About this trial
Multidrug-resistant tuberculosis (MDR-TB) poses a significant challenge in Central Africa. Understanding the molecular epidemiology and genotypic characteristics of MDR-TB strains is crucial for effective control measures. This is highlighted by the emergence of mutations encoding resistance to bed aquiline and quinolones which may impact the roll out of the newly recommended Bedaquiline, Pretomanid, Linezolid and Moxifloxacin (BPaLM) regimens.
It is also worth noting that there is increasing evidence of the significance of TB lineage in the outcome of infection, the approach in the study will provide both information on chains of transmission and lineage.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All GeneXpert positive TB patients and participants who provide written informed consent will be screened for the study. Participants aged above 8 who can provide sputum will also be screened.
Patients enrolled in the tuberculosis epidemiology (TB-EPI) study and eligible for MESTCAR will be enrolled without any additional consent form as the data to be collected for the two studies will be shared and no additional process is needed.
Disqualifiers
Samples which do not meet the quality criteria.
Samples not enough to perform all of the laboratory process
Samples contaminated
Trial population
The study population will be all TB presumptive patients who will be diagnosed and willing to participate in the selected facilities in the three countries, the different sites involved in the study are Institut Pasteur de Yaoundé (Cameroon), Centre de Recherche Medicales de Lambaréné (Gabon) and Laboratoire National de Reference de Tuberculose du Congo (Republic of Congo). In Gabon, this study will be included in the ongoing sequencing TB studys. Samples collected for ongoing TB study will be used to avoid competing sample collection. Two or more separate aliquot storage samples will be used for METSCAR and TB-EPI studies. This, together with the fact that the workgroups overlap 100%, will allow the ongoing studies in the group to be performed complementarily.
Trial design
Case-only
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Proportion of drug-resistant strains with characterised resistance mutations
Proportion of strains with new/undefined mutations among those with unexplained phenotypic resistance
Proportion of cases demonstrating transmission links, overall and between countries
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre de Recherche Médicale de Lambaréné
Lead sponsor
Fondation Congolaise pour la Recherche Médicale
Collaborator
Centre Pasteur du Cameroun
Collaborator
GlaxoSmithKline
Collaborator
This trial is not recruiting at the moment. You can still explore other options: