Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023439
Status:
COMPLETED
Last Update Posted:
2011-08-03
First Post:
2001-09-06
Brief Title:
TBTC NAA Study Pilot Study of Surrogate Markers for Outcome of TB Treatment
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Study of the Performance of Several Nucleic Acid Amplification Methodologies in the Diagnosis and Management of Active TB
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 is a pilot study to evaluate the performance of several nucleic acid amplification methodologies in the diagnosis and management of active tuberculosis
Detailed Description:
This study evaluates potential surrogate markers of treatment failure and relapse as a substudy of ongoing Tuberculosis Trials Consortium TBTC disease treatment studies After enrollment is complete specimens from cases of treatment failure and relapse will be evaluated in comparison to control samples to measure the prognostic value of the following tests 1 quantitative rRNA in 2-month sputum to predict relapse 2 MTB 85B mRNA to detect reactivation 3 1- to 4-month NAA and broth culture tests to predict relapse 4 mRNA rRNA and DNA at and after end of therapy to predict relapse 5sputum rRNA and blood DNA to detect recurrence during prodrome 6 sputum rRNA compared to cultures to diagnose paradoxical reactions 7 compare blood DNA to cultures at end of induction and end of treatment 8 compare accuracies of different NAA assays and standard cultures 9 determine MTD rRNA assay positive to negative conversion time 10 characterize quality and quantity of sputum over time in relation to culture and clinical outcome 11 assess ability of clinical radiographic and microbiologic risk factors to predict treatment failure and relapse
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 |
|---|---|---|---|
| NAA TBTC | None | None | None |