Clinical Trials

MainTitle

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

This study has been completed
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
National Pediatric Hospital, Cambodia
Angkor Hospital for Children
Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam
Pediatric Hospital Nhi Dong 1, Ho Chi Minh City, Vietnam
Children's Hospital Number 2, Ho Chi Minh City, Vietnam
Hôpital Necker-Enfants Malades, Paris, France
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
Centre Muraz
Centre Pasteur du Cameroun
Centre Hospitalier D'essos

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: August 4, 2015
Last Verified: August 2015
History of Changes
Purpose

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
pert 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: None (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)

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 ]
    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 ]
    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

Enrollment: 441
Study Start Date: April 2011
Study Completion Date: May 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Eligibility

Eligibility

Ages Eligible for Study: up to 13 Years  
Sexes Eligible for Study: All  
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

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 Hospitalier d'Essos
Yaounde, Cameroon
Centre Mère Enfant Chantal Biya
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, Ho Chi Minh City, Vietnam
Pediatric Hospital Nhi Dong 1, Ho Chi Minh City, Vietnam
Children's Hospital Number 2, Ho Chi Minh City, Vietnam
Hôpital Necker-Enfants Malades, Paris, France
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
Centre Muraz
Centre Pasteur du Cameroun
Centre Hospitalier D'essos

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

More Information


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: August 4, 2015  

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

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.