Benin Population Diversity of Tuberculosis and Implications
NCT ID: NCT02744469
Last Updated: 2021-02-23
Study Results
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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COMPLETED
1490 participants
OBSERVATIONAL
2016-04-12
2019-12-12
Brief Summary
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Detailed Description
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This study will build on the system of nationwide surveillance already implemented for retreatment patients and recruit in addition a representative random sample of new patients. So for this study sputa from retreatment patients and from a sample of new patients, from the 24 tuberculosis (TB) clinics (Centres de Diagnostic et de Traitement de la Tuberculose) selected all over the country (Benin), will be shipped from TB clinics to the ''Laboratoire de Référence des Mycobactéries'' (LRM), Cotonou (National Reference Laboratory for Mycobacteria, Cotonou) if they consent. All retreatment patients will be recruited into the study and each 4 new patients detected after detection of a retreatment patient will also be recruited into the study.
At enrolment, a questionnaire will be used to collect from consenting participants information such as: Participant place of residence (rural or urban as determined by population density); ethnic group; age; sex; Human Immuno-deficiency Virus (HIV) status; Bacillus Calmette Guerin (BCG) vaccine scar...
Spoligotype analysis will be used to determine the population structure, as it allows the classification of most Mycobacterium tuberculosis complex isolates in lineages, including strains with single or few copies of IS6110.
The external quality evaluation (assurance quality) of the laboratory analyses to be performed at the LRM (National Reference Laboratory for Mycobacteria) in Cotonou, Benin during the study, will be performed by the Institute of Tropical Medicine of Antwerp in Belgium.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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New patients
''New tuberculosis patients'' are patients just diagnosed for tuberculosis, and who were never treated for tuberculosis or who are treated for less than 1 month. In total, 1192 new patients will be recruited.
No intervention (observational study)
Retreatment patients
''Retreatment tuberculosis patients'' are patients just diagnosed for tuberculosis and who were previously treated for tuberculosis (for a duration of 1 month at least). This group includes: patients with treatment relapse, failure and patients who return after default. In total, 298 retreatment patients will be recruited.
No intervention (observational study)
Interventions
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No intervention (observational study)
Eligibility Criteria
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Inclusion Criteria
* Diagnosed in a participating TB clinic of Benin,
* Aged ≥15 years (Patients aged less than 15 years old will not be included in this study as acid-fast-bacilli microscopy is rarely positive in children)
* Who has given his/her informed consent (if adult potential participant:≥18 years old) OR who has given his/her assent in addition to the informed consent of his/her legal representative (if potential participant aged 15-\<18 years)
Exclusion Criteria
* New patient who has started taking the TB treatment drugs.
* Retreatment patient who has started taking the TB retreatment drugs.
* Very low sputum quantity (at least 5 milliliters total sputum is acceptable) and potential participant refusing to give more sputum
15 Years
ALL
No
Sponsors
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Direction Générale de la Coopération au Développement, Belgique
UNKNOWN
Institute of Tropical Medicine, Belgium
OTHER
Universiteit Antwerpen
OTHER
Laboratoire de Référence des Mycobactéries, Benin republic
UNKNOWN
Centre National Hospitalier Universitaire de Pneumo-Phtisiologie de Cotonou, Benin
UNKNOWN
Centres de Diagnostic et de Traitement de la tuberculose, National Tuberculosis Programme, Benin
UNKNOWN
Laboratoire de Référence des Mycobactéries
OTHER_GOV
Responsible Party
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Principal Investigators
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Dissou Affolabi, MD PhD Prof
Role: PRINCIPAL_INVESTIGATOR
Laboratoire de Référence des Mycobactéries, Benin
Bouke de Jong, MD PhD Prof
Role: PRINCIPAL_INVESTIGATOR
Institute of Tropical Medicine, Belgium
Locations
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Institute of Tropical Medicine
