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Phase II Study of Amithiozone (Thiacetazone) for Patients With Mycobacterium Avium Complex Pulmonary Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004689
First Posted: February 25, 2000
Last Update Posted: March 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
FDA Office of Orphan Products Development
  Purpose

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.


Condition Intervention Phase
Mycobacterium Avium-intracellulare Infection Drug: amithiozone Drug: clarithromycin Drug: ethambutol Drug: rifampin Drug: streptomycin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 50
Study Start Date: January 1991
Estimated Study Completion Date: September 1998
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004689


Sponsors and Collaborators
National Jewish Health
Investigators
Study Chair: Charles Arthur Peloquin National Jewish Health
  More Information

ClinicalTrials.gov Identifier: NCT00004689     History of Changes
Other Study ID Numbers: 199/13311
NJCIRM-HS-750
NJCIRM-FDR000812
First Submitted: February 24, 2000
First Posted: February 25, 2000
Last Update Posted: March 25, 2015
Last Verified: February 1999

Keywords provided by FDA Office of Orphan Products Development:
bacterial infection
immunologic disorders and infectious disorders
mycobacterium avium infection
mycobacterium infection
rare disease

Additional relevant MeSH terms:
Infection
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Mycobacterium Infections, Nontuberculous
Clarithromycin
Rifampin
Ethambutol
Streptomycin
Thioacetazone
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers