Benin Population Diversity of Tuberculosis and Implications

NCT02744469 | Completed

• 5 other identifiers: LRM-N°030-15/12/2015CNERS N°030 of 15th/12/2015ITM- N°1040/15EC UZA 15/49/532Belg registN°:B300201526865
• Study Type: observational
• Target: 1,490
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Tuberculosis

Keywords

Tuberculosis; population structure; implications; lineages; spoligotyping; sputum; resistance; culture; diagnostics; outcome; new/retreatment patient

Outcome Measures

Primary Outcomes (1)

• 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.

  At enrollment

Secondary Outcomes (10)

• Spoligotype (family)

  At enrollment

• Treatment failure or success as evidenced by microscopy result (for new and retreatment patients)

  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)

  At Month 20 for rifampicin resistant patients

• Relapse ascertainment (by questioning and retrospective check of microscopy evidence in TB clinics)

  At Month 18 for new patients; at Month 20 for retreatment patients; at Month 32 for rifampicin resistant patients

• Chest X-ray findings

  At enrollment

Other Outcomes (3)

• Acid-Fast Bacilli microcopy result

  1 Day

• Acid-Fast Bacilli microcopy on pooled sputum

  At enrollment

• Drug resistance or susceptibility (Novel diagnostic tests)

  At enrollment

Study Arms (2)

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.

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.

Other: No intervention (observational study)

Interventions

No intervention (observational study) OTHER

New patients; Retreatment patients

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratoire de Référence des Mycobactéries: lead
• Direction Générale de la Coopération au Développement, Belgique: collaborator
• Institute of Tropical Medicine, Belgium: collaborator
• Universiteit Antwerpen: collaborator
• Laboratoire de Référence des Mycobactéries, Benin republic: collaborator
• Centre National Hospitalier Universitaire de Pneumo-Phtisiologie de Cotonou, Benin: collaborator
• Centres de Diagnostic et de Traitement de la tuberculose, National Tuberculosis Programme, Benin: collaborator

Study Sites (26)

Institute of Tropical Medicine

Antwerp, Belgium

Location

Centre de Diagnostic et de Traitement de la Tuberculose de Djougou

Djougou, Atacora/Donga, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose de Matéri

Matéri, Atacora/Donga, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose de Natitingou

Natitingou, Atacora/Donga, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose de Tanguiéta

Tanguiéta, Atacora/Donga, Benin

Location

Centre de Diagnostic et de Traitement de la tuberculose d'Abomey-Calavi

Abomey-Calavi, Atlantique/Littoral, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose d'Allada

Allada, Atlantique/Littoral, Benin

Location

Centre National Hospitalier Universitaire de Pneumo-Phtisiologie de Cotonou

Cotonou, Atlantique/Littoral, 01BP321, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose de Ouidah

Ouidah, Atlantique/Littoral, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose de Bembèrèkè HE

Bembèrèkè, Borgou/Alibori, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose de Kandi

Kandi, Borgou/Alibori, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose de Nikki Hopital Sounou-Séro

Nikki, Borgou/Alibori, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose de Parakou CSCom

Parakou, Borgou/Alibori, Benin

Location

Laboratoire de Référence des Mycobactéries

Cotonou, Littoral Department, 01BP321, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose d'Aplahoué

Aplahoué, Mono/Couffo, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose de Bopa

Bopa, Mono/Couffo, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose de Comè

Comè, Mono/Couffo, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose de Houéyogbé

Péda-Houéyogbé, Mono/Couffo, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose de Avrankou

Avrankou, Oueme/Plateau, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose de Pobè

Pobé, Oueme/Plateau, Benin

Location

Centre de Pneumo-Phtisiologie d'Akron

Porto-Novo, Oueme/Plateau, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose de Sakété

Sakété, Oueme/Plateau, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose d'Abomey

Abomey, Zou/Collines, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose de Bohicon

Bohicon, Zou/Collines, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose de Dassa-Zoumè

Dassa-Zoumè, Zou/Collines, Benin

Location

Centre de Diagnostic et de Traitement de la Tuberculose de Zagnanado

Zagnanado, Zou/Collines, Benin

Location

Related Publications (15)

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• 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.

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• 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.

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Biospecimen

Retention: SAMPLES WITH DNA

Sputa will be collected at enrolment. Participants will be asked to provide an additional (third) sputum. For the purpose of this study, this sputum will be added to the leftover 2 sputa provided for the routine diagnosis of tuberculosis in order to reach in total at least 5 mL sputum. DNA will be extracted from a part of the sputum for the genotypic characterization Mycobacterium tuberculosis (spoligotype analysis).

MeSH Terms

Conditions

Tuberculosis

Interventions

Observation

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Dissou Affolabi, MD PhD Prof

  Laboratoire de Référence des Mycobactéries, Benin

  PRINCIPAL INVESTIGATOR

• Bouke de Jong, MD PhD Prof

  Institute of Tropical Medicine, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 20, 2016
• Study Start: April 12, 2016
• Primary Completion: January 8, 2018
• Study Completion: December 12, 2019
• Last Updated: February 23, 2021

Record last verified: 2021-02

Locations

BE (1)