Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023335
Status:
COMPLETED
Last Update Posted:
2005-09-05
First Post:
2001-09-06
Brief Title:
TBTC Study 22 Efficacy of Once-Weekly Rifapentine and Isoniazid in Treatment of Tuberculosis
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
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:
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 |
|---|---|---|---|
| TBTC Study 22 | None | None | None |