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

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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	FDA Office of Orphan Products Development National Jewish Medical and Research Center
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:

Ethambutol hydrochloride Ethambutol Clarithromycin Rifampin Streptomycin Streptomycin sulfate Thioacetazone

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 Medical and Research Center

Investigators


Study Chair:	Charles Arthur Peloquin	National Jewish Medical and Research Center

More Information

Study ID Numbers:	199/13311, NJCIRM-HS-750, NJCIRM-FDR000812
First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004689
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-intracellulare Infection

Clarithromycin

Rifampin

Gram-Positive Bacterial Infections

Lung Diseases

Mycobacterium Infections

Ethambutol

Mycobacterium avium complex infection

Additional relevant MeSH terms:

Protein Synthesis Inhibitors

Anti-Infective Agents

Anti-Bacterial Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Enzyme Inhibitors

Antitubercular Agents

Infection

Pharmacologic Actions

Actinomycetales Infections

ClinicalTrials.gov processed this record on December 03, 2008