Evaluation of an Innovative Tuberculosis Diagnostic Test

• Conditions: Tuberculosis; HIV

• Registration Number: NCT02573623
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief Summary

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

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 Timeline

• Study Start: 2013-07
• Study First Submitted: 2015-09-22
• Status Verified: 2015-10
• Primary Completion: 2015-10
• Study First Submitted QC: 2015-10-09
• Last Update Submitted: 2015-10-09
• Study First Posted: 2015-10-12
• Last Update Posted: 2015-10-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Paediatrics and Child Health, University Teaching Hospital.UNZA-SOM; 🇿🇲 Lusaka, Zambia