N/A
Completed N=33
Evaluation of the QuantiFERON-TB Test.
Source: ClinicalTrials.gov NCT02142894 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity — 29 Participants
Summary
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity |
29 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical symptoms consistent with a high probability of having TB disease
- Receiving, or are likely to receive, therapy for active TB
- Confirmed tuberculosis by either AFB smear and culture testing, or Nucleic Acid Amplification methods and culture testing.
- Between 18 and 70 years of age.
Exclusion Criteria
- Taken therapy for active TB or latent TB for more than 14 days
- Culture confirmation of M. tuberculosis not obtained
Data sourced from ClinicalTrials.gov (NCT02142894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.