Triage test for all-oral drug-resistant tuberculosis (DR-TB) regimen: a phase IV study to assess effectiveness, feasibility, acceptability and cost-effectiveness of the Xpert MTB/XDR assay for rapid triage and treatment of DR-TB

被引：0

作者：

Naidoo, Kogieleum ^{[1
,2
]}

Naidoo, Anushka ^{[1
,2
]}

Abimiku, Alash'le G. ^{[3
,4
]}

Tiemersma, Everdina W. ^{[5
]}

Gebhard, Agnes ^{[5
]}

Hermans, Sabine M. ^{[6
]}

Sloan, Derek J. ^{[7
]}

Ruhwald, Morten ^{[8
]}

Georghiou, Sophia B. ^{[8
]}

Okpokoro, Evaezi ^{[3
]}

Agbaje, Aderonke ^{[3
]}

Yae, Kalkidan ^{[9
]}

Tollera, Getachew ^{[10
]}

Moga, Shewki ^{[10
]}

Feyt, Hannelise ^{[11
]}

Kachoka, Takondwa ^{[11
]}

Letsoalo, Marothi P. ^{[1
]}

Cabibbe, Andrea M. ^{[12
]}

Perumal, Rubeshan ^{[1
,2
]}

Shunmugam, Letitia ^{[1
,2
]}

Cirillo, Daniela M. ^{[12
]}

Foraida, Salah ^{[13
]}

Sabiiti, Wilber ^{[7
]}

Ntinginya, Nyanda Elias ^{[14
]}

Mtafya, Bariki ^{[14
]}

Bedru, Ahmed ^{[9
]}

Gillespie, Stephen H. ^{[7
]}

机构：

[1] Ctr Aids Programme Res South Africa, Durban, Kwazulu Natal, South Africa

[2] Univ KwaZulu Natal, Doris Duke Med Res Inst, SAMRC CAPRISA HIV TB Pathogenesis & Treatment Res, Durban, Kwazulu Natal, South Africa

[3] Inst Human Virol Nigeria, Int Res Ctr Excellence, Abuja, Nigeria

[4] Univ Maryland, Sch Med, Baltimore, MD USA

[5] Hotelsch The Hague, The Hague, Netherlands

[6] Univ Amsterdam, Amsterdam UMC Locat, Amsterdam Inst Global Hlth & Dev, Amsterdam UMC Locat, Amsterdam, Netherlands

[7] Univ St Andrews, St Andrews, Scotland

[8] Fdn Innovat New Diagnost, Geneva, Switzerland

[9] Ethiotelecom, Addis Ababa, Ethiopia

[10] Ethiopian Publ Hlth Inst, Addis Ababa, Ethiopia

[11] Wits Hlth Consortium Pty Ltd, Jose Pearson TB Hosp, Clin HIV Res Unit CHRU, Port Elizabeth, South Africa

[12] IRCCS Osped San Raffaele, Emerging Bacterial Pathogens, Milan, Italy

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

[14] Natl Inst Med Res, Dar Es Salaam, Tanzania

来源：

BMJ OPEN | 2024年 / 14卷 / 11期

关键词：

Molecular diagnostics; Tuberculosis; Observational Study; Public health; BACTERIAL LOAD ASSAY; MYCOBACTERIUM-TUBERCULOSIS; CULTURE;

D O I：

10.1136/bmjopen-2024-084722

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Introduction The TriAD study will assess the Xpert MTB/XDR (Xpert XDR; Cepheid) assay to detect tuberculosis (TB) drug resistance in sputum testing positive for TB to rapidly triage and treat patients with a short all-oral treatment regimen.Methods and analysis In this study, approximately 4800 Xpert MTB/RIF or Ultra MTB-positive patients (irrespective of rifampicin (RIF) resistance (RR) status) from several clinical sites across South Africa, Nigeria and Ethiopia will be enrolled over 18-24 months and followed-up for approximately 6 months post-TB treatment completion. Participants will be enrolled into one of two cohorts based on Xpert MTB/RIF and Xpert XDR results: Mycobacterium tuberculosis (M.tb) positive participants with RR in Cohort 1 (n=880) and M.tb positive RIF susceptible TB patients with isoniazid mono-resistance irrespective of presence of resistance to fluoroquinolones, second-line injectable drugs or ethionamide in Cohort 2 (n=400). Cohort 1 will be compared with historical cohorts from each implementing sites. The primary study outcomes include time to initiation of an appropriate treatment regimen by resistance profile and the proportion of patients with favourable treatment outcomes compared with historical cohorts from each of the implementing sites. Secondary outcomes include feasibility, acceptability and cost-effectiveness of this approach to inform policies and guidelines for programmatic implementation of this triage and treat model for drug-resistant tuberculosis management. Utility of the tuberculosis molecular bacterial load assay (TB-MBLA) for real-time treatment response assessment will also be evaluated.Ethics and dissemination The University of KwaZulu-Natal Biomedical Research Ethics Committee (BREC) and local research committees have provided ethical review and approval (BREC/00002654/2021, HREC 210805, NHREC/01/01/2007 and EPHI-IRB-459-2022). The South African Health Products Regulatory Authority (SAHPRA) have granted regulatory approval for the TRiAD Study (SAHPRA MD20211001). Trial results will be disseminated through conference presentations, peer-reviewed publications and the clinical trial registry.Trial registration number Clinicaltrials.gov; Trial registration number: NCT05175794; South African National Clinical Trials Register (SANCTR DOH-27-012022-4720)

引用

页数：11

共 1 条

[1] COST-EFFECTIVENESS OF BEDAQUILINE VERSUS INJECTABLE STANDARD-OF-CARE AGENTS FOR THE TREATMENT OF DRUG-RESISTANT TUBERCULOSIS (DR-TB) IN RUSSIA, INDIA, AND SOUTH AFRICA: BREAKTHROUGH INNOVATION DRIVING DOWN COST OF TREATMENT SUCCESS
Ionescu, A.
Agnarson, M. A.
Kambili, C.
Kfoury, J.
Steven, W.
Singh, V
Williams, A.
Thomas, A.
VALUE IN HEALTH, 2018, 21 : S411 - S411

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