NCT01331811

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

Improving Diagnosis of Tuberculosis in HIV Infected Children in Asia (Cambodia, Vietnam) and Africa (Burkina Faso, Cameroon) ANRS 12229 PAANTHER 01 (Pediatric Asian African Network for Tuberculosis and HIV Research)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 441 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• HIV
• Tuberculosis
• Pediatrics

Interventions

Type	Name	Description
OTHER	Development of a diagnosis algorithm	At entry in the study, HIV infected children with suspected tuberculosis will undergo a complete evaluation including: * interview on anamnesis * clinical examination * evaluation of HIV infection stage * hematology and biochemistry tests * CD4 count * HIV viral load * IGRA * chest radiograph * Abdominal ultrasonograph to detect abdominal lymphadenopathy * Tuberculin skin test * gastric aspirates, sputum and string tests according to the age of children * nasopharyngeal aspirate * stool sample * lymph node fine needle aspirate or other specimen collection if applicable Diagnosis and treatment of all participating children will be done according to national guidelines. The children will be followed-up for 6 months until the end of their anti-TB treatment. For the analysis of data and the validation of the algorithm, children will be randomized into 2 groups. Data from Group I will be used to develop the algorithm; data from Group II will be used to validate it.

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-03-01
• Completion: 2014-05-01
• First posted: 2011-04-08
• Last updated: 2015-08-05

Locations

8 sites across 4 countries: Burkina Faso, Cambodia, Cameroon, Vietnam