TuberculosisBeniDiTNCT02744469
Benin Population Diversity of Tuberculosis and Implications
An observational study of Tuberculosis, run by Laboratoire de Référence des Mycobactéries at 26 sites in 2 countries.
Trial summary
Tuberculosis is a public health problem caused by a microbe. This microbe may differ from one patient to another. The purpose of this study is to know to which extent, each of these various microbes is involved in tuberculosis disease in Benin. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Tuberculosis
- How many people
- 1,490 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 12 Apr 2016to 12 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: There is a National Tuberculosis Program in Benin with a network of 57 TB (tuberculosis) 'diagnosis and treatment centers' (TB clinics). In order to be able to ensure a realistic (cost, time, personnel) strong quality control of data to record on fields in TB clinics, a smaller number of TB clinics where most of Benin TB patients are diagnosed is selected instead of including all the 57 TB clinics. Participants will be recruited from the 4 largest TB clinics of each of Benin's 6 (former) departments (Atlantique/Littoral, Oueme/Plateau, Mono/Couffo, Zou/Collines, Borgou/Alibori, Atacora/Donga), amounting to 24 TB clinics.
Who may be able to join
- New or retreatment tuberculosis patients with Acid Fast Bacilli-positive microscopy,
- 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)
Who cannot join
- Extra-pulmonary TB only,
- 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
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
Benin25 sites
Centre de Diagnostic et de Traitement de la Tuberculose d'Abomey
Abomey, Zou/Collines
Centre de Diagnostic et de Traitement de la tuberculose d'Abomey-Calavi
Abomey-Calavi, Atlantique/Littoral
Centre de Diagnostic et de Traitement de la Tuberculose d'Allada
Allada, Atlantique/Littoral
Centre de Diagnostic et de Traitement de la Tuberculose d'Aplahoué
Aplahoue, Mono/Couffo
Centre de Diagnostic et de Traitement de la Tuberculose de Avrankou
Avrankou, Oueme/Plateau
Centre de Diagnostic et de Traitement de la Tuberculose de Bembèrèkè HE
Bembèrèkè, Borgou/Alibori
Centre de Diagnostic et de Traitement de la Tuberculose de Bohicon
Bohicon, Zou/Collines
Centre de Diagnostic et de Traitement de la Tuberculose de Bopa
Bopa, Mono/Couffo
Centre de Diagnostic et de Traitement de la Tuberculose de Comè
Comè, Mono/Couffo
Centre National Hospitalier Universitaire de Pneumo-Phtisiologie de Cotonou
Cotonou, Atlantique/Littoral, 01BP321
Laboratoire de Référence des Mycobactéries
Cotonou, Littoral Department, 01BP321
Centre de Diagnostic et de Traitement de la Tuberculose de Dassa-Zoumè
Dassa-Zoume, Zou/Collines
Centre de Diagnostic et de Traitement de la Tuberculose de Djougou
Djougou, Atacora/Donga
Centre de Diagnostic et de Traitement de la Tuberculose de Kandi
Kandi, Borgou/Alibori
Centre de Diagnostic et de Traitement de la Tuberculose de Matéri
Matéri, Atacora/Donga
Centre de Diagnostic et de Traitement de la Tuberculose de Natitingou
Natitingou, Atacora/Donga
Centre de Diagnostic et de Traitement de la Tuberculose de Nikki Hopital Sounou-Séro
Nikki, Borgou/Alibori
Centre de Diagnostic et de Traitement de la Tuberculose de Ouidah
Ouidah, Atlantique/Littoral
Centre de Diagnostic et de Traitement de la Tuberculose de Parakou CSCom
Parakou, Borgou/Alibori
Centre de Diagnostic et de Traitement de la Tuberculose de Houéyogbé
Péda-Houéyogbé, Mono/Couffo
Centre de Diagnostic et de Traitement de la Tuberculose de Pobè
Pobé, Oueme/Plateau
Centre de Pneumo-Phtisiologie d'Akron
Porto-Novo, Oueme/Plateau
Centre de Diagnostic et de Traitement de la Tuberculose de Sakété
Sakété, Oueme/Plateau
Centre de Diagnostic et de Traitement de la Tuberculose de Tanguiéta
Tanguiéta, Atacora/Donga
Centre de Diagnostic et de Traitement de la Tuberculose de Zagnanado
Zagnanado, Zou/Collines
About this study
Official title: Implications of the Population Structure of the Mycobacterium Tuberculosis Complex in Benin for Tuberculosis Presentation, Diagnosis and Outcome
Tuberculosis is a public health problem caused by a microbe. This microbe may differ from one patient to another. The purpose of this study is to know to which extent, each of these various microbes is involved in tuberculosis disease in Benin. This study will also find out whether the type that affects a patient, depends on patient characteristics and whether the difference affects the outcome of the treatment. Finally the study will also help to find out whether diagnostic tests are reliable for all types of the microbe. This information will be used after the study to inform decision making in order to improve tuberculosis control.
