Improving Diagnosis of Tuberculosis in HIV Infected Children in Asia (Cambodia, Vietnam)and Africa (Burkina Faso, Cameroon)

ANRS, Emerging Infectious Diseases

Status: Completed

Conditions: Pediatrics; Tuberculosis; HIV

Treatments: Other: Development of a diagnosis algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT01331811

ANRS12229 PAANTHER 01

Details and patient eligibility

About

Childhood tuberculosis (TB) accounts for 11% of the total 9 million annual TB cases and the difficulty of its diagnosis is increased in case of HIV infection in children.

The aim of this study is to improve TB diagnosis in HIV-infected children by developing a new diagnostic algorithm incorporating new tools available such as:

• interferon gamma release assays (IGRAs), as alternative to the tuberculin skin test
• alternative specimen collection methods such as string test (or Enterotest (R)), nasopharyngeal aspirates and stools samples, as alternatives to gastric aspirate
• the Xpert MTB/RIF assay

Enrollment: 441 patients

Sex: All

Ages: Under 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children aged from 0 to 13 years
• confirmed HIV infection
• suspicion of tuberculosis
• informed consent signed by at least one parent or guardian
• on ARVs or not

Exclusion criteria

• history of anti TB treatment started in the past 2 years
• on going tuberculosis treatment
• Suspicion of exclusive extra-thoracic tuberculosis

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)