Antwerp, , Belgium
Centre de Diagnostic et de Traitement de la Tuberculose de Djougou
Djougou, Atacora/Donga, Benin
Centre de Diagnostic et de Traitement de la Tuberculose de Matéri
Matéri, Atacora/Donga, Benin
Centre de Diagnostic et de Traitement de la Tuberculose de Natitingou
Natitingou, Atacora/Donga, Benin
Centre de Diagnostic et de Traitement de la Tuberculose de Tanguiéta
Tanguiéta, Atacora/Donga, Benin
Centre de Diagnostic et de Traitement de la tuberculose d'Abomey-Calavi
Abomey-Calavi, Atlantique/Littoral, Benin
Centre de Diagnostic et de Traitement de la Tuberculose d'Allada
Allada, Atlantique/Littoral, Benin
Centre National Hospitalier Universitaire de Pneumo-Phtisiologie de Cotonou
Cotonou, Atlantique/Littoral, Benin
Centre de Diagnostic et de Traitement de la Tuberculose de Ouidah
Ouidah, Atlantique/Littoral, Benin
Centre de Diagnostic et de Traitement de la Tuberculose de Bembèrèkè HE
Bembèrèkè, Borgou/Alibori, Benin
Centre de Diagnostic et de Traitement de la Tuberculose de Kandi
Kandi, Borgou/Alibori, Benin
Centre de Diagnostic et de Traitement de la Tuberculose de Nikki Hopital Sounou-Séro
Nikki, Borgou/Alibori, Benin
Centre de Diagnostic et de Traitement de la Tuberculose de Parakou CSCom
Parakou, Borgou/Alibori, Benin
Laboratoire de Référence des Mycobactéries
Cotonou, Littoral Department, Benin
Centre de Diagnostic et de Traitement de la Tuberculose d'Aplahoué
Aplahoué, Mono/Couffo, Benin
Centre de Diagnostic et de Traitement de la Tuberculose de Bopa
Bopa, Mono/Couffo, Benin
Centre de Diagnostic et de Traitement de la Tuberculose de Comè
Comè, Mono/Couffo, Benin
Centre de Diagnostic et de Traitement de la Tuberculose de Houéyogbé
Péda-Houéyogbé, Mono/Couffo, Benin
Centre de Diagnostic et de Traitement de la Tuberculose de Avrankou
Avrankou, Oueme/Plateau, Benin
Centre de Diagnostic et de Traitement de la Tuberculose de Pobè
Pobé, Oueme/Plateau, Benin
Centre de Pneumo-Phtisiologie d'Akron
Porto-Novo, Oueme/Plateau, Benin
Centre de Diagnostic et de Traitement de la Tuberculose de Sakété
Sakété, Oueme/Plateau, Benin
Centre de Diagnostic et de Traitement de la Tuberculose d'Abomey
Abomey, Zou/Collines, Benin
Centre de Diagnostic et de Traitement de la Tuberculose de Bohicon
Bohicon, Zou/Collines, Benin
Centre de Diagnostic et de Traitement de la Tuberculose de Dassa-Zoumè
Dassa-Zoumè, Zou/Collines, Benin
Centre de Diagnostic et de Traitement de la Tuberculose de Zagnanado
Zagnanado, Zou/Collines, Benin
Countries
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References
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Affolabi D, Anyo G, Faihun F, Sanoussi N, Shamputa IC, Rigouts L, Kestens L, Anagonou S, Portaels F. First molecular epidemiological study of tuberculosis in Benin. Int J Tuberc Lung Dis. 2009 Mar;13(3):317-22.
Brudey K, Driscoll JR, Rigouts L, Prodinger WM, Gori A, Al-Hajoj SA, Allix C, Aristimuno L, Arora J, Baumanis V, Binder L, Cafrune P, Cataldi A, Cheong S, Diel R, Ellermeier C, Evans JT, Fauville-Dufaux M, Ferdinand S, Garcia de Viedma D, Garzelli C, Gazzola L, Gomes HM, Guttierez MC, Hawkey PM, van Helden PD, Kadival GV, Kreiswirth BN, Kremer K, Kubin M, Kulkarni SP, Liens B, Lillebaek T, Ho ML, Martin C, Martin C, Mokrousov I, Narvskaia O, Ngeow YF, Naumann L, Niemann S, Parwati I, Rahim Z, Rasolofo-Razanamparany V, Rasolonavalona T, Rossetti ML, Rusch-Gerdes S, Sajduda A, Samper S, Shemyakin IG, Singh UB, Somoskovi A, Skuce RA, van Soolingen D, Streicher EM, Suffys PN, Tortoli E, Tracevska T, Vincent V, Victor TC, Warren RM, Yap SF, Zaman K, Portaels F, Rastogi N, Sola C. Mycobacterium tuberculosis complex genetic diversity: mining the fourth international spoligotyping database (SpolDB4) for classification, population genetics and epidemiology. BMC Microbiol. 2006 Mar 6;6:23. doi: 10.1186/1471-2180-6-23.
de Jong BC, Antonio M, Gagneux S. Mycobacterium africanum--review of an important cause of human tuberculosis in West Africa. PLoS Negl Trop Dis. 2010 Sep 28;4(9):e744. doi: 10.1371/journal.pntd.0000744.
de Jong BC, Hill PC, Aiken A, Awine T, Antonio M, Adetifa IM, Jackson-Sillah DJ, Fox A, Deriemer K, Gagneux S, Borgdorff MW, McAdam KP, Corrah T, Small PM, Adegbola RA. Progression to active tuberculosis, but not transmission, varies by Mycobacterium tuberculosis lineage in The Gambia. J Infect Dis. 2008 Oct 1;198(7):1037-43. doi: 10.1086/591504.
de Jong BC, Hill PC, Brookes RH, Otu JK, Peterson KL, Small PM, Adegbola RA. Mycobacterium africanum: a new opportunistic pathogen in HIV infection? AIDS. 2005 Oct 14;19(15):1714-5. doi: 10.1097/01.aids.0000185991.54595.41. No abstract available.
Gehre F, Antonio M, Faihun F, Odoun M, Uwizeye C, de Rijk P, de Jong BC, Affolabi D. The first phylogeographic population structure and analysis of transmission dynamics of M. africanum West African 1--combining molecular data from Benin, Nigeria and Sierra Leone. PLoS One. 2013 Oct 15;8(10):e77000. doi: 10.1371/journal.pone.0077000. eCollection 2013.
Affolabi D, Faihun F, Sanoussi N, Anyo G, Shamputa IC, Rigouts L, Kestens L, Anagonou S, Portaels F. Possible outbreak of streptomycin-resistant Mycobacterium tuberculosis Beijing in Benin. Emerg Infect Dis. 2009 Jul;15(7):1123-5. doi: 10.3201/eid1507.080697.
Kamerbeek J, Schouls L, Kolk A, van Agterveld M, van Soolingen D, Kuijper S, Bunschoten A, Molhuizen H, Shaw R, Goyal M, van Embden J. Simultaneous detection and strain differentiation of Mycobacterium tuberculosis for diagnosis and epidemiology. J Clin Microbiol. 1997 Apr;35(4):907-14. doi: 10.1128/jcm.35.4.907-914.1997.
Gagneux S, Small PM. Global phylogeography of Mycobacterium tuberculosis and implications for tuberculosis product development. Lancet Infect Dis. 2007 May;7(5):328-37. doi: 10.1016/S1473-3099(07)70108-1.
Castets M. [Mycobacterium africanum (author's transl)]. Med Trop (Mars). 1979 Mar-Apr;39(2):145-8. French.
Parwati I, van Crevel R, van Soolingen D, van der Zanden A. Application of spoligotyping to noncultured Mycobacterium tuberculosis bacteria requires an optimized approach. J Clin Microbiol. 2003 Nov;41(11):5350-1. doi: 10.1128/JCM.41.11.5350-5351.2003. No abstract available.
Asante-Poku A, Yeboah-Manu D, Otchere ID, Aboagye SY, Stucki D, Hattendorf J, Borrell S, Feldmann J, Danso E, Gagneux S. Mycobacterium africanum is associated with patient ethnicity in Ghana. PLoS Negl Trop Dis. 2015 Jan 8;9(1):e3370. doi: 10.1371/journal.pntd.0003370. eCollection 2015 Jan.
Yin X, Zheng L, Lin L, Hu Y, Zheng F, Hu Y, Wang Q. Commercial MPT64-based tests for rapid identification of Mycobacterium tuberculosis complex: a meta-analysis. J Infect. 2013 Nov;67(5):369-77. doi: 10.1016/j.jinf.2013.06.009. Epub 2013 Jun 22.
Sanoussi CN, de Jong BC, Affolabi D, Meehan CJ, Odoun M, Rigouts L. Storage of Sputum in Cetylpyridinium Chloride, OMNIgene.SPUTUM, and Ethanol Is Compatible with Molecular Tuberculosis Diagnostic Testing. J Clin Microbiol. 2019 Jun 25;57(7):e00275-19. doi: 10.1128/JCM.00275-19. Print 2019 Jul.
Sanoussi CN, Affolabi D, Rigouts L, Anagonou S, de Jong B. Genotypic characterization directly applied to sputum improves the detection of Mycobacterium africanum West African 1, under-represented in positive cultures. PLoS Negl Trop Dis. 2017 Sep 1;11(9):e0005900. doi: 10.1371/journal.pntd.0005900. eCollection 2017 Sep.
Other Identifiers
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CNERS N°030 of 15th/12/2015
Identifier Type: OTHER
Identifier Source: secondary_id
ITM- N°1040/15
Identifier Type: OTHER
Identifier Source: secondary_id
EC UZA 15/49/532
Identifier Type: OTHER
Identifier Source: secondary_id
Belg registN°:B300201526865
Identifier Type: OTHER
Identifier Source: secondary_id
LRM-N°030-15/12/2015
Identifier Type: -
Identifier Source: org_study_id
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