Evidence map›Paper›PMID 41320215›Full record

ArticleBMJ open2025

Impact of drug-resistance diagnosis based on whole-genome sequencing on the treatment adequacy of patients with drug-resistant pulmonary tuberculosis in the state of São Paulo, Brazil: a protocol for a non-randomised controlled trial (Gen-TB PróCura).

Claudio Damião Rosa, Lucilaine Ferrazoli, Debora Pereira Dos Santos, Carolina Pedace, Naila Cristina Soler-Camargo, Taiana Tainá Silva-Pereira, Angela Pires Brandão, Valdes Roberto Bollela, Ana Luíza Gibertoni Cruz, Cinara Silva Feliciano and 13 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

23 authors.

Claudio Damião RosaDepartment of Microbiology, University of São Paulo Institute of Biomedical Sciences, São Paulo, Brazil.
Lucilaine FerrazoliTuberculosis and Mycobacteriosis Laboratory (NTM), Adolfo Lutz Institute, São Paulo, Brazil.
Debora Pereira Dos SantosTuberculosis and Mycobacteriosis Laboratory (NTM), Adolfo Lutz Institute, São Paulo, Brazil.
Carolina PedaceTuberculosis and Mycobacteriosis Laboratory (NTM), Adolfo Lutz Institute, São Paulo, Brazil.
Naila Cristina Soler-CamargoDepartment of Microbiology, University of São Paulo Institute of Biomedical Sciences, São Paulo, Brazil.
Taiana Tainá Silva-PereiraDepartment of Microbiology, University of São Paulo Institute of Biomedical Sciences, São Paulo, Brazil.
Angela Pires BrandãoTuberculosis and Mycobacteriosis Laboratory (NTM), Adolfo Lutz Institute, São Paulo, Brazil.
Valdes Roberto BollelaSchool of Medicine of Ribeirão Preto (FMRP), University of São Paulo, Ribeirão Preto, Brazil.
Ana Luíza Gibertoni CruzHealth Economics Research Centre, University of Oxford, Oxford, UK.
Cinara Silva FelicianoSchool of Medicine of Ribeirão Preto (FMRP), University of São Paulo, Ribeirão Preto, Brazil.
Paulo Roberto Abrão FerreiraDivision of Infectious Disease, School of Medicine, Federal University of São Paulo, Sao Paulo, Brazil.
Erika Plascak JorgeDivision of Infectious Disease, School of Medicine, Federal University of São Paulo, Sao Paulo, Brazil.
Silvana Spíndola de MirandaSchool of Medicine, Federal University of Minas Gerais, Belo Horizonte, Brazil.
Rosangela Siqueira de OliveiraTuberculosis and Mycobacteriosis Laboratory (NTM), Adolfo Lutz Institute, São Paulo, Brazil.
Maria de Lourdes Viude OliveiraTuberculosis Division, Center for Epidemiologic Vigilance "Prof Alexandre Vranjac", São Paulo State Secretariat of Health, São Paulo, Brazil.
Giovanna Mariah OrlandiTuberculosis Division, Center for Epidemiologic Vigilance "Prof Alexandre Vranjac", São Paulo State Secretariat of Health, São Paulo, Brazil.
Juliana Maira Watanabe PinhataTuberculosis and Mycobacteriosis Laboratory (NTM), Adolfo Lutz Institute, São Paulo, Brazil.
Mariângela Ribeiro ResendeDepartment of Clinical Medicine, School of Medical Sciences, State University of Campinas, Campinas, Brazil.ORCID http://orcid.org/0000-0001-7923-0076
Camila RodriguesEmilio Ribas Institute of Infectious Diseases, São Paulo, Brazil.
Roberta Karla Barbosa de SalesDepartment of Pneumology, School of Medicine, University of São Paulo, São Paulo, Brazil.
Sumire SakabeReference and Training Center on Sexually Transmitted Infections and AIDS (CRT-IST/AIDS) of the State of São Paulo, São Paulo, Brazil.
Erica ChimaraTuberculosis and Mycobacteriosis Laboratory (NTM), Adolfo Lutz Institute, São Paulo, Brazil anamarcia@usp.br erica.chimara@ial.sp.gov.br.
Ana Marcia Sa GuimaraesDepartment of Microbiology, University of São Paulo Institute of Biomedical Sciences, São Paulo, Brazil anamarcia@usp.br erica.chimara@ial.sp.gov.br.ORCID http://orcid.org/0000-0002-8261-5863

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSince 2018, WHO has endorsed the use of whole-genome sequencing (WGS) of METHODS AND ANALYSIS: We will conduct a non-randomised controlled clinical trial with two arms to compare the intervention group (ie, individuals receiving a WGS-based report) with a historical control group (i.e., individuals who received resistance diagnostics based on the standard of care of conventional genotyping and phenotyping techniques). The primary outcome will be the proportion of patients whose treatment scheme was adequate based on complete resistance profile determined by WGS and/or phenotypic drug-susceptibility testing (pDST). Other secondary outcomes will also be considered. The target sample size is 88 eligible patients per group. The intervention group will be prospectively recruited over 18 months and the control group will be composed of patients diagnosed with pulmonary DR-TB up to 2 years before the start of the trial. To ensure comparability, isolates from the control group will undergo WGS retrospectively, and pDST will be performed retrospectively in both groups. This clinical trial will take place in six medical centres for the treatment of DR-TB in the state of São Paulo. This study is intended to support the implementation of the WGS in the routine diagnosis of DR-TB in the state of São Paulo. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Human Research Committee of the Institute of Biomedical Sciences, University of São Paulo, Brazil (CAAE: 79497924.1.1001.5467). Study results will be published in peer-reviewed journals and disseminated to policymakers and stakeholders. TRIAL REGISTRATION NUMBER: U1111-1308-4669.

Indexed as

Antitubercular AgentsMycobacterium tuberculosisTuberculosis, Multidrug-ResistantTuberculosis, PulmonaryWhole Genome SequencingBrazilHumansNon-Randomized Controlled Trials as TopicAntitubercular Agentsclinical trialdiagnostic microbiologyinfectious diseasesmolecular diagnosticspublic healthtuberculosis

Identifiers

PMID41320215
PMCPMC12666065

What OpenQuestion holds

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Registered trials

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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.