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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

April 4, 2011
July 11, 2014
April 2011
December 2014   (final data collection date for primary outcome measure)
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
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 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
  • 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 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
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • HIV
  • Tuberculosis
  • Pediatrics
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.

Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
441
December 2015
December 2014   (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
  • 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
Both
up to 13 Years
No
Contact information is only displayed when the study is recruiting subjects
Burkina Faso,   Cambodia,   Cameroon,   Vietnam
 
NCT01331811
ANRS12229 PAANTHER 01
No
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
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
Study Chair: Olivier Marcy, MD Institut Pasteur in Cambodia, Phnom Penh, Cambodia
Study Chair: Vibol Ung, 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)
July 2014

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