Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-28 @ 6:15 AM
Study NCT ID:
NCT07017803
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018088', 'term': 'Tuberculosis, Multidrug-Resistant'}, {'id': 'D013180', 'term': 'Sprains and Strains'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 460}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2025-06-04', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Tuberculosis, Multi Drug Resistant', 'Strains', 'Molecular Epidemiology', 'Multi Drug Resistant Tuberculosis', 'Central Africa']}, 'descriptionModule': {'briefSummary': '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.\n\nIt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '9 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Samples which do not meet the quality criteria.\n\n * Samples not enough to perform all of the laboratory process\n * Samples contaminated'}, 'identificationModule': {'nctId': 'NCT07017803', 'acronym': 'MESTCAR', 'briefTitle': 'Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region', 'organization': {'class': 'OTHER', 'fullName': 'Centre de Recherche Médicale de Lambaréné'}, 'officialTitle': 'Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region', 'orgStudyIdInfo': {'id': 'CEI-004/2025'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jabar Babatunde Pacome AGBO ACHIMI ABDUL', 'role': 'CONTACT', 'email': 'pacomeabdul@gmail.com', 'phone': '+24177469843'}, {'name': 'Rick elsy mirna NNOH DANSOU AKOUA', 'role': 'CONTACT', 'email': 'elsydansou@gmail.com', 'phone': '+241 74474314'}], 'overallOfficials': [{'name': 'Ayôla Akim ADEGNIKA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre de Recherches Medicales de Lambarene'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre de Recherche Médicale de Lambaréné', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation Congolaise pour la Recherche Médicale', 'class': 'UNKNOWN'}, {'name': 'Centre Pasteur du Cameroun', 'class': 'OTHER'}, {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}