Avium Intracellulare(MAI)

This study has been completed.

Sponsored by:	Yale University
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00652067

Purpose

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
Infection, Mycobacterium Avium-Intracellulare

Drug Information available for: Clofazimine

U.S. FDA Resources

Study Type:	Observational
Official Title:	IND for One Patient to Receive Clofazamine for Treatment of MAI

Further study details as provided by Yale University:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	1
Study Start Date:	May 2006
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Only one patient is being treated under a single patient IND.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Single patient

Criteria

Inclusion Criteria:

Treatment of one patient with MAI

Exclusion Criteria:

No other patients will be treated

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652067

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator:

Margaret Pisani, M.D.

Yale University

More Information

Responsible Party:	Yale University School of Medicine ( Margaret Pisani, MD )
Study ID Numbers:	0604001371
Study First Received:	March 31, 2008
Last Updated:	April 2, 2008
ClinicalTrials.gov Identifier:	NCT00652067
Health Authority:	United States: Food and Drug Administration

Keywords provided by Yale University:

Mycobacterium avium-intracellulare

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Clofazimine

Mycobacterium avium complex infection
Mycobacterium Infections, Atypical
Mycobacterium avium-intracellulare Infection

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Physiological Effects of Drugs
Infection
Actinomycetales Infections
Pharmacologic Actions
Anti-Bacterial Agents
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on January 16, 2009