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
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...
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| 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 |
| author_facet | 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 |
| author_sort | Ursula Panzner |
| collection | DOAJ |
| description | 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 <18 years, is voluntary. Attestation by impartial witnesses is sought in case of illiteracy. Confidentiality of participants is being maintained throughout. Study findings will be presented at scientific conferences and published in peer-reviewed international journals.Trial registration number NCT04781257.Cite Now |
| format | Article |
| id | doaj-art-8e5324444e6a4d10a487d5a6da243a6b |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-8e5324444e6a4d10a487d5a6da243a6b2025-01-31T05:05:09ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2022-060985Early 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 studyUrsula Panzner0Katharina Kranzer1Tsitsi Bandason2Kuda MutasaSandra RukoboCharles SandyBariki Mtafya3Andrea RachowNorbert Heinrich4Michael HoelscherJudith Bruchfeld5Olena IvanovaNyanda Elias Ntinginya6Doreen PambaLaura OlbrichIssa SabiSimeon MwanyongaElmar SaathoffWillyhelmina OlomiJunior Mutsvangwa7Hazel M DockrellEdson Tawanda Marambire8Denise Banze9Alfred Mfinanga10Theodora D Mbunda11Khosa Celso12Gunilla Kallenius13Claire J Calderwood14Christof Geldmacher15Kathrin Held16Tejaswi Appalarowthu17Friedrich Rieß18Anna ShepherdChristopher SundlingMishelle MugavaMartha ChipinduroLwitiho SudiAntelmo HauleEmmanuel SichonePaschal QwarayHarrieth MwambolaLilian MinjaPeter EdwinDogo NgalisonStella LuswemaCelina NhamuaveAntónio MachianaCarla MadeiraEmelva ManhiçaNádia SitoeJorge Ribeiro19German Center for Infection Research (DZIF), Partner site Munich, Munich, GermanyClinical Research Department, London School of Hygiene & Tropical Medicine, London, UKThe Health Research Unit Zimbabwe at the Biomedical Research and Training Institute, Harare, Zimbabwe14 National Institute for Medical Research, Dar es Salaam, United Republic of TanzaniaDivision of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, Munich, GermanyDepartment of Infectious Disease, Karolinska University Hospital, Stockholm, Sweden14 National Institute for Medical Research, Dar es Salaam, United Republic of TanzaniaBiomedical Research and Training Institute, Harare, ZimbabweBiomedical Research and Training Institute, Harare, ZimbabweInstituto Nacional de Saúde, Marracuene, MozambiqueNational Institute for Medical Research- Mbeya Medical Research Centre, Mbeya, TanzaniaNational Institute for Medical Research- Mbeya Medical Research Centre, Mbeya, TanzaniaInstituto Nacional de Saúde, Marracuene, MozambiqueKarolinska Institutet, Stockholm, SwedenDepartment of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UKDivision of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, Munich, GermanyDivision of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, Munich, GermanyDivision of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, Munich, GermanyDivision of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich, Munich, GermanyCentro de Investigação e Treino em Saúde da Polana Caniço, Instituto Nacional de Saúde, Maputo, MozambiqueIntroduction 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 <18 years, is voluntary. Attestation by impartial witnesses is sought in case of illiteracy. Confidentiality of participants is being maintained throughout. Study findings will be presented at scientific conferences and published in peer-reviewed international journals.Trial registration number NCT04781257.Cite Nowhttps://bmjopen.bmj.com/content/12/7/e060985.full |
| spellingShingle | 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 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/12/7/e060985.full |
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