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:
Institut Pasteur, 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: July 3, 2013
Last verified: May 2012
  Purpose

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

Condition Intervention
HIV
Tuberculosis
Pediatric
Other: Development of a diagnosis algorithm

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official 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)

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 420
Study Start Date: April 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

  Eligibility

Ages Eligible for Study:   up to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331811

Contacts
Contact: Olivier Marcy, MD +855 92 734 025 oliviermarcy@gmail.com
Contact: Laurance Borand, PharmD +855 12 333 671 lborand@pasteur-kh.org

Locations
Burkina Faso
CHU Sourô Sanou Not yet recruiting
Bobo Dioulasso, Burkina Faso
Contact: Boubacar Nacro, MD    +226 20 97 00 44    bnacro@fasonet.bf   
Cambodia
National Pediatric Hospital Recruiting
Phnom Penh, Cambodia
Contact: Vibol Ung, MD    +855 11 858 165    u_vibol@yahoo.com   
Angkor Hospital for Children Not yet recruiting
Siem Reap, Cambodia
Contact: Leakheana Neou    +855 12 863 584    leakhena@angkorhospital.org   
Cameroon
Centre Mère Enfant Chantal Biya Not yet recruiting
Yaounde, Cameroon
Contact: Francis Ataba, MD    +237 77 33 00 55    atebfranc@yahoo.fr   
Vietnam
Pediatric Hospital Nhi Dong 1 Not yet recruiting
Ho Chi Minh City, Vietnam
Contact: Khanh Truong Huu, MD    +84 913 117 965    khanhnhiem@yahoo.com   
Pediatric Hospital Nhi Dong 2 Not yet recruiting
Ho Chi Minh City, Vietnam
Contact: Viet Do Chau    +84 903 779 576    dochauviet@yahoo.com   
Pham Ngoc Thach Hospital Not yet recruiting
Ho chi Minh ville, Vietnam
Contact: Nguyen Thi Ngoc Lan, MD    +84 903 829 817    ngoclan0456@yahoo.com   
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Institut Pasteur, 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
Investigators
Study Chair: Olivier Marcy, MD Institut Pasteur in Cambodia, Phnom Penh, Cambodia
Study Chair: Sophan Sam, MD National Pediatric Hospital, Phnom Penh, Cambodia
  More Information

No publications provided

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     History of Changes
Other Study ID Numbers: ANRS12229 PAANTHER 01
Study First Received: April 4, 2011
Last Updated: July 3, 2013
Health Authority: Cambodia: Ministry of Health
Vietnam: Ho Chi Minh City Health Service
Vietnam: Ministry of Health
Burkina Faso: Ministry of Health
Cameroon: Ministry of Health

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
HIV
Tuberculosis
Diagnosis
Pediatry
Asia
Africa

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 20, 2014