Status:
UNKNOWN
Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease
Lead Sponsor:
NanoPin Technologies, Inc.
Collaborating Sponsors:
Fortrea
Conditions:
Tuberculosis, Pulmonary
Tuberculosis, Extrapulmonary
Eligibility:
All Genders
2+ years
Brief Summary
The goal of this observational study is investigate the accuracy of the NanoDetect-TB kit in diagnosing tuberculosis (TB) using frozen serum and plasma samples collected from individuals suspected to ...
Eligibility Criteria
Inclusion
- Children and adults aged two years or older (including older adults that are 65+)
- Ability and willingness to provide informed consent/assent/permission, and a parent/legal guardian willing to give consent on the child's behalf for study participants aged 2-17 years
- Ability and willingness to perform study procedures, or parent/legal guardian to provide consent for a child to undergo study procedures on their behalf (when applicable)
- Clinical signs and symptoms typically associated with active TB disease including, but not limited to:
- Cough for \> two (2) weeks Lethargy, weakness, malaise Reduced playfulness (pediatric population) Weight loss or loss of appetite Failure to thrive (pediatric population) Fever Chest pain Night sweats
- Physician (or healthcare provider) suspicion of TB disease
Exclusion
- Pregnancy (based on participant-provided information)
- Any physical or mental health condition for which participation in the study, as judged by the investigator, could compromise the well-being of the subject and/or prevent, limit, or confound protocol-specified procedures
- Critical illness needing immediate medical care
- Receipt of treatment for active TB or LTBI in the past 24 months
Key Trial Info
Start Date :
August 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT05981495
Start Date
August 1 2023
End Date
December 1 2024
Last Update
August 8 2023
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