Evaluation of an Innovative Tuberculosis Diagnostic Test
NCT ID: NCT02573623
Last Updated: 2015-10-12
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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UNKNOWN
300 participants
OBSERVATIONAL
2013-07-31
2015-12-31
Brief Summary
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This project aims at evaluating two innovative immunological methods for diagnosing of active TB among HIV-infected and uninfected children.
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Detailed Description
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Children admitted with probable TB based on clinical and radiological symptoms are recruited. Gastric lavage or sputum on two to three consecutive days will be collected as per routine practise. Active TB will be defined as a positive GeneXpert diagnostic test or MTB culture.
In addition, children with no sign of TB will be recruited to estimate the specificity of the diagnostic tests. These children will be recruited from the surgical ward of the hospital, and matched for age group and HIV status.
In all children, blood samples will be drawn and stored to perform quantiferon (R) and the new tests under evaluation.
The analysis will evaluate the sensitivity and specificity of the tests against the current gold standard (detection of Mycobacterium tuberculosis (MTB) in any specimen obtained from the patient). Identification of diagnosis algorithms, including these tests if they prove to be informative, will be elaborated and evaluated.
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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HIV-infected children with confirmed TB
Hospitalized children with TB confirmed by culture or GeneXpert
No interventions assigned to this group
HIV-uninfected children aged<5 years with confirmed TB
Hospitalized children aged\<5 years with TB confirmed by culture or GeneXpert
No interventions assigned to this group
HIV-uninfected children aged>4 years with confirmed TB
Hospitalized children aged\>4 years with TB confirmed by culture or GeneXpert
No interventions assigned to this group
HIV-infected control children
Children hospitalized in the surgery ward without any evidence of tuberculosis infection
No interventions assigned to this group
HIV-uninfected controls aged <5 years
Children \<5 years hospitalized in the surgery ward without any evidence of tuberculosis infection
No interventions assigned to this group
HIV-uninfected controls aged >4 years
Children \>4 years hospitalized in the surgery ward without any evidence of tuberculosis infection
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* persistent and unexplained cough
* unexplained weight loss or failure to thrive
* persistent and unexplained fever
* persistent and unexplained lethargy or reduced playfulness
* chest X-Ray consistent with a tuberculosis infection
* an adenitis compatible with non-pulmonary tuberculosis Among these children only those with confirmed TB will be analysed for the primary outcome
* children without any of the signs and symptoms quoted above
15 Years
ALL
Yes
Sponsors
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European and Developing Countries Clinical Trials Partnership (EDCTP)
OTHER_GOV
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Edouard Tuaillon, MD, PhD
Role: STUDY_DIRECTOR
Université de Montpellier, France
Chipepo Kankasa, MD, PhD
Role: STUDY_DIRECTOR
University of Zambia, Zambia
Philippe Van de Perre, MD, PhD
Role: STUDY_CHAIR
Université de Montpellier, France
Nicolas Nagot, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Université de Montpellier, France
Locations
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Department of Paediatrics and Child Health, University Teaching Hospital.UNZA-SOM
Lusaka, , Zambia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ANRS12293 PROMISE-TB
Identifier Type: -
Identifier Source: org_study_id
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