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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02573623

Acronym

PROMISE-TB

Enrollment

300

Registered

2015-10-12

Start date

2013-07-31

Completion date

2015-12-31

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Tuberculosis

Keywords

Immunology diagnosis test, Children, Zambia

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 15 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Countries

Zambia

Contacts

Primary ContactChipepo Kandasa, MD, PhD

ckankasa@zamnet.zm+260 211 251662

Backup ContactMwiya Miwya, MD

mwiya2002@yahoo.com+260 211 257535

Outcome results