Tuberculosis, PulmonaryNCT05981495
Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease
An observational study of Tuberculosis, Pulmonary and Tuberculosis, Extrapulmonary, run by NanoPin Technologies, Inc..
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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Tuberculosis, Pulmonary, Tuberculosis, Extrapulmonary, Tuberculosis Active
- What is being tested?
- NanoDetect-TB
- Type of treatment
- Medical device
- How many people
- 460 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: TB suspects at clinical sites for recruitment in Houston, Miami, and New York City.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Being tested
- NanoDetect-TB
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis, Extrapulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoDetect-TBDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TB Suspects | TB Suspects recruited to this study will have blood drawn in a single visit. Receives: Device: NanoDetect-TB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single visit for patient for blood draw.
Secondary outcomes (1)
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.
Measured: Single visit for patient for blood draw.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NanoPin Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981495
- Sponsor's protocol ID
- NanoDetect-TB_01
- Status last verified
- Jul 2023
- First submitted
- 31 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease
- ClinicalTrials.gov ID
- NCT05981495
- Acronym / sponsor ID
- NanoDetect-TB_01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- NanoPin Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Study start
- Aug 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TB Suspects | – | Device: NanoDetect-TBTB Suspects recruited to this study will have blood drawn in a single visit. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- TB suspects at clinical sites for recruitment in Houston, Miami, and New York City.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NanoDetect-TBThis 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. | Device | TB Suspects |
Primary outcome
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.
1 secondary outcome
NanoDetect-TB result compared to AFB Smear and NAAT
Time frame: Single visit for patient for blood draw.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, Pulmonary and Tuberculosis, Extrapulmonary, run by NanoPin Technologies, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Tombler, Ph.D. (18056800377, ttombler@nanopintech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NanoDetect-TB result compared to sputum culture (time frame: Single visit for patient for blood draw.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.