Clinical trial NCT07017803: Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region
Official title: Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Tuberculosis, Multi Drug Resistant
Strains
Molecular Epidemiology
Multi Drug Resistant Tuberculosis
Central Africa
Lead sponsor: Centre de Recherche Médicale de Lambaréné
Sponsor class: OTHER
Collaborators: name: Fondation Congolaise pour la Recherche Médicale
name: Centre Pasteur du Cameroun
name: GlaxoSmithKline
First posted: 2025-06-12
Enrollment: 460
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Samples which do not meet the quality criteria.

  * Samples not enough to perform all of the laboratory process
  * Samples contaminated

Primary outcomes:
measure: Proportion of drug-resistant strains with characterised resistance mutations
timeFrame: 6 months
measure: Proportion of strains with new/undefined mutations among those with unexplained phenotypic resistance
timeFrame: 6 months
measure: Proportion of cases demonstrating transmission links, overall and between countries
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centre de Recherches Medicales de Lambarene
name: Ayôla Akim ADEGNIKA
role: STUDY_DIRECTOR
References: