Feasibility and Accuracy of a Novel Xpert Cartridge

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02251327
• Other study ID #: NA_0008420
• Secondary ID: NA_0008420
• Status: Completed
• Start date: June 4, 2014
• Est. completion date: December 2015

Study information

• Verified date: August 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

• 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)

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Device:
• Investigational Xpert DST test
One investigational test performed directly on the same sputum specimen.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Boston Medical Center

Outcome

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