Drug-resistant tuberculosis clinical trials: proposed core research definitions in adults

被引：16

作者：

Furin, J. ^{[1
]}

Alirol, E. ^{[2
]}

Allen, E. ^{[3
]}

Fielding, K. ^{[3
]}

Merle, C. ^{[3
]}

Abubakar, I. ^{[4
]}

Andersen, J. ^{[5
]}

Davies, G. ^{[6
]}

Dheda, K. ^{[7
]}

Diacon, A. ^{[8
]}

Dooley, K. E. ^{[9
]}

Dravnice, G. ^{[10
]}

Eisenach, K. ^{[11
]}

Everitt, D. ^{[12
]}

Ferstenberg, D. ^{[13
]}

Goolam-Mahomed, A. ^{[14
]}

Grobusch, M. P. ^{[15
]}

Gupta, R. ^{[16
]}

Harausz, E. ^{[1
]}

Harrington, M. ^{[17
]}

Horsburgh, C. R. ^{[18
]}

Lienhardt, C. ^{[19
]}

McNeeley, D. ^{[20
]}

Mitnick, C. D. ^{[21
]}

Nachman, S. ^{[22
]}

Nahid, P. ^{[23
]}

Nunn, A. J. ^{[24
]}

Phillips, P. ^{[24
]}

Rodriguez, C. ^{[25
]}

Shah, S. ^{[21
]}

Wells, C. ^{[16
]}

Thomas-Nyang'wa, B. ^{[2
]}

du Cros, R. ^{[2
]}

机构：

[1] Case Western Reserve Univ, Sch Med, TB Res Unit, Room E-202,2210 Circle Dr, Cleveland, OH 44149 USA

[2] Manson Unit Med Sans Frontieres, London, England

[3] London Sch Hyg & Trop Med, Infect Dis, London WC1, England

[4] UCL, Dept Infect & Populat Hlth, London, England

[5] Harvard Univ, Sch Publ Hlth, Stat & Data Anal Ctr, 665 Huntington Ave, Boston, MA 02115 USA

[6] Univ Liverpool, Inst Infect & Global Hlth & Translat Med, Liverpool L69 3BX, Merseyside, England

[7] Univ Cape Town, Dept Med, Groote Schuur Hosp, ZA-7925 Cape Town, South Africa

[8] Univ Stellenbosch, Fac Hlth Sci, Biomed Sci, ZA-7505 Tygerberg, South Africa

[9] Johns Hopkins Sch Med, Dept Med, Baltimore, MD USA

[10] KNCV, TB Fdn, Amsterdam, Netherlands

[11] Univ Arkansas Med Sci, Pathol & Microbiol, Little Rock, AR 72205 USA

[12] Global Alliance TB Drug Dev, New York, NY USA

[13] Sequella, Rockville, MD USA

[14] Univ Limpopo, TB Unit, Sovenga, South Africa

[15] Univ Amsterdam, Acad Med Ctr, Dept Infect Dis, Meibergdreef 9, NL-1105 AZ Amsterdam, Netherlands

[16] Otsuka USA, Rockville, MD USA

[17] Treatment Act Grp, New York, NY USA

[18] Boston Univ, Sch Publ Hlth, Dept Epidemiol, Boston, MA USA

[19] WHO, Stop TB Partnership & Stop TB Dept, Geneva, Switzerland

[20] Med Serv Corp Int, Arlington, VA USA

[21] Harvard Univ, Sch Med, Dept Global Hlth & Social Med, Boston, MA USA

[22] Stony Brook Sch Med, Dept Pediat, Stony Brook, NY USA

[23] Univ Calif San Francisco, San Francisco Gen Hosp, Curry Int TB Ctr, San Francisco, CA USA

[24] UCL, Med Res Council, Clin Trials Unit, Inst Clin Trials & Methodol, London, England

[25] PD Hinduja Natl Hosp, Dept Resp Med, Mumbai, Maharashtra, India

来源：

INTERNATIONAL JOURNAL OF TUBERCULOSIS AND LUNG DISEASE | 2016年 / 20卷 / 03期

基金：

英国医学研究理事会;

关键词：

drug-resistant tuberculosis; research; definitions;

D O I：

10.5588/ijtld.15.0490

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

Drug-resistant tuberculosis (DR-TB) is a growing public health problem, and for the first time in decades, new drugs for the treatment of this disease have been developed. These new drugs have prompted strengthened efforts in DR-TB clinical trials research, and there are now multiple ongoing and planned DR-TB clinical trials. To facilitate comparability and maximise policy impact, a common set of core research definitions is needed, and this paper presents a core set of efficacy and safety definitions as well as other important considerations in DR-TB clinical trials work. To elaborate these definitions, a search of clinical trials registries, published manuscripts and conference proceedings was undertaken to identify groups conducting trials of new regimens for the treatment of DR-TB. Individuals from these groups developed the core set of definitions presented here. Further work is needed to validate and assess the utility of these definitions but they represent an important first step to ensure there is comparability in clinical trials on multidrug-resistant TB.

引用

页码：290 / 294

页数：5

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