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Sponsored by: |
Yale University |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00652067 |
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 |
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Infection, Mycobacterium Avium-Intracellulare |
Study Type: | Observational |
Official Title: | IND for One Patient to Receive Clofazamine for Treatment of MAI |
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 |
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1
Only one patient is being treated under a single patient IND.
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Single patient
Inclusion Criteria:
Exclusion Criteria:
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 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Mycobacterium avium-intracellulare |
Bacterial Infections Anti-Inflammatory Agents Anti-Infective Agents Clofazimine Mycobacterium Infections, Atypical Mycobacterium Avium Complex Infection Mycobacterium avium-intracellulare Infection Anti-Bacterial Agents |
Gram-Positive Bacterial Infections Analgesics, Non-Narcotic Mycobacterium Infections Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
Anti-Inflammatory Agents Bacterial Infections Anti-Infective Agents Physiological Effects of Drugs Clofazimine Infection Actinomycetales Infections Mycobacterium Infections, Atypical Pharmacologic Actions Mycobacterium avium-intracellulare Infection Anti-Bacterial Agents |
Gram-Positive Bacterial Infections Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Mycobacterium Infections Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Leprostatic Agents |