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NCT02252198 · ClinicalTrials.gov registry record
Evaluation of Non-Inferiority of Two Fast Follower Nucleic Acid Amplification Tests
A clinical trial, sponsored by Johns Hopkins University.
- Completed
- Registry status
- 504
- Enrollment target
NCT02252198: Completed study, sponsored by Johns Hopkins University.
NCT02252198 is a clinical trial that has completed, run by Johns Hopkins University. The registered enrollment target is 504 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02252198 has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- 504 participants
- Enrollment target
Study 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
Primary Outcome
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
Interventions
- OTHER Epistem Genedrive® and MolBio Truenat™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 504 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-01 |
What the finished NCT02252198 record still lists
NCT02252198 is an observational study that tracks outcomes without assigning an intervention. The registered 504 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Epistem Genedrive® and MolBio Truenat™ is the first listed.
NCT02252198 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02252198 about?
NCT02252198 is a clinical study titled "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
What is the current status of trial NCT02252198?
This trial is currently completed. The enrollment target is 504 participants. The study started on 2014-02. Estimated completion is 2015-01.
What interventions are being tested in trial NCT02252198?
The interventions under investigation include: Epistem Genedrive® and MolBio Truenat™ (OTHER).
Who is sponsoring clinical trial NCT02252198?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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