Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421798
Status:
COMPLETED
Last Update Posted:
2009-07-09
First Post:
2007-01-11
Brief Title:
Rapid Characterization of Paucibacillary TB Along TexMex Border
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Rapid Characterization of Mycobacteria and Drug Resistance In Paucibacillary TB
Status:
COMPLETED
Status Verified Date:
2009-07
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 will test a method of detecting tuberculosis-causing bacteria that are resistant to current medication treatments Blood samples will be collected from patients from 3 sites and 3 mainly Hispanic populations in Texas Mexico and Colombia Up to 780 males and females ages 18-85 years will participate The study population will consist of 390 people with any of 3 forms of tuberculosis TB and 390 people who are either healthy or with a disease initially thought to be one of these 3 forms of TB but then ruled out Volunteers will only be contacted invited to participate and interviewed at the beginning of their evaluation for possible TBThe study team will follow up with the health department to determine if the volunteer was indeed diagnosed with TB and with the laboratory to determine the results of TB tests at diagnosis and during the course of treatment
Detailed Description:
Global challenges to tuberculosis TB control are multidrug resistance TB MDR-TB and the increased susceptibility of populations such as elderly those with HIV infection type 2 diabetes and other immunosuppressive chronic diseases The first primary study objective is to examine the potential of the investigators new DNA extractionqPCR protocol as a non-invasive tool to study pathogenesis in a range of paucibacillary specimens The investigators will evaluate their DNA extractionqPCR assays prospectively in specimens from patients with paucibacillary TB including extra-pulmonary TB EPTB and smear-negative pulmonary TB Investigators will determine the number of mycobacterial genomes presence of intact mycobacteria and precise location within plasma PBMCs or PMNs in blood or other fluid or cells in a range of specimens The second primary study objective is to standardize and validate a qPCR assay for early detection of Mycobacterium tuberculosis MTB drug resistance directly from specimens The investigators will further establish the feasibility of using this highly sensitive assay to determine the ratio of Rifampin RIF-resistant to RIF-susceptible bacteria in a given specimen The investigators will adapt a simple and effective method similar to their qPCR technology for detection of mutations in the rpoB gene MTB-positive specimens identified by either qPCR or direct smear will be screened for RIF resistance using molecular beacons as probes in qPCR The concordance between the molecular beacon-qPCR assays and resistance phenotype from culture will be established The investigators will then utilize the capacity of qPCR to quantitate ratios of RIF-resistant to -sensitive mycobacteria in a clinical specimen The investigators hypothesize that current assays are limited to indicating presence of drug susceptibility but in the patient the situation is more complex with dynamic mixtures of resistant and sensitive bacteria depending on local exposure to drugs Developing a tool that detects minor populations of drug-resistance cells will open new avenues of investigation to help understand development of resistance and treatment failures Primary study outcomes include anticipation that the qPCR in blood WBCs will provide substantially improved sensitivity and precision mycobacterial species information in the diagnosis of paucibacillary TB specifically tuberculous lymphadenitis pleural TB and smear-negative early pulmonary TB when compared with standard microbiological and clinical diagnosis anticipation that molecular beacon-qPCR will predict RIF-resistance with 100 sensitivity and at least 86 sensitivity in their study site providing a new tool for early suspicion of MDR and hence prompt modification in the treatment schedule of the patient and investigators will learn about the biology of emergence of RIF resistance in a population of mycobacteria from serial patient specimens Specimens will be collected from patients from 3 sites all with predominantly Hispanic populations located in South Texas adjacent northeast Mexico and Colombia A maximum of 780 males and females ages 18-85 years will be recruited The study population will consist of 390 people with tuberculosis 62 with TB lymphadenitis and at most 164 with pleural TB and 164 with smear-negative pulmonary TB and 390 controls either healthy controls or with a disease initially thought to be one of the three forms of TB described for cases but then ruled out Subjects will have 1 study related visit Patients will only be contacted invited to participate and interviewed at the beginning of their evaluation for possible TB The study team will follow-up with the health department to determine if the patient was indeed diagnosed with TB and with the laboratory to determine the results of serial direct smear culture and sensitivity at diagnosis and during the course of treatment
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