Tuberculosis Clinical Trial
— (XpertDST)Official title:
Feasibility and Accuracy of a Novel Xpert Cartridge for Rapid Molecular Detection of Drug Resistant Mycobacterium Tuberculosis in Sputum
Verified date | August 2018 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Consenting adults will be interviewed for demographic and medical information, and then will be asked to provide two expectorated sputum specimens. In the study laboratory, sputa will be tested using conventional and investigational diagnostic tests for tuberculosis.
Status | Completed |
Enrollment | 401 |
Est. completion date | December 2015 |
Est. primary completion date | June 15, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Individuals must meet all of the following inclusion criteria in order to be eligible to participate: - Age = 19 years (age of majority) if enrolled in South Korea; age = 18 years (age of majority) if enrolled in China - Provision of informed consent - Clinical signs and/or symptoms suggestive of pulmonary tuberculosis - Meets one of the following criteria: A. Suspected or confirmed new pulmonary tuberculosis case who has received anti-tuberculosis drugs for less than 3 (three) days (target enrollment for Group A is approximately 50 participants). B. Confirmed pulmonary tuberculosis with documented rifampin resistance, who has received anti-tuberculosis drugs for 31 days or less C. History of prior tuberculosis PLUS ongoing signs and/or symptoms of pulmonary tuberculosis PLUS suspected drug resistance Exclusion Criteria: - Inability to provide a sputum specimen |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Boston Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity and specificity | sensitivity and specificity of the investigational Xpert DST test for detection of drug resistance, using phenotypic drug susceptibility testing, mycobacterial DNA sequencing, and MTB/RIF test as the reference comparator | 10 months | |
Secondary | Diagnostic yield (for tuberculosis) of the investigational Xpert test and of the conventional Xpert MTB/RIF test | 10 months | ||
Secondary | the proportion of specimens with a result of 'invalid' and the proportion of specimens with a result of 'error' | 10 months | ||
Secondary | Proportion of study participants with TB and DRTB | 10 months |
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