Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region

NCT07017803 | Not Yet Recruiting

• 1 other identifier: CEI-004/2025
• Study Type: observational
• Target: 460
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tuberculosis, Multi Drug Resistant; Strains; Molecular Epidemiology; Multi Drug Resistant Tuberculosis; Central Africa

Outcome Measures

Primary Outcomes (3)

• Proportion of drug-resistant strains with characterised resistance mutations

  6 months

• Proportion of strains with new/undefined mutations among those with unexplained phenotypic resistance

  6 months

• Proportion of cases demonstrating transmission links, overall and between countries

  6 months

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Samples which do not meet the quality criteria.
• Samples not enough to perform all of the laboratory process
• Samples contaminated

Sponsors & Collaborators

• Centre de Recherche Médicale de Lambaréné: lead
• Fondation Congolaise pour la Recherche Médicale: collaborator
• Centre Pasteur du Cameroun: collaborator
• GlaxoSmithKline: collaborator

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant; Sprains and Strains

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Wounds and Injuries

Study Officials

• Ayôla Akim ADEGNIKA

  Centre de Recherches Medicales de Lambarene

  STUDY DIRECTOR

Central Study Contacts

Jabar Babatunde Pacome AGBO ACHIMI ABDUL

CONTACT

+24177469843; pacomeabdul@gmail.com

Rick elsy mirna NNOH DANSOU AKOUA

CONTACT

+241 74474314; elsydansou@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: July 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: January 31, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06