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

This study is ongoing, but not recruiting participants.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	FDA Office of Orphan Products Development National Jewish Health
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004689

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 II

Drug Information available for: Streptomycin Rifampin Clarithromycin Ethambutol Thioacetazone Ethambutol hydrochloride Streptomycin sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Efficacy Study

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

Estimated Enrollment:	50
Study Start Date:	January 1991

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004689

Sponsors and Collaborators

FDA Office of Orphan Products Development

National Jewish Health

Investigators

Study Chair:

Charles Arthur Peloquin

National Jewish Health

More Information

No publications provided

Study ID Numbers:	199/13311, NJCIRM-HS-750, NJCIRM-FDR000812
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004689 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

bacterial infection
immunologic disorders and infectious disorders
mycobacterium avium infection
mycobacterium infection
rare disease

Study placed in the following topic categories:

Bacterial Infections
Thioacetazone
Rare Diseases
Streptomycin
Mycobacterium Infections, Atypical
Mycobacterium Avium Complex Infection
Mycobacterium avium-intracellulare Infection
Anti-Bacterial Agents

Clarithromycin
Rifampin
Gram-Positive Bacterial Infections
Lung Diseases
Mycobacterium Infections
Ethambutol
Antitubercular Agents

Additional relevant MeSH terms:

Bacterial Infections
Thioacetazone
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Streptomycin
Infection
Pharmacologic Actions
Actinomycetales Infections
Mycobacterium Infections, Atypical

Mycobacterium avium-intracellulare Infection
Protein Synthesis Inhibitors
Clarithromycin
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Therapeutic Uses
Mycobacterium Infections
Ethambutol
Antitubercular Agents

ClinicalTrials.gov processed this record on May 07, 2009