Clinical trial NCT01331811: Improving Diagnosis of Tuberculosis in HIV Infected Children in Asia (Cambodia, Vietnam)and Africa (Burkina Faso, Cameroon)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Tuberculosis
Pediatrics
Keywords: HIV
Tuberculosis
Diagnosis
Pediatrics
Asia
Africa
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Institut Pasteur, Cambodia
name: National Pediatric Hospital, Cambodia
name: Angkor Hospital for Children
name: Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam
name: Pediatric Hospital Nhi Dong 1, Ho Chi Minh City, Vietnam
name: Number 2 Children's Hospital, Ho Chi Minh City
name: Hôpital Necker-Enfants Malades, Paris, France
name: Groupe Hospitalier Pitie-Salpetriere
name: CHRU Arnaud de Villeveuve, Montpellier, France
name: IRD, Yaounde, Cameroon
name: Fondation Chantal Biya,Yaounde, Cameroon
name: CHU Sourô Sanou, Bobo Dioulasso, Burkina Faso
name: Centre Muraz
name: Centre Pasteur du Cameroun
name: Centre Hospitalier D'essos
First posted: 2011-04-08
Enrollment: 441
Sex: ALL
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: Tuberculosis diagnostic algorithm
timeFrame: 3 years
Secondary outcomes:
measure: Evaluation of the QuantiFERON(R)-TB Gold In-Tube
timeFrame: 6 months
measure: Comparison of two in-vitro IGRAs
timeFrame: 6 months
measure: Percentage of TB diagnosis sampling procedures actually performed
timeFrame: 6 months
measure: Evaluation of the morbidity (IRIS, drug toxicity and other opportunistic infections) and mortality in TB-HIV co-infected children
timeFrame: at 6 month of TB treatment
measure: Specificity and sensibility of TB diagnosis sampling procedures compared to TB diagnosis gold standard (sputum or gastric aspirate culture)
timeFrame: 6 months
measure: Evaluation of the Xpert MTB/RIF assay
timeFrame: 6 months
measure: Comparison of the Xpert MTB/RIF test to the gold standard (culture of gastric aspirates or sputum)
timeFrame: 6 months
measure: Comparison of the performance Xpert MTB/RIF assay on sampling methods other than the reference method (gastric aspirate and sputum)
timeFrame: 6 months
Other outcomes:
Locations:
city: Bobo Dioulasso
country: Burkina Faso
facility: CHU Sourô Sanou
city: Phnom Penh
country: Cambodia
facility: National Pediatric Hospital
city: Siem Reap
country: Cambodia
facility: Angkor Hospital for Children
city: Yaounde
country: Cameroon
facility: Centre Hospitalier d'Essos
city: Yaounde
country: Cameroon
facility: Centre Mère Enfant Chantal Biya
city: Ho Chi Minh City
country: Vietnam
facility: Pediatric Hospital Nhi Dong 1
city: Ho Chi Minh City
country: Vietnam
facility: Pediatric Hospital Nhi Dong 2
city: Ho chi Minh ville
country: Vietnam
facility: Pham Ngoc Thach Hospital
Study officials:
affiliation: Institut Pasteur in Cambodia, Phnom Penh, Cambodia
name: Olivier Marcy, MD
role: STUDY_CHAIR
affiliation: National Pediatric Hospital, Phnom Penh, Cambodia
name: Vibol Ung, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.