Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT00023335
Status:
COMPLETED
Last Update Posted:
2005-09-05
First Post:
2001-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TBTC Study 22: Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis
Sponsor:
Centers for Disease Control and Prevention
Organization:
Study Overview
Official Title:
TBTC Study 22: Efficacy and Safety of Once-Weekly Rifapentine and Isoniazid Compared to Efficacy and Safety of Once-Weekly Rifapentine and Isoniazid Compared to Twice-Weekly Rifampin and Isoniazid in the Continuation Phase of Therapy for Pulmonary Tuberculosis
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective: To compare, at the completion of the follow-up phase, the clinical and bacteriologic relapse rates associated with the two study regimens.
Secondary Objectives:
To compare the clinical and bacteriologic failure rates of the two study regimens at the completion of the study phase therapy.
To compare the clinical and bacteriologic response rates for the two study regimens among patients who began study phase therapy with signs and symptoms of tuberculosis or cultures positive for M. tuberculosis.
To compare the toxicity associated with the two study regimens by comparing discontinuation rates due to adverse events and occurrence rates of signs and symptoms associated with adverse events during study phase therapy.
To compare mortality rates of the two study regimens. To compare the rates of completion of therapy within 22 weeks for the two study regimens.
To compare the rate of development of drug-resistant tuberculosis in the two study regimens among study patients classified as treatment failures or relapses.
To compare all of the above performance characteristics for the two study regimens in a small subset of HIV seropositive patients.
To compare attitudes and beliefs about participation in this study between patients who complete study therapy and those who fail to complete study therapy.
Secondary Objectives:
To compare the clinical and bacteriologic failure rates of the two study regimens at the completion of the study phase therapy.
To compare the clinical and bacteriologic response rates for the two study regimens among patients who began study phase therapy with signs and symptoms of tuberculosis or cultures positive for M. tuberculosis.
To compare the toxicity associated with the two study regimens by comparing discontinuation rates due to adverse events and occurrence rates of signs and symptoms associated with adverse events during study phase therapy.
To compare mortality rates of the two study regimens. To compare the rates of completion of therapy within 22 weeks for the two study regimens.
To compare the rate of development of drug-resistant tuberculosis in the two study regimens among study patients classified as treatment failures or relapses.
To compare all of the above performance characteristics for the two study regimens in a small subset of HIV seropositive patients.
To compare attitudes and beliefs about participation in this study between patients who complete study therapy and those who fail to complete study therapy.
Detailed Description:
None
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| TBTC Study 22 | None | None | View |