Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023374
Status:
COMPLETED
Last Update Posted:
2011-08-03
First Post:
2001-09-06
Brief Title:
TBTC Study 24 Intermittent Treatment of TB With Isoniazid Resistance or Intolerance
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
TBTC Study 24 A Non-Comparative Study of the Efficacy of a Largely-Intermittent Six-Month Tuberculosis Treatment Regimen Among Patients Who Will Not Receive Isoniazid Due to Initial Isoniazid Resistance or Intolerance
Status:
COMPLETED
Status Verified Date:
2011-06
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:
This study is a prospective open-label nonrandomized trial using a largely-intermittent six-month tuberculosis treatment regimen among patients who will not receive isoniazid due to the presence of initial isoniazid resistance or intolerance Subjects are enrolled after resistance or intolerance to isoniazid has been documented and are treated for a total of six months nine months if baseline chest x-ray shows cavitation and 2-month sputum culture is positive with twice weekly or thrice weekly rifampin ethambutol and pyrazinamide
Detailed Description:
Primary Objective
To evaluate the efficacy of a directly-observed largely-intermittent six-month regimen of rifampin pyrazinamide ethambutol among patients with culture confirmed isoniazid-resistant M tuberculosis
Secondary Objectives
To describe the rate severity and timing of toxicities and drug intolerances associated with this treatment regimen
To describe the utility of this regimen among patients who are unable to continue the standard 4-drug regimen due to the development of intolerance to isoniazid
To evaluate the efficacy of a directly-observed largely-intermittent six-month regimen of rifampin pyrazinamide ethambutol among patients with culture confirmed isoniazid-resistant M tuberculosis
Secondary Objectives
To describe the rate severity and timing of toxicities and drug intolerances associated with this treatment regimen
To describe the utility of this regimen among patients who are unable to continue the standard 4-drug regimen due to the development of intolerance to isoniazid
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 24 | None | None | None |