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NCT Number: NCT01331811

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

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

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Key information

Conditions

HIV Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Disease Gram-Positive Bacterial Infections Infections Mycobacterium Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatrics Tuberculosis

Age range

Up to 13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Sourô Sanou, Bobo-Dioulasso, Burkina Faso

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Development of a diagnosis algorithm

Other

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.

Primary outcomes

  1. Tuberculosis diagnostic algorithm

    Time frame: 3 years

    Development of an effective diagnostic algorithm for pediatric tuberculosis after evaluating the following diagnostic tests and sampling methods:

    • Clinical examination
    • Chest X-rays
    • Abdominal ultrasound
    • IGRAs
    • Xpert MTB/RIF
    • Gastric aspirate
    • String test
    • Nasopharyngeal aspirate
    • Stools sample
    • Sputum samples

Secondary outcomes

  1. Evaluation of the QuantiFERON(R)-TB Gold In-Tube

    Time frame: 6 months

    Evaluation of the sensitivity, specificity, positive and negative predictive values of an in-vitro Interferon Gamma Release (IGRAs) : the QuantiFERON(R)-TB Gold iIn-Tube, for the diagnosis of TB in HIV infected children

  2. Comparison of two in-vitro IGRAs

    Time frame: 6 months

    Comparison of the performances of two in-vitro IGRAs: the QauntiFERON(R)-TB Gold In-Tube and the T.SPOT-TB(R), for the diagnosis of tuberculosis in a sub-group of HIV infected children.

  3. Percentage of TB diagnosis sampling procedures actually performed

    Time frame: 6 months

    To assess the feasibility of the following TB sampling procedures:

    • the string test
    • the nasopharyngeal aspirate
    • stool sample

  4. Evaluation of the morbidity (IRIS, drug toxicity and other opportunistic infections) and mortality in TB-HIV co-infected children

    Time frame: at 6 month of TB treatment

  5. Specificity and sensibility of TB diagnosis sampling procedures compared to TB diagnosis gold standard (sputum or gastric aspirate culture)

    Time frame: 6 months

    To assess the performance of the following TB sampling procedures:

    • the string test
    • the nasopharyngeal aspirate
    • stools sample

  6. Evaluation of the Xpert MTB/RIF assay

    Time frame: 6 months

    Evaluate the sensitivity, specificity, positive and negative predictive values of the Xpert MTB/RIF assay

  7. Comparison of the Xpert MTB/RIF test to the gold standard (culture of gastric aspirates or sputum)

    Time frame: 6 months

  8. Comparison of the performance Xpert MTB/RIF assay on sampling methods other than the reference method (gastric aspirate and sputum)

    Time frame: 6 months

    Evaluation of the Xpert MTB/RIF assay on the following sampling methods:

    • String test
    • Nasopharyngeal aspirates
    • Stool samples

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • Angkor Hospital for Children
  • CHRU Arnaud de Villeveuve, Montpellier, France
  • CHU Sourô Sanou, Bobo Dioulasso, Burkina Faso
  • Centre Hospitalier D'essos
  • Centre Muraz
  • Centre Pasteur du Cameroun
  • Fondation Chantal Biya,Yaounde, Cameroon
  • Groupe Hospitalier Pitie-Salpetriere
  • Hôpital Necker-Enfants Malades
  • IRD, Yaounde, Cameroon
  • Institut Pasteur, Cambodia
  • National Pediatric Hospital, Cambodia
  • Number 2 Children's Hospital, Ho Chi Minh City
  • Pediatric Hospital Nhi Dong 1, Ho Chi Minh City, Vietnam
  • Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam

Registry information

Official study title

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)

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 8, 2011
Registry last updated
Aug 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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