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

NCT ID: NCT07017803

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

460 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondation Congolaise pour la Recherche Médicale

UNKNOWN

Sponsor Role collaborator

Centre Pasteur du Cameroun

OTHER

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Centre de Recherche Médicale de Lambaréné

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ayôla Akim ADEGNIKA

Role: STUDY_DIRECTOR

Centre de Recherches Medicales de Lambarene

Central Contacts

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Jabar Babatunde Pacome AGBO ACHIMI ABDUL

Role: CONTACT

+24177469843

Rick elsy mirna NNOH DANSOU AKOUA

Role: CONTACT

+241 74474314

Other Identifiers

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CEI-004/2025

Identifier Type: -

Identifier Source: org_study_id

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