Evaluation of an Innovative Tuberculosis Diagnostic Test (PROMISE-TB)
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|ClinicalTrials.gov Identifier: NCT02573623|
Recruitment Status : Unknown
Verified October 2015 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).
Recruitment status was: Recruiting
First Posted : October 12, 2015
Last Update Posted : October 12, 2015
Diagnosis of tuberculosis (TB)in young children is a challenge due to atypical non-specific symptoms, difficulty to expectorate mucus, paucibacillary nature of pulmonary TB and low sensitivity of available diagnostic tools.
This project aims at evaluating two innovative immunological methods for diagnosing of active TB among HIV-infected and uninfected children.
|Condition or disease|
The study is designed as a prospective study for the evaluation of diagnostic tests.
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Evaluation, of Innovative Tuberculosis Diagnostic Tests - Promoting Infant Health and Nutrition in Sub-Saharian Africa (PROMISE Consortium)|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||December 2015|
HIV-infected children with confirmed TB
Hospitalized children with TB confirmed by culture or GeneXpert
HIV-uninfected children aged<5 years with confirmed TB
Hospitalized children aged<5 years with TB confirmed by culture or GeneXpert
HIV-uninfected children aged>4 years with confirmed TB
Hospitalized children aged>4 years with TB confirmed by culture or GeneXpert
HIV-infected control children
Children hospitalized in the surgery ward without any evidence of tuberculosis infection
HIV-uninfected controls aged <5 years
Children <5 years hospitalized in the surgery ward without any evidence of tuberculosis infection
HIV-uninfected controls aged >4 years
Children >4 years hospitalized in the surgery ward without any evidence of tuberculosis infection
- Proportion of children with tuberculosis who are correctly identified by a immunoenzymatic test for tuberculosis as having the condition [ Time Frame: baseline ]
- Proportion of tuberculosis negative children who are correctly identified as such by a immunoenzymatic test for tuberculosis [ Time Frame: baseline ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02573623
|Contact: Chipepo Kandasa, MD, PhD||+260 211 email@example.com|
|Contact: Mwiya Miwya, MD||+260 211 firstname.lastname@example.org|
|Department of Paediatrics and Child Health, University Teaching Hospital.UNZA-SOM||Recruiting|
|Contact: Mwiya Miwya, MD +260 211 257535 email@example.com|
|Study Director:||Edouard Tuaillon, MD, PhD||Université de Montpellier, France|
|Study Director:||Chipepo Kankasa, MD, PhD||University of Zambia, Zambia|
|Study Chair:||Philippe Van de Perre, MD, PhD||Université de Montpellier, France|
|Principal Investigator:||Nicolas Nagot, MD, PhD||Université de Montpellier, France|