Evidence map›Paper›PMID 39456079›Full record

ArticleTrials2024

Whole genome sequencing of M. tuberculosis for disease control in high-burden settings: study protocol for a cluster randomized controlled trial evaluating different community-wide intervention strategies in rural Madagascar.

Emmanuelle Sandra Adjoa Ametepe, Noela Andriamanoha, Fanantenana Randria Andrianomanana, Floriane Point, Reziky Tiandraza Mangahasimbola, Alina Dyachenko, Michael Hall, Theodora Mayouya Gamana, Astrid M Knoblauch, Yemimah Yededyah Razafindrasoa and 9 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05406453 (Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar - a Cluster Randomized Controlled Trial to Evaluate Different Community-wide Intervention Strategies.), which is not on this 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.

NCT05406453 nacompletednot on this map

Whole Genome Sequencing of Tuberculosis for Disease Control in Madagascar - a Cluster Randomized Controlled Trial to Evaluate Different Community-wide Intervention Strategies.

TypeinterventionalSponsorInstitut Pasteur de MadagascarRan2022 to 2024Enrolled98,362ConditionsTuberculosisArmsWhole Genome Sequencing testing
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

19 authors.

Emmanuelle Sandra Adjoa Ametepe *École de Santé Publique de L'Université de Montréal (ESPUM), Université de Montréal, Montréal, Canada.ORCID http://orcid.org/0000-0002-4400-8851
Noela Andriamanoha *Epidemiology Unit, Institut Pasteur de Madagascar, Ambohitrakely, Antananarivo, Madagascar.
Fanantenana Randria AndrianomananaMycobacteria Unit, Institut Pasteur de Madagascar, Ambohitrakely, Antananarivo, Madagascar.ORCID http://orcid.org/0009-0008-8713-6694
Floriane PointCentre de Recherche du Centre Hospitalier de L'Université de Montréal, Université de Montréal, Montréal, Canada.ORCID http://orcid.org/0000-0002-8757-2049
Reziky Tiandraza MangahasimbolaEpidemiology Unit, Institut Pasteur de Madagascar, Ambohitrakely, Antananarivo, Madagascar.ORCID http://orcid.org/0000-0002-6531-8736
Alina DyachenkoCentre de Recherche du Centre Hospitalier de L'Université de Montréal, Université de Montréal, Montréal, Canada.ORCID http://orcid.org/0000-0001-7705-5470
Michael HallEuropean Bioinformatics Institute (EMBL-EBI), Cambridgeshire, UK.ORCID http://orcid.org/0000-0003-3683-6208
Theodora Mayouya GamanaEpidemiology Unit, Institut Pasteur de Madagascar, Ambohitrakely, Antananarivo, Madagascar.ORCID http://orcid.org/0000-0002-3508-2486
Astrid M KnoblauchSwiss Tropical and Public Health Institute, Allschwil, Switzerland.ORCID http://orcid.org/0000-0001-5943-4362
Yemimah Yededyah RazafindrasoaEpidemiology Unit, Institut Pasteur de Madagascar, Ambohitrakely, Antananarivo, Madagascar.
Arianminpathy NimalanSchool of Public Health, Imperial College, London, England.ORCID http://orcid.org/0000-0001-9502-6876
Marcel BehrResearch Instituteof the, McGill University Health Center , Montreal, Canada.ORCID http://orcid.org/0000-0003-0402-4467
Madeleine DurandCentre de Recherche du Centre Hospitalier de L'Université de Montréal, Université de Montréal, Montréal, Canada.
Mira JohriÉcole de Santé Publique de L'Université de Montréal (ESPUM), Université de Montréal, Montréal, Canada.ORCID http://orcid.org/0000-0001-5642-787X
Zamin IqbalEuropean Bioinformatics Institute (EMBL-EBI), Cambridgeshire, UK.ORCID http://orcid.org/0000-0001-8466-7547
Andry Rivo RakotoariveloDepartment of Medicine, Université de Montréal, Montréal, Canada.ORCID http://orcid.org/0000-0003-3438-8624
Rindra Vatosoa RandremananaEpidemiology Unit, Institut Pasteur de Madagascar, Ambohitrakely, Antananarivo, Madagascar.ORCID http://orcid.org/0000-0002-6174-8827
Niaina RakotosamimananaMycobacteria Unit, Institut Pasteur de Madagascar, Ambohitrakely, Antananarivo, Madagascar.ORCID http://orcid.org/0000-0002-2352-9797
Simon Grandjean LapierreCentre de Recherche du Centre Hospitalier de L'Université de Montréal, Université de Montréal, Montréal, Canada. simon.grandjean.lapierre@umontreal.ca.ORCID http://orcid.org/0000-0003-3646-1573

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRetrospective and descriptive molecular epidemiology studies have shown that Mycobacterium tuberculosis whole genome sequencing can identify outbreaks and disease transmission events with higher resolution than conventional epidemiological investigations. Those studies have strengthened our understanding of genomic polymorphisms correlating with person-to-person transmission and helped resolve putative transmission clusters. To date, systematic genomic surveillance programs implemented for M. tuberculosis were only implemented in low-incidence settings. The purpose of this study is to determine whether there is an impact of routine M. tuberculosis whole genome sequencing on tuberculosis case detection in a high-incidence setting.

methodsA cluster randomized controlled trial will be performed. Forty-eight rural village groups (or Fokontany) in the Vohibato district of Madagascar will be randomized to one of three interventions arms. Arm 1 (standard of care) involves healthcare facility-based passive case detection with smear microscopy testing. Arm 2 (best practice) consists of active case finding and Xpert MTB/RIF Ultra PCR testing followed by household contact investigations. Arm 3 (novel intervention) includes the same interventions as arm 2, with addition of sputum culture and M. tuberculosis whole genome sequencing for all newly diagnosed cases. In arm 3, molecular suggested putative outbreaks are investigated, and additional TB suspects are appropriately tested. The intervention observational period will be 2 years. The primary outcome will be the number of detected cases/100,000/year in each arm after 1 year of intervention. DISCUSSION: This study is designed to determine whether there is an impact of prospective whole genome sequencing-based molecular typing on tuberculosis case detection in high-incidence settings. Investigating potential outbreaks and focusing active case finding in spatiotemporal settings where disease transmission is suggested by genomic typing is hypothesized to improve case detection in rural communities.

trial registrationClinicalTrials.gov NCT05406453 . Retrospectively registered on June 6, 2022.

Indexed as

Mycobacterium tuberculosisRandomized Controlled Trials as TopicWhole Genome SequencingHumansIncidenceMadagascarSputumTuberculosisCluster randomized controlled trialDisease outbreakMolecular epidemiologyTuberculosisWhole genome sequencing

Identifiers

PMID39456079
PMCPMC11515128

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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.