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

July 31, 2023 updated by: NanoPin Technologies, Inc.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

460

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

TB suspects at clinical sites for recruitment in Houston, Miami, and New York City.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TB Suspects
TB Suspects recruited to this study will have blood drawn in a single visit.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NanoDetect-TB result compared to sputum culture
Time Frame: Single visit for patient for blood draw.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
NanoDetect-TB result compared to AFB Smear and NAAT
Time Frame: Single visit for patient for blood draw.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NanoPin Technologies, Inc.

Collaborators

Fortrea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NanoDetect-TB_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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