Read the detailed description
The overall aim of this study is to determine the population structure of Mycobacterium tuberculosis complex in Benin, and implications for tuberculosis presentation, diagnosis and outcome The primary objective is to compare the characteristics of ancestral lineages of Mycobacterium tuberculosis complex, such as M. africanum West African 1 (Lineage 5), with modern M. tuberculosis in Benin.
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
- Tuberculosis
- Being tested
- No intervention (observational study)
- Keywords
- Tuberculosis, population structure, implications, lineages, spoligotyping, sputum, resistance, culture, diagnostics, outcome, new/retreatment patient
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 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. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lineage
Mycobacterium tuberculosis lineage as determined by the spoligotyping pattern. The lineage will be determined using the specimen collected at participant enrolment. Spoligotyping will be done on sputum, or on culture isolate if failed on sputum and culture is positive.
Measured: At enrollment
Secondary outcomes (10)
Spoligotype (family)
Mycobacterium tuberculosis spoligotype (family) as determined by the spoligotyping pattern. The lineage will be determined using the specimen collected at participant enrolment.
Measured: At enrollment
Treatment failure or success as evidenced by microscopy result (for new and retreatment patients)
Treatment failure will be ascertained at the end of the treatment period using microscopy for detection of acid-fast bacilli in participant' sputa. Treatment failure or success will be measured using microscopy, only for new and retreatment patients.
Measured: At Month 6 for new patient; at Month 8 for retreatment patients
Treatment failure or success as evidenced by culture result (for rifampicin resistant patients)
Treatment failure will be ascertained at the end of the 20 months treatment period by culturing sputa from rifampicin resistant participants.
Measured: At Month 20 for rifampicin resistant patients
Relapse ascertainment (by questioning and retrospective check of microscopy evidence in TB clinics)
Participants will be called and will be asked whether they have experienced another episode of tuberculosis. This will be retrospectively confirmed in the TB clinic by checking microscopy results for the new episode of tuberculosis.
Measured: At Month 18 for new patients; at Month 20 for retreatment patients; at Month 32 for rifampicin resistant patients
Chest X-ray findings
Chest X-ray will be performed in participants to be enrolled in Cotonou and Porto-Novo, the 2 biggest TB clinics and where X-ray is available.
Measured: At enrollment
Culture positivity
Isolation of mycobacteria (in vitro mycobacterial growth) in culture
Measured: At enrollment
Phenotypic Drug-resistance or susceptibility
Drug resistance as determined using phenotypic drug susceptibility testing on 1st and 2nd line anti-tuberculous drugs
Measured: At enrollment (if positive culture)
Genotypic resistance to rifampin (GeneXpert)
Resistance of Mycobacterium tuberculosis to rifampin as determined using the GeneXpert Mtb/Rif test.
