NCT01331811

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
441

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable hiv

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

August 5, 2015

Status Verified

August 1, 2015

Enrollment Period

2.9 years

First QC Date

April 4, 2011

Last Update Submit

August 4, 2015

Conditions

HIVTuberculosisPediatrics

Keywords

HIVTuberculosisDiagnosisPediatricsAsiaAfrica

Outcome Measures

Primary Outcomes (1)

  • Tuberculosis diagnostic algorithm

    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

    3 years

Secondary Outcomes (8)

  • Evaluation of the QuantiFERON(R)-TB Gold In-Tube

    6 months

  • Comparison of two in-vitro IGRAs

    6 months

  • Percentage of TB diagnosis sampling procedures actually performed

    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)

    6 months

  • +3 more secondary outcomes

Interventions

Development of a diagnosis algorithmOTHER

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

AgeUp to 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • history of anti TB treatment started in the past 2 years
  • on going tuberculosis treatment
  • Suspicion of exclusive extra-thoracic tuberculosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

CHU Sourô Sanou

Bobo-Dioulasso, Burkina Faso

Location

National Pediatric Hospital

Phnom Penh, Cambodia

Location

Angkor Hospital for Children

Siem Reap, Cambodia

Location

Centre Hospitalier d'Essos

Yaoundé, Cameroon

Location

Centre Mère Enfant Chantal Biya

Yaoundé, Cameroon

Location

Pediatric Hospital Nhi Dong 1

Ho Chi Minh City, Vietnam

Location

Pediatric Hospital Nhi Dong 2

Ho Chi Minh City, Vietnam

Location

Pham Ngoc Thach Hospital

Ho Chi Minh City, Vietnam

Location

Related Publications (4)

  • 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.

    PMID: 31455612DERIVED

  • 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.

    PMID: 30689814DERIVED

  • 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.

    PMID: 29174612DERIVED

  • 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.

    PMID: 26908804DERIVED

MeSH Terms

Conditions

TuberculosisDisease

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier Marcy, MD

    Institut Pasteur in Cambodia, Phnom Penh, Cambodia

    STUDY CHAIR

  • Vibol Ung, MD

    National Pediatric Hospital, Phnom Penh, Cambodia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2011

First Posted

April 8, 2011

Study Start

April 1, 2011

Primary Completion

March 1, 2014

Study Completion

May 1, 2014

Last Updated

August 5, 2015

Record last verified: 2015-08

Locations

BU(1)VN(3)CA(2)