Phase II Study of Amithiozone (Thiacetazone) for Patients With Mycobacterium Avium Complex Pulmonary Disease
Information source: FDA Office of Orphan Products Development
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycobacterium Avium-Intracellulare Infection
Intervention: amithiozone (Drug); clarithromycin (Drug); ethambutol (Drug); rifampin (Drug); streptomycin (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: FDA Office of Orphan Products Development Official(s) and/or principal investigator(s):
Charles Arthur Peloquin, Study Chair, Affiliation: National Jewish Medical and Research Center
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. 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.
Clinical Details
Study design: Treatment, Randomized, Open Label, Efficacy Study
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: January 1991
Last updated: June 23, 2005
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