Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease

Tuberculosis, Pulmonary Clinical Trial

Official title:

Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05981495
• Other study ID #: NanoDetect-TB_01
• Status: Not yet recruiting
• Start date: August 2023
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: NanoPin Technologies, Inc.
• Contact: Thomas Tombler, Ph.D.
• Phone: 18056800377
• Email: ttombler[@]nanopintech.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 have TB disease.

The main question[s] it aims to answer are:

• How does this investigational device compare to the gold standard for TB diagnosis of sputum culture?

• How does it compare to Acid-Fast Bacteria (AFB) smear microscopy and FDA-approved NAAT TB diagnostic assays?

Participants will be asked to have blood drawn and provide demographic and medical data for this study in a single visit.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 460
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Extrapulmonary
• Tuberculosis, Pulmonary

Intervention

Device:
• NanoDetect-TB
This study of the NanoDetect-TB investigational device will test plasma and serum samples from TB suspects. There is no intervention for the subjects and there will be a single visit blood draw.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
NanoPin Technologies, Inc.	Fortrea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NanoDetect-TB result compared to sputum culture	The investigational device results will be compared to the primary reference of sputum culture for determining relative sensitivity and specificity.	Single visit for patient for blood draw.
Secondary	NanoDetect-TB result compared to AFB Smear and NAAT	The investigational device results will be further compared to the AFB Smear and NAAT for determining relative sensitivity and specificity.	Single visit for patient for blood draw.