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Completed

NCT Number: NCT02252198

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

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

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Epistem Genedrive® and MolBio Truenat™

Other

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™.

Primary outcomes

  1. Non-inferiority of tests

    Time frame: 4 months

    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

  2. Sensitivity and specificity of Epistem Genedrive® MTB iD

    Time frame: 4 months

    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.

  3. Sensitivity and specificity of MolBio Truenat™ TB Assay

    Time frame: 4 months

    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.

Secondary outcomes

  1. Failure rate for the Epistem Genedrive® system assay and for the MolBio Truenat™ assay

    Time frame: 10 months

    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

  2. Training needs for each assay

    Time frame: 10 months

    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

  3. Operational feasibility

    Time frame: 10 months

    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;

  4. Cost-comparison between assays

    Time frame: 10 months

    A cost-comparison between assays assessing the cost per sample run incorporating all costs involved in transport, equipment, reagents, personnel, etc. will be performed.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Boston Medical Center

Registry information

Official study 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

Acronym: FIND

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 30, 2014
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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