Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004689
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Phase II Study of Amithiozone Thiacetazone for Patients With Mycobacterium Avium Complex Pulmonary Disease
Sponsor:
National Jewish Health
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Completion date provided represents the completion date of the grant per OOPD records
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
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NJCIRM-FDR000812 | None | None | None |
| NJCIRM-HS-750 | None | None | None |