Measured: At enrollment
(Phenotypic)Type of Mycobacteria (tuberculous or non-tuberculous)
Group of Mycobacteria (tuberculous or non-tuberculous) as determined by the result of phenotypic drug sensitivity testing on para-nitro-benzoic acid
Measured: At enrollment (if positive culture)
(Mpt64's)Type of Mycobacteria (tuberculous or non-tuberculous)
Group of Mycobacteria (tuberculous or non-tuberculous) as determined using the Mpt64 antigen test
Measured: At enrollment (if positive culture)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study start12 Apr 2016
- Primary completion8 Jan 2018
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire de Référence des Mycobactéries
- Sponsor type
- Other government
- Collaborators
- Direction Générale de la Coopération au Développement, Belgique, Institute of Tropical Medicine, Belgium, Universiteit Antwerpen, Laboratoire de Référence des Mycobactéries, Benin republic, Centre National Hospitalier Universitaire de Pneumo-Phtisiologie de Cotonou, Benin, Centres de Diagnostic et de Traitement de la tuberculose, National Tuberculosis Programme, Benin
- Responsible party
- Sponsor
- Investigators
- Dissou Affolabi, MD PhD Prof, Principal investigator, Laboratoire de Référence des Mycobactéries, BeninBouke de Jong, MD PhD Prof, Principal investigator, Institute of Tropical Medicine, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744469
- Sponsor's protocol ID
- LRM-N°030-15/12/2015
- Other IDs
- CNERS N°030 of 15th/12/2015, ITM- N°1040/15, EC UZA 15/49/532, Belg registN°:B300201526865
- Acronym
- BeniDiT
- Status last verified
- Feb 2021
- First submitted
- 4 Apr 2016
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19275790Brudey 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.
PubMed 16519816de 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.
PubMed 20927191de 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.
PubMed 18702608de 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.
PubMed 16184053Gehre 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.
PubMed 24143198Affolabi 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.
PubMed 19624936Kamerbeek 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.
PubMed 9157152Gagneux 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.
PubMed 17448936Castets M. [Mycobacterium africanum (author's transl)]. Med Trop (Mars). 1979 Mar-Apr;39(2):145-8. French.
PubMed 91078Parwati 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.
PubMed 14605204Asante-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.
PubMed 25569290Yin 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.
PubMed 23796870Sanoussi 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.
PubMed 31092592Sanoussi 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.
PubMed 28863143
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications of the Population Structure of the Mycobacterium Tuberculosis Complex in Benin for Tuberculosis Presentation, Diagnosis and Outcome
- ClinicalTrials.gov ID
- NCT02744469
- Acronym / sponsor ID
- BeniDiT / LRM-N°030-15/12/2015
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, population structure, implications, lineages, spoligotyping, sputum, resistance, culture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,490 participants (actual)
- Lead sponsor
- Laboratoire de Référence des MycobactériesOther government
- Collaborators
- Direction Générale de la Coopération au Développement, Belgique, Institute of Tropical Medicine, Belgium, Universiteit Antwerpen, Laboratoire de Référence des Mycobactéries, Benin republic, Centre National Hospitalier Universitaire de Pneumo-Phtisiologie de Cotonou, Benin, Centres de Diagnostic et de Traitement de la tuberculose, National Tuberculosis Programme, Benin
- Study start
- 12 Apr 2016 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 20 Apr 2016 (estimated)
- 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.
Tuberculosis is a public health problem caused by a microbe. This microbe may differ from one patient to another. The purpose of this study is to know to which extent, each of these various microbes is involved in tuberculosis disease in Benin. This study will also find out whether the type that affects a patient, depends on patient characteristics and whether the difference affects the outcome of the treatment. Finally the study will also help to find out whether diagnostic tests are reliable for all types of the microbe. This information will be used after the study to inform decision making in order to improve tuberculosis control.
