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Clofazamine for the Treatment of Mycobacterium Avium Intracellulare(MAI)

This study has been completed.
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00652067
First received: March 31, 2008
Last updated: April 2, 2008
Last verified: March 2008
History of Changes
  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

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

Resource links provided by NLM:

Drug Information available for: Clofazimine
U.S. FDA Resources

Further study details as provided by Yale University:

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

No publications provided

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

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, Atypical
Clofazimine
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013