DIAgnostics for Multidrug Resistant Tuberculosis in Africa

Summary

Recent advances in molecular diagnostics of tuberculosis, especially the GeneXpert Mycobacterium tuberculosis/Rifampicin test have reduced the time to diagnose Rifampicin Resistant Tuberculosis (RR-TB) but only rifampicin resistance is diagnosed, leading to presumptive diagnosis of resistance to isoniazid and maybe other drugs. Thus in low and middle income countries, most drug sensitivity testing relies on phenotypic drug resistance testing, which takes up to 4 months. In addition, currently, culture on monthly sputum samples is recommended by the World Health Organization for follow-up of Rifampicin Resistant Tuberculosis patients under treatment. Unfortunately, culture is often not locally available and samples need to be transported from field to culture laboratories. The associated transport delays lead to high rates of contamination and false negative culture, particularly in laboratories in low resource settings. Many gaps for the diagnosis and management of RR-TB patients still need to be addressed and the DIAMA project (DIAgnostics for Multidrug resistant tuberculosis in Africa) study aims to address some of them.

Conditions

• Tuberculosis, Multidrug-Resistant

Interventions

DIAGNOSTIC_TEST

Deeplex test, MolBio TrueNat for 2nd line, GeneXpert 2nd line

Improvement of the diagnosis of Multi Drug Resistant-Tuberculosis patients with culture-free approaches. We have planned to diagnose Tuberculosis resistance to 1st and 2nd line drugs through novel molecular multiplex assays (Study 1) by: * Validating the Deeplex test and establish a network for shipment of sputum samples in ethanol to regional reference laboratories (Study 1 - phase 1) * Validating the Molbio Truenat test as a point of care test (Study 1 - phase 2) * Validating the Cepheid GeneXpert 2nd line cartridge at the district level (Study 1 -phase2)

DIAGNOSTIC_TEST

Fluorescein DiAcetate (FDA) Microscopy,GeneXpert Ct value, pre-rRNA synthesis

Improvement of the management of Multi Drug Resistant-Tuberculosis patients with culture-free approaches. We have planned to set up alternative culture-free approaches for the monitoring of patients' response to Multi Drug Resistant-Tuberculosis treatment (Study 2), with: * FDA microscopy * Measurement of bacterial load by following Cycle threshold (Ct) values in GeneXpert Mycobacterium tuberculosis/Rifampicin * Measurement of pre-rRNA synthesis

Sponsors & Collaborators

• Rwanda Biomedical Centre

  collaborator OTHER

• The Tuberculosis Reference Laboratory Bamenda

  collaborator UNKNOWN

• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

  collaborator OTHER

• Jimma University

  collaborator OTHER

• Service de Pneumophtisiologie, Hôpital Ignace Deen

  collaborator UNKNOWN

• University of the Sciences, Techniques and Technologies of Bamako

  collaborator OTHER

• Damien Foundation

  collaborator OTHER

• Cheikh Anta Diop University, Senegal

  collaborator OTHER

• Institute of Tropical Medicine, Belgium

  collaborator OTHER

• World Health Organization

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Genoscreen

  collaborator OTHER

• Dissou AFFOLABI

  lead OTHER_GOV

Principal Investigators

• Dissou AFFOLABI, MD, MSc, PhD · Laboratoire de Référence des Mycobactéries

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-04

Primary Completion

2022-06-30

Completion

2022-11-30

Countries

• Belgium
• Benin
• Cameroon
• Democratic Republic of the Congo
• Ethiopia
• Guinea
• Mali
• Nigeria
• Rwanda
• Senegal

Study Locations