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.
| Title: | 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. |
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| Authors: | Ametepe, Emmanuelle Sandra Adjoa, Andriamanoha, Noela, Andrianomanana, Fanantenana Randria, Point, Floriane, Mangahasimbola, Reziky Tiandraza, Dyachenko, Alina, Hall, Michael, Gamana, Theodora Mayouya, Knoblauch, Astrid M., Razafindrasoa, Yemimah Yededyah, Nimalan, Arianminpathy, Behr, Marcel, Durand, Madeleine, Johri, Mira, Iqbal, Zamin, Rakotoarivelo, Andry Rivo, Randremanana, Rindra Vatosoa, Rakotosamimanana, Niaina, Lapierre, Simon Grandjean |
| Source: | Trials; 10/25/2024, Vol. 25 Issue 1, p1-9, 9p |
| Subject Terms: | CLUSTER randomized controlled trials, WHOLE genome sequencing, MYCOBACTERIUM tuberculosis, INFECTIOUS disease transmission, MOLECULAR epidemiology, TUBERCULOSIS |
| Abstract: | Background: Retrospective 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. Methods: A 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 registration: ClinicalTrials.gov NCT05406453. Retrospectively registered on June 6, 2022. [ABSTRACT FROM AUTHOR] |
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| Database: | Complementary Index |
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| Items | – Name: Title Label: Title Group: Ti Data: 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. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Ametepe%2C+Emmanuelle+Sandra+Adjoa%22">Ametepe, Emmanuelle Sandra Adjoa</searchLink><br /><searchLink fieldCode="AR" term="%22Andriamanoha%2C+Noela%22">Andriamanoha, Noela</searchLink><br /><searchLink fieldCode="AR" term="%22Andrianomanana%2C+Fanantenana+Randria%22">Andrianomanana, Fanantenana Randria</searchLink><br /><searchLink fieldCode="AR" term="%22Point%2C+Floriane%22">Point, Floriane</searchLink><br /><searchLink fieldCode="AR" term="%22Mangahasimbola%2C+Reziky+Tiandraza%22">Mangahasimbola, Reziky Tiandraza</searchLink><br /><searchLink fieldCode="AR" term="%22Dyachenko%2C+Alina%22">Dyachenko, Alina</searchLink><br /><searchLink fieldCode="AR" term="%22Hall%2C+Michael%22">Hall, Michael</searchLink><br /><searchLink fieldCode="AR" term="%22Gamana%2C+Theodora+Mayouya%22">Gamana, Theodora Mayouya</searchLink><br /><searchLink fieldCode="AR" term="%22Knoblauch%2C+Astrid+M%2E%22">Knoblauch, Astrid M.</searchLink><br /><searchLink fieldCode="AR" term="%22Razafindrasoa%2C+Yemimah+Yededyah%22">Razafindrasoa, Yemimah Yededyah</searchLink><br /><searchLink fieldCode="AR" term="%22Nimalan%2C+Arianminpathy%22">Nimalan, Arianminpathy</searchLink><br /><searchLink fieldCode="AR" term="%22Behr%2C+Marcel%22">Behr, Marcel</searchLink><br /><searchLink fieldCode="AR" term="%22Durand%2C+Madeleine%22">Durand, Madeleine</searchLink><br /><searchLink fieldCode="AR" term="%22Johri%2C+Mira%22">Johri, Mira</searchLink><br /><searchLink fieldCode="AR" term="%22Iqbal%2C+Zamin%22">Iqbal, Zamin</searchLink><br /><searchLink fieldCode="AR" term="%22Rakotoarivelo%2C+Andry+Rivo%22">Rakotoarivelo, Andry Rivo</searchLink><br /><searchLink fieldCode="AR" term="%22Randremanana%2C+Rindra+Vatosoa%22">Randremanana, Rindra Vatosoa</searchLink><br /><searchLink fieldCode="AR" term="%22Rakotosamimanana%2C+Niaina%22">Rakotosamimanana, Niaina</searchLink><br /><searchLink fieldCode="AR" term="%22Lapierre%2C+Simon+Grandjean%22">Lapierre, Simon Grandjean</searchLink> – Name: TitleSource Label: Source Group: Src Data: Trials; 10/25/2024, Vol. 25 Issue 1, p1-9, 9p – Name: Subject Label: Subject Terms Group: Su Data: <searchLink fieldCode="DE" term="%22CLUSTER+randomized+controlled+trials%22">CLUSTER randomized controlled trials</searchLink><br /><searchLink fieldCode="DE" term="%22WHOLE+genome+sequencing%22">WHOLE genome sequencing</searchLink><br /><searchLink fieldCode="DE" term="%22MYCOBACTERIUM+tuberculosis%22">MYCOBACTERIUM tuberculosis</searchLink><br /><searchLink fieldCode="DE" term="%22INFECTIOUS+disease+transmission%22">INFECTIOUS disease transmission</searchLink><br /><searchLink fieldCode="DE" term="%22MOLECULAR+epidemiology%22">MOLECULAR epidemiology</searchLink><br /><searchLink fieldCode="DE" term="%22TUBERCULOSIS%22">TUBERCULOSIS</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Background: Retrospective 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. Methods: A 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 registration: ClinicalTrials.gov NCT05406453. Retrospectively registered on June 6, 2022. [ABSTRACT FROM AUTHOR] – Name: Abstract Label: Group: Ab Data: <i>Copyright of Trials is the property of BioMed Central and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1186/s13063-024-08537-4 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 9 StartPage: 1 Subjects: – SubjectFull: CLUSTER randomized controlled trials Type: general – SubjectFull: WHOLE genome sequencing Type: general – SubjectFull: MYCOBACTERIUM tuberculosis Type: general – SubjectFull: INFECTIOUS disease transmission Type: general – SubjectFull: MOLECULAR epidemiology Type: general – SubjectFull: TUBERCULOSIS Type: general Titles: – TitleFull: 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. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Ametepe, Emmanuelle Sandra Adjoa – PersonEntity: Name: NameFull: Andriamanoha, Noela – PersonEntity: Name: NameFull: Andrianomanana, Fanantenana Randria – PersonEntity: Name: NameFull: Point, Floriane – PersonEntity: Name: NameFull: Mangahasimbola, Reziky Tiandraza – PersonEntity: Name: NameFull: Dyachenko, Alina – PersonEntity: Name: NameFull: Hall, Michael – PersonEntity: Name: NameFull: Gamana, Theodora Mayouya – PersonEntity: Name: NameFull: Knoblauch, Astrid M. – PersonEntity: Name: NameFull: Razafindrasoa, Yemimah Yededyah – PersonEntity: Name: NameFull: Nimalan, Arianminpathy – PersonEntity: Name: NameFull: Behr, Marcel – PersonEntity: Name: NameFull: Durand, Madeleine – PersonEntity: Name: NameFull: Johri, Mira – PersonEntity: Name: NameFull: Iqbal, Zamin – PersonEntity: Name: NameFull: Rakotoarivelo, Andry Rivo – PersonEntity: Name: NameFull: Randremanana, Rindra Vatosoa – PersonEntity: Name: NameFull: Rakotosamimanana, Niaina – PersonEntity: Name: NameFull: Lapierre, Simon Grandjean IsPartOfRelationships: – BibEntity: Dates: – D: 25 M: 10 Text: 10/25/2024 Type: published Y: 2024 Identifiers: – Type: issn-print Value: 17456215 Numbering: – Type: volume Value: 25 – Type: issue Value: 1 Titles: – TitleFull: Trials Type: main |
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