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| Name | Class |
|---|---|
| Institut Pasteur, Cambodia | OTHER |
| National Pediatric Hospital, Cambodia | UNKNOWN |
| Angkor Hospital for Children | OTHER |
| Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam |
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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Development of a diagnosis algorithm | Other | At entry in the study, HIV infected children with suspected tuberculosis will undergo a complete evaluation including:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tuberculosis diagnostic algorithm | Development of an effective diagnostic algorithm for pediatric tuberculosis after evaluating the following diagnostic tests and sampling methods:
| 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the QuantiFERON(R)-TB Gold In-Tube | 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 | 6 months |
| Comparison of two in-vitro IGRAs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Marcy, MD | Institut Pasteur in Cambodia, Phnom Penh, Cambodia | Study Chair |
| Vibol Ung, MD | National Pediatric Hospital, Phnom Penh, Cambodia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Sourô Sanou | Bobo-Dioulasso | Burkina Faso | ||||
| National Pediatric Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31455612 | Derived | 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. | |
| 30689814 |
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| 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 | OTHER |
| 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 |
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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. |
| 6 months |
| Percentage of TB diagnosis sampling procedures actually performed | To assess the feasibility of the following TB sampling procedures:
| 6 months |
| Evaluation of the morbidity (IRIS, drug toxicity and other opportunistic infections) and mortality in TB-HIV co-infected children | 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) | To assess the performance of the following TB sampling procedures:
| 6 months |
| Evaluation of the Xpert MTB/RIF assay | Evaluate the sensitivity, specificity, positive and negative predictive values of the Xpert MTB/RIF assay | 6 months |
| Comparison of the Xpert MTB/RIF test to the gold standard (culture of gastric aspirates or sputum) | 6 months |
| Comparison of the performance Xpert MTB/RIF assay on sampling methods other than the reference method (gastric aspirate and sputum) | Evaluation of the Xpert MTB/RIF assay on the following sampling methods:
| 6 months |
| 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 |
| Derived |
| 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. |
| 29174612 | Derived | 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. |
| 26908804 | Derived | 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. |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D004194 | Disease |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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