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Clinical Trial [Version 1; Referees: 3 Approved] Ray Y Zurich Open Repository and Archive University of Zurich Main Library Strickhofstrasse 39 CH-8057 Zurich www.zora.uzh.ch Year: 2017 Using biomarkers to predict TB treatment duration (Predict TB): a prospective, randomized, noninferiority, treatment shortening clinical trial Chen, Ray Y ; Via, Laura E ; Dodd, Lori E ; Walzl, Gerhard ; Malherbe, Stephanus T ; Loxton, André G ; Dawson, Rodney ; Wilkinson, Robert J ; Thienemann, Friedrich ; Tameris, Michele ; Diacon, Andreas H ; Liu, Xin ; et al Abstract: Background: By the early 1980s, tuberculosis treatment was shortened from 24 to 6 months, maintaining relapse rates of 1-2%. Subsequent trials attempting shorter durations have failed, with 4- month arms consistently having relapse rates of 15-20%. One trial shortened treatment only among those without baseline cavity on chest x-ray and whose month 2 sputum culture converted to negative. The 4-month arm relapse rate decreased to 7% but was still significantly worse than the 6-month arm (1.6%, P<0.01). We hypothesize that PET/CT characteristics at baseline, PET/CT changes at one month, and markers of residual bacterial load will identify patients with tuberculosis who can be cured with 4 months (16 weeks) of standard treatment. Methods: This is a prospective, multicenter, randomized, phase 2b, noninferiority clinical trial of pulmonary tuberculosis participants. Those eligible start standard of care treatment. PET/CT scans are done at weeks 0, 4, and 16 or 24. Participants who do not meet early treatment completion criteria (baseline radiologic severity, radiologic response at one month, and GeneXpert-detectable bacilli at four months) are placed in Arm A (24 weeks of standard therapy). Those who meet the early treatment completion criteria are randomized at week 16 to continue treatment to week 24 (Arm B) or complete treatment at week 16 (Arm C). The primary endpoint compares the treatment success rate at 18 months between Arms B and C. Discussion: Multiple biomarkers have been assessed to predict TB treatment outcomes. This study uses PET/CT scans and GeneXpert (Xpert) cycle threshold to risk stratify participants. PET/CT scans are not applicable to global public health but could be used in clinical trials to stratify participants and possibly become a surrogate endpoint. If the Predict TB trial is successful, other immunological biomarkers or transcriptional signatures that correlate with treatment outcome may be identified. DOI: https://doi.org/10.12688/gatesopenres.12750.1 Posted at the Zurich Open Repository and Archive, University of Zurich ZORA URL: https://doi.org/10.5167/uzh-152419 Journal Article Published Version The following work is licensed under a Creative Commons: Attribution 4.0 International (CC BY 4.0) License. Originally published at: Chen, Ray Y; Via, Laura E; Dodd, Lori E; Walzl, Gerhard; Malherbe, Stephanus T; Loxton, André G; Dawson, Rodney; Wilkinson, Robert J; Thienemann, Friedrich; Tameris, Michele; Diacon, Andreas H; Liu, Xin; et al (2017). Using biomarkers to predict TB treatment duration (Predict TB): a prospective, randomized, noninferiority, treatment shortening clinical trial. Gates Open Research:1:9. DOI: https://doi.org/10.12688/gatesopenres.12750.1 2 Gates Open Research Gates Open Research 2017, 1:9 Last updated: 04 MAY 2018 STUDY PROTOCOL Using biomarkers to predict TB treatment duration (Predict TB): a prospective, randomized, noninferiority, treatment shortening clinical trial [version 1; referees: 3 approved] Ray Y. Chen1 , Laura E. Via 1,2 , Lori E. Dodd 3 , Gerhard Walzl 4 , Stephanus T. Malherbe4 , André G. Loxton 4 , Rodney Dawson 5 , Robert J. Wilkinson2,6,7 , Friedrich Thienemann 2,8 , Michele Tameris 9 , Mark Hatherill9 , Andreas H. Diacon 10 , Xin Liu 11 , Jin Xing 12 , Xiaowei Jin 13 , Zhenya Ma14 , Shouguo Pan 15 , Guolong Zhang 12 , Qian Gao 16 , Qi Jiang 16 , Hong Zhu17 , Lili Liang 10 , Hongfei Duan 18 , Taeksun Song 19 , David Alland 20 , Michael Tartakovsky21 , Alex Rosenthal 21 , Christopher Whalen 21 , Michael Duvenhage21 , Ying Cai 1 , Lisa C. Goldfeder 1 , Kriti Arora 1 , Bronwyn Smith 4 , Jill Winter22 , Clifton E. Barry III 1,2 , Predict TB Study Group 1Tuberculosis Research Section, Laboratory of Clinical Immunology and Microbiology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA 2Wellcome Centre for Infectious Diseases Research in Africa,Institute of Infectious Disease and Molecular Medicine, University of Cape Town (UCT), Cape Town, South Africa 3Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA 4South Africa Department of Science