Evaluation of an Innovative Tuberculosis Diagnostic Test

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation, of Innovative Tuberculosis Diagnostic Tests - Promoting Infant Health and Nutrition in Sub-Saharian Africa (PROMISE Consortium)

Conditions
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Tuberculosis, HIV

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for tuberculosis cases: one of 4 clinical signs 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 Inclusion Criteria for controls: children without any of the signs and symptoms quoted above

Ages Eligible for Study
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Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-infected children with confirmed TB<br>Hospitalized children with TB confirmed by culture or GeneXpert | |
| HIV-uninfected children aged<5 years with confirmed TB<br>Hospitalized children aged<5 years with TB confirmed by culture or GeneXpert | |
| HIV-uninfected children aged>4 years with confirmed TB<br>Hospitalized children aged>4 years with TB confirmed by culture or GeneXpert | |
| HIV-infected control children<br>Children hospitalized in the surgery ward without any evidence of tuberculosis infection | |
| HIV-uninfected controls aged <5 years<br>Children <5 years hospitalized in the surgery ward without any evidence of tuberculosis infection | |
| HIV-uninfected controls aged >4 years<br>Children >4 years hospitalized in the surgery ward without any evidence of tuberculosis infection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of children with tuberculosis who are correctly identified by a immunoenzymatic test for tuberculosis as having the condition |  | baseline | 
| Proportion of tuberculosis negative children who are correctly identified as such by a immunoenzymatic test for tuberculosis |  | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunology diagnosis test, Children, Zambia