An interventional study of Whole Genome Sequencing testing in Tuberculosis, sponsored by Institut Pasteur de Madagascar. Completed at 1 site in Madagascar. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by Institut Pasteur de Madagascar · Not applicable, Interventional, and Diagnostic
Tuberculosis (TB) whole genome sequencing (WGS) allows outbreak identification and disease transmission tracking.
It is hypothesized that prospective WGS-guided epidemiological investigations improve case detection compared to current best practices by adapting contact tracing strategies to local transmission patterns.
A cluster randomized controlled trial (cRCT) will be performed in high TB incidence villages of Haute Matsiatra region in Madagascar. Communities will be randomized in three separate TB control strategies comparing (1) standard of care, (2) the World Health Organization (WHO) recommended best practices and (3) a novel intervention involving TB WGS cluster-guided epidemiological investigations. The incremental value of TB WGS on case notifications and reduction of TB burden will be measured.
Secondary studies will be nested within this cRCT will include:
Field and genomic epidemiology data from this project will inform future work on the design of community-level TB elimination strategies in collaboration with Madagascar National TB program
1,435 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 98,362 is above the median of 150 across 963 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Institut Pasteur de Madagascar is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Description : * Passive case finding, * Smear microscopy testing, and * household contact tracing
Description : * Active case finding, * Smear microscopy * Xpert MTB/RIF Ultra testing (= rapid test by Genexpert for tuberculosis (TB) and rifampin resistance (RIF-R)) and * household contact tracing
Description : * Active case finding, * Smear microscopy * Xpert MTB/RIF Ultra testing and * household contact tracing
Other: Whole Genome Sequencing testing
Whole Genome Sequencing testing, community-based contact tracing
the total number of TB cases detected / 100 000 inhabitants
total number of TB cases detected / 100,000 inhabitants / year in each group during the first year of the intervention.
Time frame: an average of 1 year
Plan to share: Yes — Upon request to the investigator
Supporting information: Study protocol, Informed consent form
Time frame: Upon request
Access criteria: Upon request to the investigator
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Institut Pasteur de Madagascar