Clofazamine for the Treatment of Mycobacterium Avium Intracellulare(MAI)

Infection, Mycobacterium Avium-Intracellulare Clinical Trial

Official title:

IND for One Patient to Receive Clofazamine for Treatment of MAI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00652067
• Other study ID #: 0604001371
• Status: Completed
• Phase: N/A
• First received: March 31, 2008
• Last updated: April 2, 2008
• Start date: May 2006
• Est. completion date: May 2007

Study information

• Verified date: March 2008
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Treatment of one patient with MAI

Exclusion Criteria:

• No other patients will be treated

Study Design

N/A

Related Conditions & MeSH terms

• Infection, Mycobacterium Avium-Intracellulare
• Mycobacterium avium-intracellulare Infection
• Mycobacterium Infections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yale University