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

NCT00004689 | Completed Phase 2

• 3 other identifiers: 199/13311NJCIRM-HS-750NJCIRM-FDR000812
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Mycobacterium Avium-intracellulare Infection

Keywords

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

Interventions

amithiozone DRUG

clarithromycin DRUG

ethambutol DRUG

rifampin DRUG

streptomycin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Jewish Health: lead

MeSH Terms

Conditions

Mycobacterium avium-intracellulare Infection; Bacterial Infections; Immune System Diseases; Communicable Diseases; Mycobacterium Infections; Rare Diseases

Interventions

Thioacetazone; Clarithromycin; Ethambutol; Rifampin; Streptomycin

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections and Mycoses; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiosemicarbazones; Semicarbazones; Semicarbazides; Organic Chemicals; Sulfur Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Ethylenediamines; Diamines; Polyamines; Amines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Charles Arthur Peloquin

  National Jewish Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: January 1, 1991
• Study Completion: September 1, 1998
• Last Updated: March 25, 2015

Record last verified: 1999-02