NCT02573623

Evaluation of an Innovative Tuberculosis Diagnostic Test

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tuberculosis
• HIV

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-10-01
• Completion: 2015-12-01
• First posted: 2015-10-12
• Last updated: 2015-10-12

Locations

1 site across 1 country: Zambia