Epidemiological Study In Tuberculosis-Endemic Urban Area in Senegal
NCT ID: NCT03767946
Last Updated: 2022-07-28
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
500 participants
OBSERVATIONAL
2018-07-27
2022-07-27
Brief Summary
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Detailed Description
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The primary objective is to estimate the prevalence of TB infection by the QuantiFERON-TB Gold Plus technique in 500 children splined in 1-year, 2-year, 5-year, and 12-year-old age groups living in the study area (Saint Louis, Senegal).
Secondary objectives are:
* To study the socio-demographic characteristics, the vaccination history of each subject and the possible tuberculous contacts he has.
* To map selected populations (from GPS residence data) according to the status (infected or uninfected) of each subject.
* To ensure the orientation of children found positive by the QuantiFERON-TB Gold Plus test for care and follow-up related to the TB diagnosis and treatment at one of the Health Centers (THC) located in the study areas.
* To estimate the number of tuberculosis cases detected in children aged up to 12 years and resident in the study area from THC registries and data from the National Tuberculosis Control Plan (PNB).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Children both genders according to age:
\*1-year old children (12 months -1/+4 months); n=125 at the date of recruitment.
Quantiferon Gold Plus Test
Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.
Group 2
Children both genders according to age:
\*2-year-old children (24 months -1/+4 months); n=125 at the date of recruitment.
Quantiferon Gold Plus Test
Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.
Group 3
Children both genders according to age:
\*5-year old children (60 months +/- 6 months); n=125 at the date of recruitment.
Quantiferon Gold Plus Test
Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.
Group 4
Children both genders according to age:
\*12-years old children (12 years old +/- 6 months); n=125 at the date of recruitment.
Quantiferon Gold Plus Test
Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.
Interventions
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Quantiferon Gold Plus Test
Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.
Eligibility Criteria
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Inclusion Criteria
* Obtaining written consent from one of the parents / guardians.
* Children meeting one the following age criterion:
* 1-year old child (12 months -1/+4 months);
* 2-year-old child (24 months -1/+4 months);
* 5-year old child (60 months +/-6 months);
* 12-year old child (12 years old +/-6 months);
Exclusion Criteria
* Participation refusal by one of the parents / guardians.
* Objection of the child belonging to the 12-year old group.
* Child with a known chronic pathology (severe asthma, epilepsy, type 1 diabetes, severe immunosuppression ...)
* Child considered by the Principal Investigator as medically unfit to participate in the study.
11 Months
12 Years
ALL
Yes
Sponsors
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Biofabri, S.L
INDUSTRY
TuBerculosis Vaccine Initiative
OTHER
Universidad de Zaragoza
OTHER
University of Cape Town
OTHER
Institut Pasteur de Madagascar
OTHER
Biomedical Research Center EPLS
OTHER
Responsible Party
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Gilles Riveau, PharmD, PhD
CEO
Principal Investigators
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Amadou T LY
Role: PRINCIPAL_INVESTIGATOR
Biomedical Research Center EPLS
Locations
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Biomedical Research Center EPLS
Saint-Louis, , France
Countries
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References
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Arbues A, Aguilo JI, Gonzalo-Asensio J, Marinova D, Uranga S, Puentes E, Fernandez C, Parra A, Cardona PJ, Vilaplana C, Ausina V, Williams A, Clark S, Malaga W, Guilhot C, Gicquel B, Martin C. Construction, characterization and preclinical evaluation of MTBVAC, the first live-attenuated M. tuberculosis-based vaccine to enter clinical trials. Vaccine. 2013 Oct 1;31(42):4867-73. doi: 10.1016/j.vaccine.2013.07.051. Epub 2013 Aug 17.
Marinova D, Gonzalo-Asensio J, Aguilo N, Martin C. MTBVAC from discovery to clinical trials in tuberculosis-endemic countries. Expert Rev Vaccines. 2017 Jun;16(6):565-576. doi: 10.1080/14760584.2017.1324303. Epub 2017 May 12.
Cuevas LE, Browning R, Bossuyt P, Casenghi M, Cotton MF, Cruz AT, Dodd LE, Drobniewski F, Gale M, Graham SM, Grzemska M, Heinrich N, Hesseling AC, Huebner R, Jean-Philippe P, Kabra SK, Kampmann B, Lewinsohn D, Li M, Lienhardt C, Mandalakas AM, Marais BJ, Menzies HJ, Montepiedra G, Mwansambo C, Oberhelman R, Palumbo P, Russek-Cohen E, Shapiro DE, Smith B, Soto-Castellares G, Starke JR, Swaminathan S, Wingfield C, Worrell C. Evaluation of tuberculosis diagnostics in children: 2. Methodological issues for conducting and reporting research evaluations of tuberculosis diagnostics for intrathoracic tuberculosis in children. Consensus from an expert panel. J Infect Dis. 2012 May 15;205 Suppl 2(Suppl 2):S209-15. doi: 10.1093/infdis/jir879. Epub 2012 Apr 3.
Nemes E, Rozot V, Geldenhuys H, Bilek N, Mabwe S, Abrahams D, Makhethe L, Erasmus M, Keyser A, Toefy A, Cloete Y, Ratangee F, Blauenfeldt T, Ruhwald M, Walzl G, Smith B, Loxton AG, Hanekom WA, Andrews JR, Lempicki MD, Ellis R, Ginsberg AM, Hatherill M, Scriba TJ; C-040-404 Study Team and the Adolescent Cohort Study Team. Optimization and Interpretation of Serial QuantiFERON Testing to Measure Acquisition of Mycobacterium tuberculosis Infection. Am J Respir Crit Care Med. 2017 Sep 1;196(5):638-648. doi: 10.1164/rccm.201704-0817OC.
Other Identifiers
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RIA2016V-1637
Identifier Type: -
Identifier Source: org_study_id
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