Clinical trial NCT02573623: Evaluation of an Innovative Tuberculosis Diagnostic Test
Official title: Evaluation, of Innovative Tuberculosis Diagnostic Tests - Promoting Infant Health and Nutrition in Sub-Saharian Africa (PROMISE Consortium)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tuberculosis
HIV
Keywords: Immunology diagnosis test
Children
Zambia
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: European and Developing Countries Clinical Trials Partnership (EDCTP)
First posted: 2015-10-12
Enrollment: 300
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 0 to 15 years with a definite diagnosis of tuberculosis infection, HIV-infected or uninfected.

They will be matched on age and HIV status, to an equivalent number of children without any evidence of tuberculosis infection.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of children with tuberculosis who are correctly identified by a immunoenzymatic test for tuberculosis as having the condition
timeFrame: baseline
measure: Proportion of tuberculosis negative children who are correctly identified as such by a immunoenzymatic test for tuberculosis
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Department of Paediatrics and Child Health, University Teaching Hospital.UNZA-SOM
Study officials:
affiliation: Université de Montpellier, France
name: Edouard Tuaillon, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Zambia, Zambia
name: Chipepo Kankasa, MD, PhD
role: STUDY_DIRECTOR
affiliation: Université de Montpellier, France
name: Philippe Van de Perre, MD, PhD
role: STUDY_CHAIR
affiliation: Université de Montpellier, France
name: Nicolas Nagot, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: