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Point-of-care Triage Test for Active Tuberculosis (TriageTB)

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ClinicalTrials.gov Identifier: NCT04232618
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
Makerere University
Find
Leiden University Medical Center
Medical Research Council Unit, The Gambia
LINQ Management GMBH
Information provided by (Responsible Party):
Prof Gerhard Walzl, University of Stellenbosch

Brief Summary:

Background:

Tuberculosis (TB) is a bacterial lung infection leaving 3.6 million people undiagnosed each year. Thirty percent of infected people do not receive treatment due to failure to receive diagnostic testing or being lost to follow-up between testing and availability of results.

Objective:

To refine and field-validate a point-of-care (POC) finger stick blood test for use worldwide to triage for active TB.

Eligibility:

Persons aged 15 - 70 years with symptoms suggestive of TB disease

Study design:

Participants will be screened with:

Medical history Physical exam HIV test, diabetes screening Blood (finger stick and venous), sputum and urine collection Chest X-ray TB positive participants will receive treatment from the National TB Program at Community Health Centres and clinics.


Condition or disease Intervention/treatment
Tuberculosis Tuberculosis, Pulmonary Diagnostic Test: Multi-biomarker point-of-care test

Detailed Description:

This study aims to make widely available an inexpensive, easy to use point-of-care finger stick test to triage patients presenting with signs and symptoms consistent with active TB. From previous experience in EDCTP-funded studies, approximately 30% of such patients test positive for TB, with the vast majority having respiratory illnesses other than active TB, including acute upper or lower respiratory tract infections or exacerbations of chronic obstructive pulmonary disease. The proposed finger stick test is designed, with the aim of use, as a TB rule out test such that resources required for further testing can be used with more efficiency.

The majority (60%) of suspected TB cases are seen at public health facilities, however many facilities in high TB prevalence areas still do not have access to efficient TB diagnostic services due to logistical and financial constraints that plague these settings. Currently available diagnostics include radiological and microbiological testing, though each has drawbacks for use in primary care facilities.

The TriageTB consortium will be evaluating combinations of biomarkers in samples from African and Non-African individuals suspected of having TB in order to identify the optimal biomarker signature for global identification of patients with high likelihood of TB. A device has been developed, which measures a combination of biomarkers in finger stick capillary blood and has been validated in the laboratory setting. Previous EDCTP-funded projects identified a promising 6-marker biosignature which has been shown to have potential for being reduced to a 3- or 4- marker signature. The 3-marker signature has the added benefit of potential for treatment monitoring applications. A triage test as proposed here would significantly speed up and streamline diagnostic approaches in resource-limited settings.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Field Evaluation of a Point-of-care Triage Test for Active Tuberculosis
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Group/Cohort Intervention/treatment
FIND cohort
Evaluation of biomarkers in serum samples from 500 people with suspected TB from non-African countries provided by FIND diagnostic biorepository.
Phase 1
Evaluate the basic 3-marker multi-biomarker test (MBT) signature in 300 participants across three African sites. This will be used to lock down the final MBT signature to be used in the next phase of testing.
Diagnostic Test: Multi-biomarker point-of-care test
Lateral flow device containing a combination of markers which have been shown to be associated with active tuberculosis.

Phase 2
Enrolment of 600 participants across three African sites using the locked down MBT signature from phase 1.
Diagnostic Test: Multi-biomarker point-of-care test
Lateral flow device containing a combination of markers which have been shown to be associated with active tuberculosis.




Primary Outcome Measures :
  1. Global diagnostic bio-signature for diagnosing active TB [ Time Frame: 4 years ]
    Accuracy of a point-of-care multi-biomarker test (POC-MBT) in active, pulmonary tuberculosis.


Secondary Outcome Measures :
  1. Use of MBT for treatment response [ Time Frame: 4 years ]
    Accuracy of the point-of-care multi-biomarker test as an indicator of tuberculosis treatment outcome.


Biospecimen Retention:   Samples With DNA
Finger stick capillary blood for POC test strip, Serum collection and storage, Whole blood collection for isolation of peripheral blood mononuclear cells (PBMCs), PAXgene collection for storage of mRNA, Sputum for testing and storage, Urine for storage


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants are recruited from known TB endemic areas across three African countries.
Criteria

Inclusion Criteria:

  • Symptoms suggestive of TB disease: cough for more than two weeks plus at least one of the following: fever, malaise, weight loss, night sweats, haemoptysis, chest pain or loss of appetite.
  • Willingness to give consent to take part in the study.
  • Willingness to undergo HIV testing or be willing to have their HIV infection status disclosed to the study field workers.
  • Aged 18 to 70 years.

Participants who had previous TB, extra-pulmonary TB in addition to pulmonary TB, drug resistance detected on GeneXpert® or culture or other concomitant diseases, will not be excluded from enrolment. Both HIV positive and HIV negative individuals will be enrolled. Potential re-treatment cases with positive GeneXpert® tests will be carefully evaluated, as it is known that GeneXpert® can give false positive results in these patients.

Exclusion Criteria:

  • Permanent residence in study area for less than 3 months or with no permanent address.
  • Pregnancy or breastfeeding.
  • HB<9g/l.
  • Chronic systemic steroid use.
  • On TB treatment currently or in the last ninety days.
  • Known quinolone or aminoglycoside antibiotic use reported in the past 60 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04232618


Contacts
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Contact: Stephanus Malherbe, MBCHB, PhD +27 21 938 9646 malherbe@sun.ac.za
Contact: Bronwyn Smith, MSc +27 21 938 9646 bronwynt@sun.ac.za

Sponsors and Collaborators
University of Stellenbosch
London School of Hygiene and Tropical Medicine
Makerere University
Find
Leiden University Medical Center
Medical Research Council Unit, The Gambia
LINQ Management GMBH
Investigators
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Principal Investigator: Gerhard Walzl, MBCHB; PhD University of Stellenbosch
Additional Information:
Publications:
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Responsible Party: Prof Gerhard Walzl, Executive Head of Department of Biomedical Sciences, University of Stellenbosch
ClinicalTrials.gov Identifier: NCT04232618    
Other Study ID Numbers: RIA2018D-2499
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections