Mycobacterium Avium-intracellulare InfectionPhase 2NCT00004689
Phase II Study of Amithiozone (Thiacetazone) for Patients With Mycobacterium Avium Complex Pulmonary Disease
A Phase 2 study testing amithiozone, clarithromycin and ethambutol in people with Mycobacterium Avium-intracellulare Infection, run by National Jewish Health.
Trial summary
OBJECTIVES: I. Determine the bacteriological activity of amithiozone against Mycobacterium avium complex (MAC) pulmonary disease. II. Define the ability of amithiozone to improve clinical outcomes in patients with MAC infection. III. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycobacterium Avium-intracellulare Infection
- What is being tested?
- amithiozone, clarithromycin and ethambutol
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 1991to Sep 1998
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Progressive pulmonary disease due to Mycobacterium avium complex (MAC) as defined by: Three of more sputum culture(s) positive for MAC Change in serial chest roentgenograms consistent with active mycobacterial disease over a 12 week period No other obvious cause of pulmonary disease
- Patients must have organisms that are: Susceptible to amithiozone AND Susceptible or moderately susceptible to the combination of rifampin and ethambutol, and to clarithromycin and streptomycin
--Prior/Concurrent Therapy--
- No likelihood of resectional thoracic surgery within 24 weeks of evaluation
--Patient Characteristics--
- Age: 18 and over
- Performance status: Not specified
- Hematopoietic: Not specified
- Hepatic: Bilirubin less than 3 times normal SGOT/SGPT less than 3 times normal Alkaline phosphatase less than 3 times normal
- Renal: Creatinine clearance at least 30 mL/min
- Cardiovascular: No New York Heart Association class III or IV heart failure
- Other: No optic disease that precludes the use of ethambutol No hypersensitivity to rifampin, ethambutol, clarithromycin, streptomycin, or amithiozone HIV negative Not pregnant or nursing
About this study
OBJECTIVES: I. Determine the bacteriological activity of amithiozone against Mycobacterium avium complex (MAC) pulmonary disease.
II. Define the ability of amithiozone to improve clinical outcomes in patients with MAC infection.
III. Determine the safety and tolerance of amithiozone with chronic dosing in these patients.
IV. Assess the contribution of clarithromycin, streptomycin, rifampin, ethambutol, kanamycin, and amithiozone in the treatment of pulmonary MAC infection.
Read the detailed description
PROTOCOL OUTLINE: The is a randomized, open label study. All patients receive a core regimen of clarithromycin and streptomycin. Patients are randomized into two treatment arms. Arm I patients receive rifampin and ethambutol. Arm II patients receive amithiozone.
Patients are followed for one year to detect any relapse or other complications.
Patients not eligible for this randomized study may be entered on a short open label study with amithiozone.
Completion date provided represents the completion date of the grant per OOPD records
- Being tested
- amithiozone, clarithromycin, ethambutol, rifampin, streptomycin
- Keywords
- bacterial infection, immunologic disorders and infectious disorders, mycobacterium avium infection, mycobacterium infection, rare disease
- Medical subject headings
- Mycobacterium avium-intracellulare Infection, Bacterial Infections, Immune System Diseases, Communicable Diseases, Mycobacterium Infections, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amithiozoneDrug
clarithromycinDrug
ethambutolDrug
rifampinDrug
streptomycinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startJan 1991
- Study completionSep 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium Avium-intracellulare InfectionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Investigators
- Charles Arthur Peloquin, Study chair, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004689
- Sponsor's protocol ID
- 199/13311
- Other IDs
- NJCIRM-HS-750, NJCIRM-FDR000812
- Status last verified
- Feb 1999
- First submitted
- 24 Feb 2000
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Amithiozone (Thiacetazone) for Patients With Mycobacterium Avium Complex Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00004689
- Acronym / sponsor ID
- 199/13311
- Keywords
- bacterial infection, immunologic disorders and infectious disorders, mycobacterium avium infection, mycobacterium infection, rare disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- Jan 1991
- Study completion
- Sep 1998
- First posted
- 25 Feb 2000 (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.
OBJECTIVES: I. Determine the bacteriological activity of amithiozone against Mycobacterium avium complex (MAC) pulmonary disease.
II. Define the ability of amithiozone to improve clinical outcomes in patients with MAC infection.
III. Determine the safety and tolerance of amithiozone with chronic dosing in these patients.
IV. Assess the contribution of clarithromycin, streptomycin, rifampin, ethambutol, kanamycin, and amithiozone in the treatment of pulmonary MAC infection.
Detailed description
PROTOCOL OUTLINE: The is a randomized, open label study. All patients receive a core regimen of clarithromycin and streptomycin. Patients are randomized into two treatment arms. Arm I patients receive rifampin and ethambutol. Arm II patients receive amithiozone.
Patients are followed for one year to detect any relapse or other complications.
Patients not eligible for this randomized study may be entered on a short open label study with amithiozone.
Completion date provided represents the completion date of the grant per OOPD records
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amithiozone | Drug | – |
| clarithromycin | Drug | – |
| ethambutol | Drug | – |
| rifampin | Drug | – |
| streptomycin | Drug | – |
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 25 Mar 2015.
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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.
Charles Arthur Peloquin study chair
National Jewish Health
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing amithiozone, clarithromycin and ethambutol in people with Mycobacterium Avium-intracellulare Infection, run by National Jewish Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Mar 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 25 Mar 2015.