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

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

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.

Sponsors & Collaborators

• Institut Pasteur, Cambodia

  collaborator OTHER

• National Pediatric Hospital, Cambodia

  collaborator UNKNOWN

• Angkor Hospital for Children

  collaborator OTHER

• Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam

  collaborator OTHER

• Pediatric Hospital Nhi Dong 1, Ho Chi Minh City, Vietnam

  collaborator UNKNOWN

• Number 2 Children's Hospital, Ho Chi Minh City

  collaborator OTHER

• Hôpital Necker-Enfants Malades, Paris, France

  collaborator UNKNOWN

• Groupe Hospitalier Pitie-Salpetriere

  collaborator OTHER

• CHRU Arnaud de Villeveuve, Montpellier, France

  collaborator UNKNOWN

• IRD, Yaounde, Cameroon

  collaborator UNKNOWN

• Fondation Chantal Biya,Yaounde, Cameroon

  collaborator UNKNOWN

• CHU Sourô Sanou, Bobo Dioulasso, Burkina Faso

  collaborator UNKNOWN

• Centre Muraz

  collaborator OTHER

• Centre Pasteur du Cameroun

  collaborator OTHER

• Centre Hospitalier D'essos

  collaborator OTHER

• ANRS, Emerging Infectious Diseases

  lead OTHER_GOV

Principal Investigators

• Olivier Marcy, MD · Institut Pasteur in Cambodia, Phnom Penh, Cambodia

• Vibol Ung, MD · National Pediatric Hospital, Phnom Penh, Cambodia

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

13 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2014-03-31

Completion

2014-05-31

Countries

• Burkina Faso
• Cambodia
• Cameroon
• Vietnam

Study Locations