Evaluation of Host Biomarker-based Point-of-care Tests for Targeted Screening for Active TB

• Register: ClinicalTrials.gov
• Last refreshed on: 13 February 2023
• Main ID: NCT03350048
• Date of registration: 17/11/2017
• Prospective Registration: No
• Primary sponsor: Prof Gerhard Walzl
• Public title: Evaluation of Host Biomarker-based Point-of-care Tests for Targeted Screening for Active TB ScreenTB
• Scientific title: Evaluation of Host Biomarker-based Point-of-care Tests for Targeted Screening for Active TB
• Date of first enrolment: April 1, 2016
• Target sample size: 969
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03350048
• Study type: Observational

Countries of recruitment

Ethiopia, Gambia, Germany, Namibia, Netherlands, South Africa, Uganda, United Kingdom

Contacts

• Name: Gerhard Walzl, PhD, MD
• Affiliation: Head of Department of Biomedical Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

- Symptoms suggestive of TB disease: cough for more than two weeks with 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.

- Eighteen years or older and aged 70 years or younger.

Exclusion Criteria:

- Permanent residence in study area for less than 3 months or with no permanent address.

- Pregnancy or breastfeeding.

- HB<9g/l

- On TB treatment currently or in the last ninety days.

- HIV positive patients currently on INH prophylaxis, or in the last ninety days.

- Known quinolone or aminoglicozide antibiotic use reported in the past 60 days.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Tuberculosis

Intervention(s)

Diagnostic Test: Trans-Dot point-of-care test

Primary Outcome(s)

Diagnostic performance of the TransDot finger-prick test [Time Frame: 3 years]

Secondary Outcome(s)

Identification of additional host marker signatures [Time Frame: 3 years]

Biomarker Biorepository Samples [Time Frame: 3 years]

Optimisation of ultra-sensitive TB culture techniques [Time Frame: 3 years]

POC TransDOT test versus lab-based tests [Time Frame: 3 years]

Evaluation of the serum signature's underlying biological processes [Time Frame: 3 years]

TransDOT as treatment response marker [Time Frame: 3 years]

Secondary ID(s)

N16/05/070

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Armauer Hansen Research Institute, Ethiopia

Makerere University

London School of Hygiene and Tropical Medicine

Medical Research Council Unit, The Gambia

LINQ Management GMBH

European and Developing Countries Clinical Trials Partnership (EDCTP)

Leiden University Medical Center