학술논문
Early risk assessment in paediatric and adult household contacts of confirmed tuberculosis cases by novel diagnostic tests (ERASE-TB): protocol for a prospective, non-interventional, longitudinal, multicountry cohort study
Document Type
article
Author
Ursula Panzner; Katharina Kranzer; Tsitsi Bandason; Kuda Mutasa; Sandra Rukobo; Charles Sandy; Bariki Mtafya; Andrea Rachow; Norbert Heinrich; Michael Hoelscher; Judith Bruchfeld; Olena Ivanova; Nyanda Elias Ntinginya; Doreen Pamba; Laura Olbrich; Issa Sabi; Simeon Mwanyonga; Elmar Saathoff; Willyhelmina Olomi; Junior Mutsvangwa; Hazel M Dockrell; Edson Tawanda Marambire; Denise Banze; Alfred Mfinanga; Theodora D Mbunda; Khosa Celso; Gunilla Kallenius; Claire J Calderwood; Christof Geldmacher; Kathrin Held; Tejaswi Appalarowthu; Friedrich Rieß; Anna Shepherd; Christopher Sundling; Mishelle Mugava; Martha Chipinduro; Lwitiho Sudi; Antelmo Haule; Emmanuel Sichone; Paschal Qwaray; Harrieth Mwambola; Lilian Minja; Peter Edwin; Dogo Ngalison; Stella Luswema; Celina Nhamuave; António Machiana; Carla Madeira; Emelva Manhiça; Nádia Sitoe; Jorge Ribeiro
Source
BMJ Open, Vol 12, Iss 7 (2022)
Subject
Language
English
ISSN
2044-6055
Abstract
Introduction The WHO End-TB Strategy calls for the development of novel diagnostics to detect tuberculosis (TB) earlier and more accurately. Better diagnostics, together with tools to predict disease progression, are critical for achieving WHO End-TB targets. The Early Risk Assessment in TB Contacts by new diagnoStic tEsts (ERASE-TB) study aims to evaluate novel diagnostics and testing algorithms for early TB diagnosis and accurate prediction of disease progression among household contacts (HHCs) exposed to confirmed index cases in Mozambique, Tanzania and Zimbabwe.Methods and analysis A total of 2100 HHCs (aged ≥10 years) of adults with microbiologically-confirmed pulmonary TB will be recruited and followed up at 6-month intervals for 18–24 months. At each time point, a WHO symptom screen and digital chest radiograph (dCXR) will be performed, and blood and urine samples will be collected. Individuals screening positive (WHO symptom screen or dCXR) will be requested to provide sputum for Xpert MTB/Rif Ultra. At baseline, HHCs will also be screened for HIV, diabetes (HbA1c), chronic lung disease (spirometry), hypertension and anaemia. Study outcomes will be coprevalent TB (diagnosed at enrolment), incident TB (diagnosed during follow-up) or no TB at completion of follow-up. Novel diagnostics will be validated using fresh and biobanked samples with a nested case–control design. Cases are defined as HHCs diagnosed with TB (for early diagnosis) or with incident TB (for prediction of progression) and will be matched by age, sex and country to HHCs who remain healthy (controls). Statistical analyses will include assessment of diagnostic accuracy by constructing receiver operating curves and calculation of sensitivity and specificity.Ethics and dissemination ERASE-TB has been approved by regulatory and ethical committees in each African country and by each partner organisation. Consent, with additional assent for participants