Evidence map›Paper›PMID 39609025›Full record

ArticleBMJ open2024

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.

Kogieleum Naidoo, Anushka Naidoo, Alash'le G Abimiku, Everdina W Tiemersma, Agnes Gebhard, Sabine M Hermans, Derek J Sloan, Morten Ruhwald, Sophia B Georghiou, Evaezi Okpokoro and 18 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05175794 (Phase 4 Operational Study to Assess the Effectiveness, Feasibility, Acceptability, and Cost-effectiveness of the GeneXpert MTB/XDR), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05175794 completednot on this map

Phase 4 Operational Study to Assess the Effectiveness, Feasibility, Acceptability, and Cost-effectiveness of the GeneXpert MTB/XDR (Xpert XDR; Cepheid) Assay for Rapid Triage-and-treatment of DR-TB

TypeobservationalSponsorCentre for the AIDS Programme of Research in South AfricaRan2022 to 2025Enrolled786ConditionsDrug Resistant Tuberculosis, MDR-TB, XDR-TB, TuberculosisArmsXpert® MTB/XDR
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

Kogieleum NaidooCentre for the Aids Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa Kogie.Naidoo@caprisa.org.
Anushka NaidooCentre for the Aids Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa.ORCID http://orcid.org/0000-0001-9550-9501
Alash'le G AbimikuInternational Research Center of Excellence, Institute of Human Virology Nigeria, Abuja, Nigeria.
Everdina W TiemersmaKoninklijke Nederlandse Centrale Vereniging tot Bestrijding der Tuberculose, The Hague, The Netherlands.ORCID http://orcid.org/0000-0002-2071-3038
Agnes GebhardKoninklijke Nederlandse Centrale Vereniging tot Bestrijding der Tuberculose, The Hague, The Netherlands.
Sabine M HermansAmsterdam UMC location University of Amsterdam, Department of Global Health, Amsterdam Institute for Global Health and Development, Amsterdam, The Netherlands.
Derek J SloanUniversity of St Andrews, St Andrews, UK.
Morten RuhwaldFoundation for Innovative New Diagnostics, Geneva, Switzerland.
Sophia B GeorghiouFoundation for Innovative New Diagnostics, Geneva, Switzerland.
Evaezi OkpokoroInternational Research Center of Excellence, Institute of Human Virology Nigeria, Abuja, Nigeria.
Aderonke AgbajeInternational Research Center of Excellence, Institute of Human Virology Nigeria, Abuja, Nigeria.
Kalkidan YaeKoninklijke Nederlandse Centrale Vereniging tot Bestrijding der Tuberculose, Addis Ababa, Ethiopia.
Getachew TolleraEthiopian Public Health Institute, Addis Ababa, Ethiopia.
Shewki MogaEthiopian Public Health Institute, Addis Ababa, Ethiopia.
Hannelise FeytClinical HIV Research Unit (CHRU), Jose Pearson TB Hospital, Wits Health Consortium Pty Ltd, Port Elizabeth, South Africa.
Takondwa KachokaClinical HIV Research Unit (CHRU), Jose Pearson TB Hospital, Wits Health Consortium Pty Ltd, Port Elizabeth, South Africa.
Marothi P LetsoaloCentre for the Aids Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa.
Andrea M CabibbeEmerging bacterial pathogens, Ospedale San Raffaele, Milano, Italy.
Rubeshan PerumalCentre for the Aids Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa.
Letitia ShunmugamCentre for the Aids Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa.ORCID http://orcid.org/0000-0002-5192-0072
Daniela M CirilloEmerging bacterial pathogens, Ospedale San Raffaele, Milano, Italy.
Salah ForaidaGlobal Alliance for TB Drug Development, New York, New York, USA.
Wilber SabiitiUniversity of St Andrews, St Andrews, UK.ORCID http://orcid.org/0000-0002-4742-2791
Nyanda Elias NtinginyaNational Institute for Medical Research, Dar es Salaam, United Republic of Tanzania.
Bariki MtafyaNational Institute for Medical Research, Dar es Salaam, United Republic of Tanzania.
Ahmed BedruKoninklijke Nederlandse Centrale Vereniging tot Bestrijding der Tuberculose, Addis Ababa, Ethiopia.
Stephen H GillespieUniversity of St Andrews, St Andrews, UK.
TRiAD Study Consortium

Funding

Dolutegravir for the treatment of HIV in patients with Tuberculosis in KwaZulu-Natal South AfricaK43TW011437 · FIC · CENTRE/AIDS PROGRAMME/RES/SOUTH AFRICA · PI NAIDOO, ANUSHKA · 2019 to 2023
$616k
FIC NIH HHS K43 TW011437
6 · The paper itself

Abstract

introductionThe 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: 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).

Indexed as

Antitubercular AgentsCost-Benefit AnalysisMycobacterium tuberculosisSputumTriageTuberculosis, Multidrug-ResistantAdministration, OralAdultEthiopiaExtensively Drug-Resistant TuberculosisFeasibility StudiesHumansNigeriaRifampinSouth AfricaAntitubercular AgentsRifampinMolecular diagnosticsObservational StudyPublic healthTuberculosis

Identifiers

PMID39609025
PMCPMC11603726

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.