|
Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease Clinical research trials and Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease. Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease clinical trial. Test subjects typically obtain the finest healthcare available for their Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease  Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease
Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease
For Condition: Mycobacterium avium-intracellulare Infection
Status: No longer recruiting
Sponsor(s): FDA Office of Orphan Products Development , National Jewish Center for Immunology and Respiratory Medicine
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Open Label, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 50
Location and Contact Information:
Overall Study Official:
CharlesPeloquin, Study Chair, National Jewish Center for Immunology and Respiratory Medicine
Additional Information:
Study ID Numbers: 199/13311; NJCIRM-HS-750,NJCIRM-FDR000812
Study Start Date: January 1991
Record last reviewed: February 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004689
Other Mycobacterium Avium-Intracellulare Infection Studies:
1. A Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination with Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs Patients
2. The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent Mycobacterium Avium Complex (MAC) or Disseminated MAC Disease in HIV-Infected Patients
3. Long-Term Assessment for Metabolic, Cardiovascular and Neurologic Problems in HIV-Infected Patients with Increased CD4 Cells Counts Following Anti-HIV Therapy
4. A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium avium Infection in HIV-Infected Individuals.
5. A Study to Examine the Effects of Stopping Preventive Therapy for Disseminated Mycobacterium Avium Complex (DMAC) in HIV-Positive Patients
Related Studies:
Other Mycobacterium avium-intracellulare Infection Clinical Trials
Other Clinical Trials
Other Clinical Trials
Phase II Study of Amithiozone (Thiacetazone) for Patients with Mycobacterium Avium Complex Pulmonary Disease
|
|
|
|
|
|
|
|
