Infection, Mycobacterium Avium-IntracellulareNCT00652067
Clofazamine for the Treatment of Mycobacterium Avium Intracellulare(MAI)
An observational study of Infection, Mycobacterium Avium-Intracellulare, run by Yale University.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infection, Mycobacterium Avium-Intracellulare
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- May 2006to May 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Single patient
Who may be able to join
- Treatment of one patient with MAI
Who cannot join
- No other patients will be treated
About this study
Official title: 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.
- Keywords
- Mycobacterium avium-intracellulare
- Medical subject headings
- Mycobacterium avium-intracellulare Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Only one patient is being treated under a single patient IND. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startMay 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Mycobacterium Avium-IntracellulareStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Investigators
- Margaret Pisani, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652067
- Sponsor's protocol ID
- 0604001371
- Status last verified
- Mar 2008
- First submitted
- 31 Mar 2008
- Last updated
- 3 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IND for One Patient to Receive Clofazamine for Treatment of MAI
- ClinicalTrials.gov ID
- NCT00652067
- Acronym / sponsor ID
- 0604001371
- Keywords
- Mycobacterium avium-intracellulare
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 3 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Only one patient is being treated under a single patient IND. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Single patient
Key inclusion criteria (1 listed)
- Treatment of one patient with MAI
Key exclusion criteria (1 listed)
- No other patients will be treated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2008.
Related trials for Infection, Mycobacterium Avium-Intracellulare
RecruitingObservational study
Study of Mycobacterial Infections
Mycobacterium Infections
RecruitingPhase 4
Hypertonic Saline for MAC
Nontuberculous Mycobacterial Lung Disease, Nontuberculous Mycobacterium Infection
Recruiting
Treating Severe Mitral Valve Annular or Valvular Calcification Using Shockwave Balloon SMARTWAVE
Mitral Annulus Calcification, Rheumatic Heart Disease
RecruitingPhase 4
Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease
Nontuberculous Mycobacterial Lung Disease, Mycobacterium Avium Complex
Recruiting
Hypertonic Saline Inhalation for Nontuberculous Mycobacterial Lung Disease
Nontuberculous Mycobacterial Lung Disease, Bronchiectasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Pisani, M.D. principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, Mycobacterium Avium-Intracellulare, run by Yale University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2008.