Feasibility and Accuracy of a Novel Xpert Cartridge

NCT ID: NCT02251327

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 401 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-04
• Study Completion Date: 2015-12-31

Brief 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.

Detailed 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)

Conditions

Tuberculosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Case detection group

Suspected or confirmed new pulmonary tuberculosis cases who have received anti-tuberculosis drugs for less than 3 (three) days and provide up to two expectorated sputum specimens. One investigational Xpert DST test and one Xpert MTB/RIF test were performed directly on the same sputum specimen; in addition, one smear microscopy test, one mycobacterial liquid culture, and one solid culture were performed after digestion and decontamination of sputum.

Investigational Xpert DST test

Intervention Type: DEVICE

One investigational test performed directly on the same sputum specimen.

Drug resistance risk group

Confirmed pulmonary tuberculosis cases with documented rifampin resistance, who have received anti-tuberculosis drugs for 31 days or less and/or history of prior tuberculosis PLUS ongoing signs and/or cases with symptoms of pulmonary tuberculosis PLUS suspected drug resistance and provide up to two expectorated sputum specimens. One investigational Xpert DST test and one Xpert MTB/RIF test were performed directly on the same sputum specimen; in addition, one smear microscopy test, one mycobacterial liquid culture, and one solid culture were performed after digestion and decontamination of sputum.

Investigational Xpert DST test

Intervention Type: DEVICE

One investigational test performed directly on the same sputum specimen.

Interventions

Investigational Xpert DST test

One investigational test performed directly on the same sputum specimen.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Xie YL, Chakravorty S, Armstrong DT, Hall SL, Via LE, Song T, Yuan X, Mo X, Zhu H, Xu P, Gao Q, Lee M, Lee J, Smith LE, Chen RY, Joh JS, Cho Y, Liu X, Ruan X, Liang L, Dharan N, Cho SN, Barry CE 3rd, Ellner JJ, Dorman SE, Alland D. Evaluation of a Rapid Molecular Drug-Susceptibility Test for Tuberculosis. N Engl J Med. 2017 Sep 14;377(11):1043-1054. doi: 10.1056/NEJMoa1614915.

Reference Type: DERIVED

PMID: 28902596 (View on PubMed)

Other Identifiers

NA_0008420

Identifier Type: OTHER

Identifier Source: secondary_id

NA_0008420

Identifier Type: -

Identifier Source: org_study_id