Clofazamine for the Treatment of Mycobacterium Avium Intracellulare(MAI)

April 2, 2008 updated by: Yale University

IND for One Patient to Receive Clofazamine for Treatment of MAI

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Single patient

Description

Inclusion Criteria:

  • Treatment of one patient with MAI

Exclusion Criteria:

  • No other patients will be treated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
1
Only one patient is being treated under a single patient IND.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Margaret Pisani, M.D., Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria

April 2, 2008

First Posted (Estimate)

April 3, 2008

Study Record Updates

Last Update Posted (Estimate)

April 3, 2008

Last Update Submitted That Met QC Criteria

April 2, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0604001371

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infection, Mycobacterium Avium-Intracellulare

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