An observational study in Tuberculosis, sponsored by Laboratoire de Référence des Mycobactéries. Completed at 26 sites in 2 countries. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2021-02-23.
Sponsored by Laboratoire de Référence des Mycobactéries · Observational
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.
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.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's enrollment of 1,490 is above the median of 253 across 317 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →This is the only study on the registry with Laboratoire de Référence des Mycobactéries as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
''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 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)
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.
Time frame: At enrollment
Spoligotype (family)
Mycobacterium tuberculosis spoligotype (family) as determined by the spoligotyping pattern. The lineage will be determined using the specimen collected at participant enrolment.
Time frame: 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.
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)
Treatment failure will be ascertained at the end of the 20 months treatment period by culturing sputa from rifampicin resistant participants.
Time frame: 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.
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
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.
Time frame: At enrollment
Culture positivity
Isolation of mycobacteria (in vitro mycobacterial growth) in culture
Time frame: At enrollment
Phenotypic Drug-resistance or susceptibility
Drug resistance as determined using phenotypic drug susceptibility testing on 1st and 2nd line anti-tuberculous drugs
Time frame: At enrollment (if positive culture)
Genotypic resistance to rifampin (GeneXpert)
Resistance of Mycobacterium tuberculosis to rifampin as determined using the GeneXpert Mtb/Rif test.
Time frame: 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
Time frame: 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
Time frame: At enrollment (if positive culture)
Acid-Fast Bacilli microcopy result
Acid-Fast Bacilli microcopy result on patients' sputa determined using the Ziehl-Neelsen method or the auramine method depending on which of these methods is used at the various tuberculosis clinics where participants will be enrolled.
Time frame: 1 Day
Acid-Fast Bacilli microcopy on pooled sputum
Acid-Fast Bacilli microcopy result on the pooled sputum of each participant. The pooled sputum results from the addition of the 2 leftover routine sputa of a participant to the third sputum given after informed consent. This Acid-Fast Bacilli microcopy on pooled sputum will be done after shipment of the pooled sputum to the Reference Laboratory (LRM), using auramine method.
Time frame: At enrollment
Drug resistance or susceptibility (Novel diagnostic tests)
Drug resistance pattern for 1st and 2nd lines drugs using novel diagnostic tests.
Time frame: At enrollment
Ran from Apr 2016 to primary completion in Jan 2018, 20 months.
Of 122 non-industry observational studies under Tuberculosis, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 76. This study's 20 months is below that.
Counting every sponsor, half of 134 studies reached it within 36 months; a quarter within 21 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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