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

This study is ongoing, but not recruiting participants.
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, Paris, France
Groupe Hospitalier Pitie-Salpetriere, Paris, France
CHRU Arnaud de Villeveuve, Montpellier, France
IRD, Yaounde, Cameroon
Fondation Chantal Biya,Yaounde, Cameroon
CHU Sourô Sanou, Bobo Dioulasso, Burkina Faso
Centre Muraz
Centre Pasteur du Cameroun, Yaounde, Cameroon
Caisse d'Essos Hospital, Yaounde, Cameroon
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)
ClinicalTrials.gov Identifier:
NCT01331811
First received: April 4, 2011
Last updated: July 11, 2014
Last verified: July 2014
  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 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

Condition Intervention
HIV
Tuberculosis
Pediatrics
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 diagnostic algorithm [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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 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 children.

  • Percentage of TB diagnosis sampling procedures actually performed [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Comparison of the performance Xpert MTB/RIF assay on sampling methods other than the reference method (gastric aspirate and sputum) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

    • String test
    • Nasopharyngeal aspirates
    • Stool samples


Enrollment: 441
Study Start Date: April 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 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
    • 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.

  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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Burkina Faso
CHU Sourô Sanou
Bobo Dioulasso, Burkina Faso
Cambodia
National Pediatric Hospital
Phnom Penh, Cambodia
Angkor Hospital for Children
Siem Reap, Cambodia
Cameroon
Centre Mère Enfant Chantal Biya
Yaounde, Cameroon
Centre Hospitalier d'Essos
Yaounde, Cameroon
Vietnam
Pediatric Hospital Nhi Dong 1
Ho Chi Minh City, Vietnam
Pediatric Hospital Nhi Dong 2
Ho Chi Minh City, Vietnam
Pham Ngoc Thach Hospital
Ho chi Minh ville, Vietnam
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
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, Paris, France
Groupe Hospitalier Pitie-Salpetriere, Paris, France
CHRU Arnaud de Villeveuve, Montpellier, France
IRD, Yaounde, Cameroon
Fondation Chantal Biya,Yaounde, Cameroon
CHU Sourô Sanou, Bobo Dioulasso, Burkina Faso
Centre Muraz
Centre Pasteur du Cameroun, Yaounde, Cameroon
Caisse d'Essos Hospital, Yaounde, Cameroon
Investigators
Study Chair: Olivier Marcy, MD Institut Pasteur in Cambodia, Phnom Penh, Cambodia
Study Chair: Vibol Ung, 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)
ClinicalTrials.gov Identifier: NCT01331811     History of Changes
Other Study ID Numbers: ANRS12229 PAANTHER 01
Study First Received: April 4, 2011
Last Updated: July 11, 2014
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
Pediatrics
Asia
Africa

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

ClinicalTrials.gov processed this record on August 28, 2014