Status:
COMPLETED
Evaluation of Host Biomarker-based Point-of-care Tests for Targeted Screening for Active TB
Lead Sponsor:
Prof Gerhard Walzl
Collaborating Sponsors:
Armauer Hansen Research Institute, Ethiopia
Medical Research Council Unit, The Gambia
Conditions:
Pulmonary Tuberculosis
Eligibility:
All Genders
18-70 years
Brief Summary
Title: Evaluation of host biomarker-based point-of-care tests for targeted screening for active TB (Screen TB) Introduction: Tuberculosis (TB) places severe pressure on health care services of the de...
Detailed Description
Protocol Summary Title: Evaluation of host biomarker-based point-of-care tests for targeted screening for active TB (Screen TB) Population: A total of 800 people presenting at primary health care cli...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2020
Estimated Enrollment :
969 Patients enrolled
Trial Details
Trial ID
NCT03350048
Start Date
April 1 2016
End Date
July 31 2020
Last Update
February 1 2023
Active Locations (10)
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1
Armauer Hansen Research Institute
Addis Ababa, Ethiopia
2
European Research and Project Office GmbH
Saarbrücken, Saarland, Germany, 66123
3
LINQ Management GmbH
Berlin, Germany, 14057
4
University of Namibia
Windhoek, Namibia, 13301