Detailed description
The overall aim of this study is to determine the population structure of Mycobacterium tuberculosis complex in Benin, and implications for tuberculosis presentation, diagnosis and outcome The primary objective is to compare the characteristics of ancestral lineages of Mycobacterium tuberculosis complex, such as M. africanum West African 1 (Lineage 5), with modern M. tuberculosis in Benin.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New patients | – | Other: No intervention (observational study)''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. |
| Retreatment patients | – | Other: No intervention (observational study)''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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- There is a National Tuberculosis Program in Benin with a network of 57 TB (tuberculosis) 'diagnosis and treatment centers' (TB clinics). In order to be able to ensure a realistic (cost, time, personnel) strong quality control of data to record on fields in TB clinics, a smaller number of TB clinics where most of Benin TB patients are diagnosed is selected instead of including all the 57 TB clinics. Participants will be recruited from the 4 largest TB clinics of each of Benin's 6 (former) departments (Atlantique/Littoral, Oueme/Plateau, Mono/Couffo, Zou/Collines, Borgou/Alibori, Atacora/Donga), amounting to 24 TB clinics.
Key inclusion criteria (4 listed)
- New or retreatment tuberculosis patients with Acid Fast Bacilli-positive microscopy,
- 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)
Key exclusion criteria (4 listed)
- Extra-pulmonary TB only,
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (observational study) | Other | New patients, Retreatment patients |
Primary outcome
Lineage
Time frame: At enrollment
Mycobacterium tuberculosis lineage as determined by the spoligotyping pattern. The lineage will be determined using the specimen collected at participant enrolment. Spoligotyping will be done on sputum, or on culture isolate if failed on sputum and culture is positive.
10 secondary outcomes
Spoligotype (family)
Time frame: At enrollment
Treatment failure or success as evidenced by microscopy result (for new and retreatment patients)
Time frame: At Month 6 for new patient; at Month 8 for retreatment patients
Treatment failure or success as evidenced by culture result (for rifampicin resistant patients)
Time frame: At Month 20 for rifampicin resistant patients
Relapse ascertainment (by questioning and retrospective check of microscopy evidence in TB clinics)
Time frame: At Month 18 for new patients; at Month 20 for retreatment patients; at Month 32 for rifampicin resistant patients
Chest X-ray findings
Time frame: At enrollment
Culture positivity
Time frame: At enrollment
Phenotypic Drug-resistance or susceptibility
Time frame: At enrollment (if positive culture)
Genotypic resistance to rifampin (GeneXpert)
Time frame: At enrollment
(Phenotypic)Type of Mycobacteria (tuberculous or non-tuberculous)
Time frame: At enrollment (if positive culture)
(Mpt64's)Type of Mycobacteria (tuberculous or non-tuberculous)
Time frame: At enrollment (if positive culture)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Background: PubMed 19275790Affolabi 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.
- Background: PubMed 16519816Brudey 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.
- Background: PubMed 20927191de 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.
- Background: PubMed 18702608de 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.
- Background: PubMed 16184053de 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.
- Background: PubMed 24143198Gehre 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.
- Background: PubMed 19624936Affolabi 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.
- Background: PubMed 9157152Kamerbeek 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.
- Background: PubMed 17448936Gagneux 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.
- Background: PubMed 91078Castets M. [Mycobacterium africanum (author's transl)]. Med Trop (Mars). 1979 Mar-Apr;39(2):145-8. French.
- Background: PubMed 14605204Parwati 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.
- Background: PubMed 25569290Asante-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.
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
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. This study is not recruiting at the moment.
Dissou Affolabi, MD PhD Prof principal investigator
Laboratoire de Référence des Mycobactéries, Benin
Bouke de Jong, MD PhD Prof principal investigator
Institute of Tropical Medicine, Belgium
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Laboratoire de Référence des Mycobactéries at 26 sites in 2 countries.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Benin, Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lineage (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02744469, which also lists 15 linked publications.
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 23 Feb 2021.