Culture free diagnosis and follow-up of multidrug resistant tuberculosis patients (DIAMA)

Principal investigator: Ngabonziza S Jean Claude
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Investigators

Dissou Affolabi, Jean Claude Semuto Ngabonziza, Jean Baptiste Mazarati, Patrick Migambi , Emil Ivan Mwikarago, Yves Mucyo Habimana, Melissa
Sander, Michel Kaswa, Gemeda Abebe, Oumou Sow, Bassirou Diarra, Osman Eltayeb, Aissatou Gaye-Diallo, Bouke de Jong, Corinne Merle, Sian
Floyd, Philip Supply

Study information

  • Research Area: Tuberculosis
  • Research type: Two multi center observational studies will be conducted. Study 1-Cross sectional study; 2- Cohort study of RR-TB patients (recruited in Study 1)
  • Start date: Feb 11, 2016
  • End date: Mar 11, 2021

Study aim of the objectives

Overall Aim:
-To improve diagnosis and management of MDR-TB patients with culture-free approaches

Primary objectives:
1. To diagnose TB resistance to 1st and 2nd line drugs through novel molecular multiplex assays (Study 1)
a. To validate the Deeplex assay and establish a network for shipment of sputum samples in ethanol to regional reference laboratories
b. To validate the Molbio Truenat test as a point of care test (Study 1 – phase 2)
c. To validate the Cepheid Xpert 2nd line cartridge at the district level (Study 1 – phase
2. To setup alternative culture-free approaches for the monitoring of patients’ response to MDR treatment (Study 2), with:
a. FDA microscopy
b. Measurement of bacterial load by following Cycle threshold (Ct) values in Xpert MTB/Rif
c. Measurement of pre-rRNA synthesis
3. To assess the prevalence of mutations associated with rifampicin resistance outside the RRDR and of ‘disputed’ mutations in the rpoB gene
among previously treated TB patients in Rwanda.

Secondary objectives:
1. To estimate the proportion of additional resistance in patients resistant to RIF (isoniazid, and other drugs) in the countries involved using the
novel validated tests and identify associations of programmatic outcome in MDR patients.
2. To measure the association of specific mutations against INH and PZA with programmatic treatment outcome
3. To pilot whether implementation of DataToCare for real-time monitoring of molecular
test results can reduce delay between diagnosis and treatment of RR-TB patients

Study setting/Area (Location)

Benin, Cameroon, DRC, Ethiopia, Guinea, Mali, Nigeria, Rwanda and Senegal

Implementing institution

Jimma University, RBC, Université des Sciences, des Techniques et des Technologies de Bamako, Université Cheikh Anta Diop Senegal, World Health Organization et al

Department/Division

TB &ORD and NRL

Impact on Policy

The advances in this study are expected to dramatically improve the currently dismal prognosis of MDR-TB in health systems in resource-poor settings and to inform treatment guidelines and policies

Study implementation progress

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