Study Title :Early risk assessment in TB contacts by new diagnostic tests

Principal Investigator(s)

Prof Katharina Kranzer, Dr Junior Mutsvanga, Dr Norbert Heinrich,Dr Celso Khosa

Funder(s)

European & Developing Countries Clinical Trials Partnership (EDCPT), German

Canter for Infection Research (DZIF)

Partner(s)

London School of Hygiene and Tropical Medicine, Mbeya Medical Research

Centre, Karolinska Institute, Medical centre of the University of Munich, Instituto Nacional

de Saúde, Cepheid, Biomerieux, Beckman Coulter, SD Biosensor, Ministry of Health and

Child Care Zimbabwe, Harare City Health, National TB Program Zimbabwe

Background

Tuberculosis is responsible for almost 1.5 million deaths every year, with sub-Saharan Africa

accounting for around a third of them. Globally an estimated 4 million people with

tuberculosis go undiagnosed each year. Late diagnosis can lead to extensive lung damage,

with long-term consequences for peoples’ respiratory health, and onward transmission.

Project aim

To validate novel diagnostics for early diagnosis of tuberculosis

Study design

ERASE-TB is a multi-country prospective cohort study implemented in three Southern African countries (Mozambique, Tanzania and Zimbabwe). A total of 2108 household contacts of 903 people diagnosed with tuberculosis were enrolled in the study and followed every 6 months for a maximum of 24 months. At each visit participants are screened for TB, novel diagnostic tests are performed and samples are bio banked for future testing. Primary outcome will be microbiologically confirmed tuberculosis at baseline or during follow-up.

Duration

February 2021 to January 2025.