DIAgnostics for Multidrug Resistant Tuberculosis in Africa

CompletedOBSERVATIONAL
Enrollment

3,356

Participants

Timeline

Start Date

May 4, 2017

Primary Completion Date

June 30, 2022

Study Completion Date

November 30, 2022

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"

Trial Locations (10)

Unknown

Institute of Tropical Medecine, Antwerp

The Tuberculosis Reference Laboratory Bamenda, Bamenda

Institut National de Recherche Biomédicale (INRB), Kinshasa

Jimma University, Jīma

Service de Pneumophtisiologie, Hôpital Ignace Deen, Conakry, Conakry

Université des Sciences, des Techniques et des Technologies de Bamako, SEREFO, Bamako

Damien Fundation, Ibadan

Rwanda Biomedical Center (RBC), Kigali

Université Cheick Anta Diop (UCAD), Dakar

01BP321

Centre National Hospitalier Universitaire de Pneumo-Phtisiologie de Cotonou, Cotonou

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Rwanda Biomedical Centre

OTHER

collaborator

The Tuberculosis Reference Laboratory Bamenda

UNKNOWN

collaborator

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

OTHER

collaborator

Jimma University

OTHER

collaborator

Service de Pneumophtisiologie, Hôpital Ignace Deen

UNKNOWN

collaborator

University of the Sciences, Techniques and Technologies of Bamako

OTHER

collaborator

Damien Foundation

OTHER

collaborator

Cheikh Anta Diop University, Senegal

OTHER

collaborator

Institute of Tropical Medicine, Belgium

OTHER

collaborator

World Health Organization

OTHER

collaborator

London School of Hygiene and Tropical Medicine

OTHER

collaborator

Genoscreen

OTHER

lead

Dissou AFFOLABI

OTHER_GOV