Feasibility and Accuracy of a Novel Xpert Cartridge

Johns Hopkins University401 enrolled

Overview

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.

* For each of isoniazid, ofloxacin, moxifloxacin, amikacin, and kanamycin: sensitivity and specificity of the investigational Xpert test for detection of drug resistance, using phenotypic drug susceptibility testing as the reference comparator * For each of isoniazid, ofloxacin, moxifloxacin, amikacin, and kanamycin: sensitivity and specificity of the investigational Xpert test for detection of drug resistance, using mycobacterial DNA sequencing as the reference comparator * Sensitivity and specificity, for detection of M. tuberculosis in sputum, of the investigational Xpert test and of the conventional Xpert MTB/RIF test, using culture as the reference comparator * Diagnostic yield (for tuberculosis) of the investigational Xpert test and of the conventional Xpert MTB/RIF test * For the investigational Xpert test, the proportion of specimens with a result of 'invalid' and the proportion of specimens with a result of 'error' * Proportion of study participants with M. tuberculosis detected in sputum * Proportion of participants with drug resistant tuberculosis, by drug resistance pattern and by tuberculosis categorization (new case or not new case)

Study Type

OBSERVATIONAL

Enrollment

401

Conditions

Tuberculosis

Interventions

Investigational Xpert DST testDEVICE

One investigational test performed directly on the same sputum specimen.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 10 months

Secondary Outcomes

Diagnostic yield (for tuberculosis) of the investigational Xpert test and of the conventional Xpert MTB/RIF test

Time frame: 10 months

the proportion of specimens with a result of 'invalid' and the proportion of specimens with a result of 'error'

Time frame: 10 months

Proportion of study participants with TB and DRTB

Time frame: 10 months

Data from ClinicalTrials.gov

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