Improving Diagnosis of Tuberculosis in HIV Infected Children in Asia (Cambodia, Vietnam)and Africa (Burkina Faso, Cameroon)
NCT ID: NCT01331811
Last Updated: 2015-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
441 participants
INTERVENTIONAL
2011-04-30
2014-05-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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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 Criteria
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Inclusion Criteria
* confirmed HIV infection
* suspicion of tuberculosis
* informed consent signed by at least one parent or guardian
* on ARVs or not
Exclusion Criteria
* on going tuberculosis treatment
* Suspicion of exclusive extra-thoracic tuberculosis
13 Years
ALL
No
Sponsors
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Institut Pasteur, Cambodia
OTHER
National Pediatric Hospital, Cambodia
UNKNOWN
Angkor Hospital for Children
OTHER
Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam
OTHER
Pediatric Hospital Nhi Dong 1, Ho Chi Minh City, Vietnam
UNKNOWN
Number 2 Children's Hospital, Ho Chi Minh City
OTHER
Hôpital Necker-Enfants Malades, Paris, France
UNKNOWN
Groupe Hospitalier Pitie-Salpetriere
OTHER
CHRU Arnaud de Villeveuve, Montpellier, France
UNKNOWN
IRD, Yaounde, Cameroon
UNKNOWN
Fondation Chantal Biya,Yaounde, Cameroon
UNKNOWN
CHU Sourô Sanou, Bobo Dioulasso, Burkina Faso
UNKNOWN
Centre Muraz
OTHER
Centre Pasteur du Cameroun
OTHER
Centre Hospitalier D'essos
OTHER
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Olivier Marcy, MD
Role: STUDY_CHAIR
Institut Pasteur in Cambodia, Phnom Penh, Cambodia
Vibol Ung, MD
Role: STUDY_CHAIR
National Pediatric Hospital, Phnom Penh, Cambodia
Locations
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CHU Sourô Sanou
Bobo-Dioulasso, , Burkina Faso
National Pediatric Hospital
Phnom Penh, , Cambodia
Angkor Hospital for Children
Siem Reap, , Cambodia
Centre Hospitalier d'Essos
Yaoundé, , Cameroon
Centre Mère Enfant Chantal Biya
Yaoundé, , Cameroon
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 City, , Vietnam
Countries
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References
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Marcy O, Borand L, Ung V, Msellati P, Tejiokem M, Huu KT, Do Chau V, Ngoc Tran D, Ateba-Ndongo F, Tetang-Ndiang S, Nacro B, Sanogo B, Neou L, Goyet S, Dim B, Pean P, Quillet C, Fournier I, Berteloot L, Carcelain G, Godreuil S, Blanche S, Delacourt C; ANRS 12229 PAANTHER 01 STUDY GROUP. A Treatment-Decision Score for HIV-Infected Children With Suspected Tuberculosis. Pediatrics. 2019 Sep;144(3):e20182065. doi: 10.1542/peds.2018-2065.
Borand L, de Lauzanne A, Nguyen NL, Cheng S, Pham TH, Eyangoh S, Ouedraogo AS, Ung V, Msellati P, Tejiokem M, Nacro B, Inghammar M, Dim B, Delacourt C, Godreuil S, Blanche S, Marcy O; Pediatric Asian African Network for Tuberculosis and HIV Research (PAANTHER) Study Group. Isolation of Nontuberculous Mycobacteria in Southeast Asian and African Human Immunodeficiency Virus-infected Children With Suspected Tuberculosis. Clin Infect Dis. 2019 May 2;68(10):1750-1753. doi: 10.1093/cid/ciy897.
Marcy O, Tejiokem M, Msellati P, Truong Huu K, Do Chau V, Tran Ngoc D, Nacro B, Ateba-Ndongo F, Tetang-Ndiang S, Ung V, Dim B, Neou L, Berteloot L, Borand L, Delacourt C, Blanche S; ANRS 12229 PAANTHER 01 Study Group. Mortality and its determinants in antiretroviral treatment-naive HIV-infected children with suspected tuberculosis: an observational cohort study. Lancet HIV. 2018 Feb;5(2):e87-e95. doi: 10.1016/S2352-3018(17)30206-0. Epub 2017 Nov 23.
Marcy O, Ung V, Goyet S, Borand L, Msellati P, Tejiokem M, Nguyen Thi NL, Nacro B, Cheng S, Eyangoh S, Pham TH, Ouedraogo AS, Tarantola A, Godreuil S, Blanche S, Delacourt C. Performance of Xpert MTB/RIF and Alternative Specimen Collection Methods for the Diagnosis of Tuberculosis in HIV-Infected Children. Clin Infect Dis. 2016 May 1;62(9):1161-1168. doi: 10.1093/cid/ciw036. Epub 2016 Feb 7.
Other Identifiers
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ANRS12229 PAANTHER 01
Identifier Type: -
Identifier Source: org_study_id
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