and Technology - National Research Foundation Centre of Excellence for Biomedical Tuberculosis Research, South African Medical Research Council Centre for Tuberculosis Research, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa 5Division of Pulmonology, Department of Medicine, University Of Cape Town Lung Institute, University of Cape Town (UCT), Cape Town, South Africa 6Francis Crick Institute, London, NW1 2AT, UK 7Department of Medicine, Imperial College London, London, W2 1PG, UK 8Department of Internal Medicine, University Hospital Zurich, Zurich, Switzerland 9South African Tuberculosis Vaccine Initiative, University of Cape Town (UCT), Cape Town, South Africa 10TASK Applied Science and Stellenbosch University, Cape Town, South Africa 11Henan Provincial Chest Hospital, Zhengzhou, Henan, China 12Henan Provincial Institute of Tuberculosis and Prevention, Henan Center for Disease Control, Zhengzhou, Henan, China 13Xinmi City Institute of Tuberculosis Prevention and Control, Xinmi, Henan, China 14Kaifeng City Institute of Tuberculosis Prevention and Control, Kaifeng, Henan, China 15Zhongmu County Health and Epidemic Prevention Station, Zhongmu, Henan, China 16Fudan University, Shanghai, China 17Sino-US Tuberculosis Collaborative Research Program, Zhengzhou, Henan, China 18Beijing Chest Hospital, Beijing, China 19Institute of Infectious Disease and Molecular Medicine, University of Cape Town (UCT), Cape Town, South Africa 20Division of Infectious Diseases, Department of Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA 21Office of Cyber Infrastructure and Computational Biology, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA 22Catalysis Foundation for Health, Emeryville, CA, USA Page 1 of 23 Gates Open Research Gates Open Research 2017, 1:9 Last updated: 04 MAY 2018 First published: 06 Nov 2017, 1 :9 (doi: 10.12688/gatesopenres.12750.1 ) Open Peer Review v1 Latest published: 06 Nov 2017, 1 :9 (doi: 10.12688/gatesopenres.12750.1 ) Referee Status: Abstract Background: By the early 1980s, tuberculosis treatment was shortened from 24 to 6 months, maintaining relapse rates of 1-2%. Subsequent trials Invited Referees attempting shorter durations have failed, with 4-month arms consistently having 1 2 3 relapse rates of 15-20%. One trial shortened treatment only among those without baseline cavity on chest x-ray and whose month 2 sputum culture version 1 converted to negative. The 4-month arm relapse rate decreased to 7% but was published report report report still significantly worse than the 6-month arm (1.6%, P<0.01). We hypothesize 06 Nov 2017 that PET/CT characteristics at baseline, PET/CT changes at one month, and markers of residual bacterial load will identify patients with tuberculosis who 1 Toyin Togun , McGill University, can be cured with 4 months (16 weeks) of standard treatment. Methods: This is a prospective, multicenter, randomized, phase 2b, Canada noninferiority clinical trial of pulmonary tuberculosis participants. Those eligible Emily MacLean , McGill University, start standard of care treatment. PET/CT scans are done at weeks 0, 4, and 16 Canada or 24. Participants who do not meet early treatment completion criteria (baseline radiologic severity, radiologic response at one month, and 2 Andrew J. Nunn, University College GeneXpert-detectable bacilli at four months) are placed in Arm A (24 weeks of London, UK standard therapy). Those who meet the early treatment completion criteria are Conor Tweed, University College London, randomized at week 16 to continue treatment to week 24 (Arm B) or complete UK treatment at week 16 (Arm C). The primary endpoint compares the treatment success rate at 18 months between Arms B and C. 3 Beth Shoshana Zha, University of Discussion: Multiple biomarkers have been assessed to predict TB treatment California, San Francisco, USA outcomes. This study uses PET/CT scans and GeneXpert (Xpert) cycle threshold to risk stratify participants. PET/CT scans are not applicable to global Payam Nahid, University of California, San public health but could be used in clinical trials to stratify participants and Francisco, USA possibly become a surrogate endpoint. If the Predict TB trial is successful, other immunological biomarkers or transcriptional signatures that correlate with Discuss this article treatment outcome may be identified. Trial Registration: NCT02821832 Comments (0) Keywords pulmonary tuberculosis, drug sensitive, PET/CT, GeneXpert, cycle threshold, treatment shortening, biomarkers, MERM Page 2 of 23 Gates Open Research Gates Open Research 2017, 1:9 Last updated: 04 MAY 2018 Corresponding author:
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