MedDataX Logo

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

NCT ID: NCT02252198

Last Updated: 2017-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

504 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tuberculosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Investigational

• Participants will be asked to provide a total of three sputum samples over Days 1 and 2. The intent is for all samples to be collected before the subject starts any form of TB treatment. The first specimen (S1) should be 2 ml or greater in volume, and the second and third specimens (S2 and S3) should each be 1 ml or greater in volume. On Day 1, each participant will be asked to submit one spot sputum (S1) after enrollment and a second spot sputum after at least 2 hours (S2). Participants will be instructed to come back the following day (Day 2) and provide a third spot sputum (S3). In the event that a participant fails to return on Day 2, S3 may be collected a maximum of 7 days after enrollment, provided that no TB treatment has been initiated.

Epistem Genedrive® and MolBio Truenat™

Intervention Type 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™.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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™.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boston Medical Center

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Inbaraj LR, Daniel J, Sathya Narayanan MK, Srinivasalu VA, Bhaskar A, Scandrett K, Rajendran P, Kirubakaran R, Shewade HD, Malaisamy M, Padmapriyadarsini C, Takwoingi Y. Truenat MTB assays for pulmonary tuberculosis and rifampicin resistance in adults and adolescents. Cochrane Database Syst Rev. 2025 Mar 24;3(3):CD015543. doi: 10.1002/14651858.CD015543.pub2.

Reference Type DERIVED
PMID: 40122135 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NA_00085221

Identifier Type: OTHER

Identifier Source: secondary_id

NA_00085221

Identifier Type: -

Identifier Source: org_study_id