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

Completed

Conditions studied: Tuberculosis

In brief

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

Key facts

Study ID

NCT02252198

Run by

Johns Hopkins University

People needed

504

Starts

2014-02-01

Expected to finish

2015-01-01

Last updated by the study team

2017-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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.

You may not qualify if…

• • 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.

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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