NCT04141982

Brief Summary

The objective is to achieve 90% overall, positive and negative clinical concordance between results of the T-SPOT.TB assay, using cells isolated via density gradient centrifugation and positive selection using the T-Cell Select kit, between 0-55 hours following venepuncture

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
680

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

November 4, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2020

Completed
Last Updated

March 3, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

October 25, 2019

Last Update Submit

March 2, 2022

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • Achieving positive and negative clinical concordance between results of the T-SPOT.TB assay between 0-55hours after venipuncture

    Achieving 90% overall, positive and negative clinical concordance between results of the T-SPOT.TB assay, using cells isolated via density gradient centrifugation and positive selection using the T-Cell Select kit, between 0-55 hours following venepuncture

    1 year

Study Arms (3)

Suspected of having TB infection

These donors are suspected of having TB infection and live in a high endemic area for TB infection

Diagnostic Test: T-Cell SelectTM Kit

No (or minimal) TB risk factors

These donors must have no previous medical record of TB infection and live in low endemic area for TB infection

Diagnostic Test: T-Cell SelectTM Kit

low/intermediate risk of TB infection population

These donors must live in an low/intermediate endemic area for TB infection

Diagnostic Test: T-Cell SelectTM Kit

Interventions

T-Cell SelectTM KitDIAGNOSTIC_TEST

The T-Cell Select kit is intended for the isolation of mononuclear immune cells from whole blood, using positive selection via a magnetic bead-based cell separation system, for use in the T-SPOT.TB assay.

No (or minimal) TB risk factorsSuspected of having TB infectionlow/intermediate risk of TB infection population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This evaluation will collect blood samples from subjects suspected of having TB infection and, samples from a low risk control population with no (or minimal) TB risk factors. All subjects presenting at participating clinics will be eligible for enrolment into the study provided they meet the inclusion/exclusion criteria outlined in section 4. Based on previous experience and the medical profile of the patient attending each of clinics at the four study sites, it is expected that the sites will individually, and collectively, yield a range of positive and negative assay results required to assess the impact of the T-Cell Select kit on positive and negative agreements of the T-SPOT.TB test.

You may qualify if:

  • Be able to provide informed consent
  • Be able to provide a minimum of 7 mL and maximum of 20 mL of whole blood.
  • Have suspected TB infection.
  • Be at least 18 years of age.
  • Live in a high endemic area for TB infection

You may not qualify if:

  • Be able to provide informed consent
  • Be able to provide a minimum of 7 mL and maximum of 20 mL of whole blood.
  • Have no suspicion TB infection.
  • Be at least 18 years of age.
  • Live in low endemic area for TB infection
  • Have no previous medical record of TB infection
  • Current/previous TB diagnosis
  • Be able to provide a minimum of 7 mL and maximum of 20 mL of whole blood.
  • Have no suspicion TB infection.
  • Be at least 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

NECCR Primacare Research, LLC

Fall River, Massachusetts, 02721, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Texas Health Science Center at Houston, School of Public Health in Brownsville

Brownsville, Texas, 78520, United States

Location

Rapitrade

Cape Town, South Africa

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Andre Trollip, PhD

    Rapitrade

    PRINCIPAL INVESTIGATOR

  • Blanca Restrepo, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

  • Ehab Sorial, MD

    NECCR Primacare Research, LLC

    PRINCIPAL INVESTIGATOR

  • Shu-Hua Wang, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2019

First Posted

October 28, 2019

Study Start

November 4, 2019

Primary Completion

March 18, 2020

Study Completion

March 18, 2020

Last Updated

March 3, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)ZA(1)