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

Overview

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

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2014

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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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.
  • 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
  • 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
  • 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
  • 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
  • Comparison of the Xpert MTB/RIF test to the gold standard (culture of gastric aspirates or sputum)
    • Time Frame: 6 months
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 13 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
  • Collaborator
    • Institut Pasteur, Cambodia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Olivier Marcy, MD, Study Chair, Institut Pasteur in Cambodia, Phnom Penh, Cambodia
    • Vibol Ung, MD, Study Chair, National Pediatric Hospital, Phnom Penh, Cambodia

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