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

This study is currently recruiting participants.
Verified May 2012 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
Collaborators:
Pasteur Institute in Cambodia
National Pediatric Hospital, Cambodia
Angkor Hospital for Children
Pham Ngoc Thach Hospital, Vietnam
Pediatric Hospital Nhi Dong 1, Ho Chi Minh City, Vietnam
Pediatric Hospital Nhi Dong 2, Ho Chi Minh City, Vietnam
Hôpital Necker-Enfants Malades
Groupe Hospitalier Pitie-Salpetriere
CHRU Arnaud de Villeveuve, Montpellier, France
IRD, Yaounde, Cameroon
Fondation Chantal Biya,Yaounde, Cameroon
CHU Sourô Sanou, Bobo Dioulasso, Burkina Faso
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier:
NCT01331811
First received: April 4, 2011
Last updated: May 11, 2012
Last verified: May 2012
History of Changes

April 4, 2011
May 11, 2012
April 2011
May 2013   (final data collection date for primary outcome measure)
Tuberculosis diagnosis assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Tubercolosis diagnosis assessement is based on the following exams results:

  • Clinical examination
  • Chest X-rays
  • Addominal ultrasound
  • IGRAs
  • Gastric aspirate
  • String test
  • Nasopharyngeal aspirate
  • Stools sample
  • sputum
Tuberculosis diagnosis assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Tubercolosis diagnosis assessement is based on the following exams results:

  • Clinical examination
  • Chest X-rays
  • Addominal ultrasound
  • IGRAs
  • Gastric aspirate
  • Sting test
  • Nasopharyngeal aspirate
  • Stools sample
Complete list of historical versions of study NCT01331811 on ClinicalTrials.gov Archive Site
  • Evaluation of the QuantiFERON(R)-TB Gold In-Tube [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 chhildren.
  • Percentage of TB diagnosis sampling procedures actually performed [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    To assess feasibility of the following TB diagnosis evaluated procedures:

    • the string test
    • the nasopharyngeal aspirate
    • stools 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 ] [ Designated as safety issue: Yes ]
  • Specificity and sensibility of TB diagnosis sampling procedures compared to TB diagnosis gold standard (sputum culture) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    To assess performance of the following TB diagnosis evaluated procedures:

    • the string test
    • the nasopharyngeal aspirate
    • stools sample
  • Evaluation of the QuantiFERON(R)-TB Gold In-Tube [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 chhildren.
  • Percentage of TB diagnosis sampling procedures actually performed [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    To assess feasibility of the following TB diagnosis evaluated procedures:

    • the string test
    • the nasopharyngeal aspirate
    • stools 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 ] [ Designated as safety issue: Yes ]
  • Specificity and sensibility of TB diagnosis sampling procedures compared to TB diagnosis gold standard (sputum culture) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    To assess performance of the following TB diagnosis evaluated procedures:

    • the string test
    • the nasopharyngeal aspirate
    • stools sample
Not Provided
Not Provided
 
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)

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 the 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. The IGRAs are immunology test measuring the secretion of interferon-gamma by lymphocytes activated by specific Mycobacterium tuberculosis complex antigens
  • alternative specimen collection methods such as string test (or Enterotest (R)), nasopharyngeal aspirates and stools samples, as alternatives to gastric aspirate
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • HIV
  • Tuberculosis
  • Pediatric
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

    -Laboratory analysis:

  • hematology and biochemistry tests
  • CD4 cells count
  • HIV viral load

  • Interferon Gamma Release Assay

    -Radiology:

  • chest radiograph

  • Abdominal ultrasonograph to detect abdominal lymphadenopathy

    • Tuberculin skin test
    • Bacteriological specimen collection:
  • 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 will be done according to national guidelines. The children will be followed-up for 6 months until the end of their anti-tuberculosis treatment.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
420
November 2013
May 2013   (final data collection date for primary outcome measure)

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

Exclusion Criteria:

  • history of anti TB treatment started in the past 2 years
  • on going tuberculosis treatment
  • Suspicion of exclusive extra-thoracic tuberculosis
Both
up to 13 Years
No
Contact: Olivier Marcy, MD +855 92 734 025 oliviermarcy@gmail.com
Contact: Laurance Borand, PharmD +855 12 333 671 lborand@pasteur-kh.org
Burkina Faso,   Cambodia,   Cameroon,   Vietnam
 
NCT01331811
ANRS12229 PAANTHER 01
Yes
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
French National Agency for Research on AIDS and Viral Hepatitis
  • Pasteur Institute in Cambodia
  • National Pediatric Hospital, Cambodia
  • Angkor Hospital for Children
  • Pham Ngoc Thach Hospital, Vietnam
  • Pediatric Hospital Nhi Dong 1, Ho Chi Minh City, Vietnam
  • Pediatric Hospital Nhi Dong 2, Ho Chi Minh City, Vietnam
  • Hôpital Necker-Enfants Malades
  • Groupe Hospitalier Pitie-Salpetriere
  • CHRU Arnaud de Villeveuve, Montpellier, France
  • IRD, Yaounde, Cameroon
  • Fondation Chantal Biya,Yaounde, Cameroon
  • CHU Sourô Sanou, Bobo Dioulasso, Burkina Faso
Study Chair: Olivier Marcy, MD Institut Pasteur in Cambodia, Phnom Penh, Cambodia
Study Chair: Sophan Sam, MD National Pediatric Hospital, Phnom Penh, Cambodia
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP