Status:
COMPLETED
Evaluation of Non-Inferiority of Two Fast Follower Nucleic Acid Amplification Tests
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Boston Medical Center
Conditions:
Tuberculosis
Eligibility:
All Genders
18+ years
Brief 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 gol...
Detailed 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 ...
Eligibility Criteria
Inclusion
- • 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
- • 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.
Key Trial Info
Start Date :
February 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT02252198
Start Date
February 1 2014
End Date
January 1 2015
Last Update
December 12 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins University
Baltimore, Maryland, United States, 21287