Evaluation of an Innovative Tuberculosis Diagnostic Test

HIV Clinical Trial

— PROMISE-TB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02573623
• Other study ID #: ANRS12293 PROMISE-TB
• Status: Recruiting
• Phase: N/A
• First received: September 22, 2015
• Last updated: October 9, 2015
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: October 2015
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: Chipepo Kandasa, MD, PhD
• Phone: +260 211 251662
• Email: ckankasa[@]zamnet.zm
• Is FDA regulated: No
• Health authority: Zambia: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• HIV
• Tuberculosis

Locations

Country	Name	City	State
Zambia	Department of Paediatrics and Child Health, University Teaching Hospital.UNZA-SOM	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	European and Developing Countries Clinical Trials Partnership (EDCTP)

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of children with tuberculosis who are correctly identified by a immunoenzymatic test for tuberculosis as having the condition		baseline	No
Primary	Proportion of tuberculosis negative children who are correctly identified as such by a immunoenzymatic test for tuberculosis		baseline	No