Evaluation of an Innovative Tuberculosis Diagnostic Test (PROMISE-TB)

ANRS, Emerging Infectious Diseases

Status: Unknown

Conditions: Tuberculosis; HIV

Study type: Observational

Funder types: Other

Identifiers

NCT02573623

ANRS12293 PROMISE-TB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: Under 15 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

300 participants in 6 patient groups

HIV-infected children with confirmed TB

Description:

Hospitalized children with TB confirmed by culture or GeneXpert

HIV-uninfected children aged<5 years with confirmed TB

Description:

Hospitalized children aged\<5 years with TB confirmed by culture or GeneXpert

HIV-uninfected children aged>4 years with confirmed TB

Description:

Hospitalized children aged\>4 years with TB confirmed by culture or GeneXpert

HIV-infected control children

Description:

Children hospitalized in the surgery ward without any evidence of tuberculosis infection

HIV-uninfected controls aged <5 years

Description:

Children \<5 years hospitalized in the surgery ward without any evidence of tuberculosis infection

HIV-uninfected controls aged >4 years

Description:

Children \>4 years hospitalized in the surgery ward without any evidence of tuberculosis infection