Line Probe Assay Evaluation Study

Pulmonary Tuberculoses Clinical Trial

— YD  

Official title:

Multi-center Study to Assess the Non-inferiority of YD REBA MTB-MDR® and Hain GenoType® MTBDRplus V2 Line Probe Assays Compared to Hain GenoType® MTBDRplus V1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02984579
• Other study ID #: YD7012-03
• Status: Completed
• Phase: N/A
• First received: November 30, 2016
• Last updated: February 13, 2017
• Start date: March 2015
• Est. completion date: January 2016

Study information

• Verified date: February 2017
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a multi-center, blinded study to determine the performance of the YD Diagnostic Corporation (YD) REBA MTB-MDR® and Hain Genotype MTBDRplus V2 kit in a total of 600 clinical isolates and 900 residual sputum samples from patients with symptoms of pulmonary TB (PTB) and at risk of drug resistance. All testing was done on stored, de-identified leftover samples.

The study involved three World Health Organization (WHO) Supranational Reference Laboratories with well-characterized strain collections and access to sputum samples with significant rates of drug resistance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 888
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age over 18 years

• Informed consent

• Patients evaluated for pulmonary TB

Exclusion Criteria:

Related Conditions & MeSH terms

• Isoniazid Resistant Pulmonary Tuberculosis
• Multidrug-Resistant Tuberculosis
• Pulmonary Tuberculoses
• Rifampicin Resistant Tuberculosis
• Tuberculosis
• Tuberculosis, Multidrug-Resistant
• Tuberculosis, Pulmonary

Intervention

Device:
• YD REBA MTB-MDR
Conducted on stored, de-identified leftover samples. A line probe assay designed for detection of Multidrug-resistant tuberculosis (MDR-TB). The REBA MTB-MDR® assay is a qualitative in vitro test for the identification of Mycobacterium tuberculosis (MTB) complex and its susceptibility to rifampin and isoniazid from cultured samples and smear positive specimens.
• Hain Genotype MTBDRplus V1
Conducted on stored, de-identified leftover samples. There is only one Line Probe Assay for molecular MTB drug resistance globally available, the GenoType® MTBDRplus V.1 from Hain Lifescience. This assay includes rpoB gene probes for Rifampin (RIF) resistance, katG gene probes for high level Isoniazid (INH) resistance, and inhA gene probes for determination of low level INH resistance
• Hain Genotype MTBDRplus V2
Conducted on stored, de-identified leftover samples. An updated version of the Hain Genotype MTBDRplus V1 assay, the Genotype MTBDRplus V.2 line probe assay, showed increased sensitivity for MTB detection in the 2 studies published so far

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland	Institute of Tropical Medicine, Belgium, National Institute for Communicable Diseases, South Africa, Research Center Borstel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	INH/RIF Resistance Detection		At the end of study 9-10 Months after the Study started
Secondary	Multi-Drug Resistant TB detection	Is the subject resistant to both INH and RIF	At the end of study 9-10 Months after the Study started