Multidrug-resistant Tuberculosis (MDR-TB)MESTCARNCT07017803
Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region
An observational study of Multidrug-resistant Tuberculosis (MDR-TB), run by Centre de Recherche Médicale de Lambaréné at 8 sites in Gabon.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multidrug-resistant Tuberculosis (MDR-TB)
- How many people
- 460 participants
- Where
- 8 sitesGabon
- Study dates
- 9 Feb 2026to 24 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Samples which do not meet the quality criteria.
- Samples not enough to perform all of the laboratory process
- Samples contaminated
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
Gabon8 sites, 8 recruiting
- Recruiting
Centre Hospitalier Régional Georges Rawiri
Lambaréné
- Recruiting
Hôpital Albert Schweitzer
Lambaréné
- Recruiting
Hôpital de Nkembo
Libreville
- Recruiting
Centre Hospitalier Régional de Makokou
Makokou
- Recruiting
Centre de Traitement Ambulatoire (CTA) de Mouila
Mouila
- Recruiting
Hôpital de Bongolo
Mouila
- Recruiting
Centre Hospitalier Régional d'Oyem
Oyem
- Recruiting
Centre Hospitalier Régional Tchégué
Port-Gentil
About this study
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.
- Medical subject headings
- Tuberculosis, Multidrug-Resistant
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of drug-resistant strains with characterised resistance mutations
Measured: 6 months
Proportion of strains with new/undefined mutations among those with unexplained phenotypic resistance
Measured: 6 months
Proportion of cases demonstrating transmission links, overall and between countries
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start9 Feb 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion24 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multidrug-resistant Tuberculosis (MDR-TB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche Médicale de Lambaréné
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Congolaise pour la Recherche Médicale, GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Ayôla Akim ADEGNIKA, Study director, Centre de Recherches Medicales de Lambarene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017803
- Sponsor's protocol ID
- CEI-004/2025
- Acronym
- MESTCAR
- Status last verified
- Oct 2026
- First submitted
- 4 Jun 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region
- ClinicalTrials.gov ID
- NCT07017803
- Acronym / sponsor ID
- MESTCAR / CEI-004/2025
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Centre de Recherche Médicale de LambarénéUniversity, hospital or other
- Collaborators
- Fondation Congolaise pour la Recherche Médicale, GlaxoSmithKline
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 24 Dec 2026 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Samples which do not meet the quality criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of drug-resistant strains with characterised resistance mutations
Time frame: 6 months
Proportion of strains with new/undefined mutations among those with unexplained phenotypic resistance
Time frame: 6 months
Proportion of cases demonstrating transmission links, overall and between countries
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayôla Akim ADEGNIKA study director
Centre de Recherches Medicales de Lambarene
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multidrug-resistant Tuberculosis (MDR-TB), run by Centre de Recherche Médicale de Lambaréné at 8 sites in Gabon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Gabon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jabar Babatunde Pacome AGBO ACHIMI ABDUL (+24177469843, pacomeabdul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of drug-resistant strains with characterised resistance mutations (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.