Evaluation of Non-Inferiority of Two Fast Follower Nucleic Acid Amplification Tests

Tuberculosis Clinical Trial

— FIND  

Official title:

Evaluation of Non-Inferiority of Two Fast Follower Nucleic Acid Amplification Tests for the Diagnosis of Pulmonary Tuberculosis in Comparison to Geneexpert MTB/RIF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252198
• Other study ID #: NA_00085221
• Secondary ID: NA_00085221
• Status: Completed
• Phase: N/A
• First received: September 23, 2014
• Last updated: December 8, 2017
• Start date: February 2014
• Est. completion date: January 2015

Study information

• Verified date: December 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Assess sensitivity and specificity of two nucleic acid amplification tests, namely Epistem Genedrive® and MolbioTruenat™ in raw sputum compared to the WHO-endorsed GeneXpert® MTB/RIF assay using a gold standard of four cultures

Description:

• Estimate the accuracy of the Epistem Genedrive® and MolbioTruenat™ in raw sputum and in sputum pellets.

• Assess the operational feasibility of Epistem Genedrive® and MolbioTruenat™

• Determine and compare costs between the Epistem Genedrive®, MolbioTruenat™, and Xpert MTB/RIF tests

Recruitment information / eligibility

• Status: Completed
• Enrollment: 504
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • Clinical suspicion of pulmonary TB (including cough =2 weeks and at least 1 other symptom typical of TB);

• Age 18 years or above;

• Willingness to have a study follow-up visit, if necessary, approximately two months after enrollment

• Willingness to provide 3 sputum specimens at enrollment

• Provision of informed consent.

Exclusion Criteria:

• • Receipt of =48 cumulative hours OR three or more doses of anti-TB treatment (defined as combination anti-TB therapy intended to treat active TB) within 60 days prior to completion of sputum collection;

• Inability to provide informed consent (e.g. mentally impaired)

• Enrolled individuals who do not provide a first sputum sample of = 2ml and a second and third sputum sample of = 1ml each will be classified as early exclusions.

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Other:
• Epistem Genedrive® and MolBio Truenat™
S1 will undergo direct smear and Epistem Genedrive® (optional for phase 2*) testing, before being homogenized with glass beads and split into three portions for testing with Epistem Genedrive®, MolBio Truenat™ and GeneXpert MTB/Rif® respectively. S2 and S3 will be randomized as to the order of testing using Epistem Genedrive® and MolBio Truenat™.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-inferiority of tests	Non-inferiority of Epistem Genedrive® MTB iD Test and MolBio Truenat™ TB Assay to GeneXpert MTB/RIF using a non-inferiority margin of 5% for sensitivity in smear-positive, culture-positive; 7% for overall C+ sensitivity; and 3% for specificity in smear-negative, culture-negatives	4 months
Primary	Sensitivity and specificity of Epistem Genedrive® MTB iD	Sensitivity and specificity of Epistem Genedrive® MTB iD Test on raw sputum before homogenization, homogenized raw sputum and sputum pellet against a gold standard of concentrated smear and four cultures.	4 months
Primary	Sensitivity and specificity of MolBio Truenat™ TB Assay	Sensitivity and specificity of MolBio Truenat™ TB Assay on homogenized raw sputum and sputum pellet against a gold standard of concentrated smear and four cultures.	4 months
Secondary	Failure rate for the Epistem Genedrive® system assay and for the MolBio Truenat™ assay	Failure rate for the Epistem Genedrive® system assay and for the MolBio Truenat™ assay, expressed as the proportion of tests that require repeating due to an indeterminate or uninterpretable initial result (separately and together for tests performed on raw sputum and sputum pellet	10 months
Secondary	Training needs for each assay	Training needs for each assay assessed objectively by number of hours of training, number of runs required, and successful completion of a proficiency assessment by trainees; training needs also will be assessed subjectively by the trainers and by user questionnaires	10 months
Secondary	Operational feasibility	Operational feasibility will be assessed according to the infrastructure required to support each test, the robustness of the reagents and equipment (any breakdowns, storage requirements or contamination events), and the time it takes to run each test;	10 months
Secondary	Cost-comparison between assays	A cost-comparison between assays assessing the cost per sample run incorporating all costs involved in transport, equipment, reagents, personnel, etc. will be performed.	10 months