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AzTrials

HIVNCT01331811

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

A study testing Development of a diagnosis algorithm in people with HIV and Tuberculosis, run by ANRS, Emerging Infectious Diseases at 8 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 13 years
Conditions the study is for
HIV, Tuberculosis, Pediatrics
What is being tested?
Development of a diagnosis algorithm
How many people
441 participants
Where
8 sitesin 4 countries
Study dates
Apr 2011to May 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

8 sites in 4 countries.

8 sites in 4 countries

Vietnam3 sites

  • Pediatric Hospital Nhi Dong 1

    Ho Chi Minh City

  • Pediatric Hospital Nhi Dong 2

    Ho Chi Minh City

  • Pham Ngoc Thach Hospital

    Ho Chi Minh City

Other trials in Vietnam

Cambodia2 sites

  • National Pediatric Hospital

    Phnom Penh

  • Angkor Hospital for Children

    Siem Reap

Other trials in Cambodia

Cameroon2 sites

  • Centre Hospitalier d'Essos

    Yaoundé

  • Centre Mère Enfant Chantal Biya

    Yaoundé

Other trials in Cameroon

Burkina Faso1 site

  • CHU Sourô Sanou

    Bobo-Dioulasso

Other trials in Burkina Faso

About this study

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)

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
Being tested
Development of a diagnosis algorithm
Keywords
HIV, Tuberculosis, Diagnosis, Pediatrics, Asia, Africa
Medical subject headings
Tuberculosis, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 years

Secondary outcomes (8)

  1. 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

    Measured: 6 months

  2. Comparison of two in-vitro IGRAs

    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.

    Measured: 6 months

  3. Percentage of TB diagnosis sampling procedures actually performed

    To assess the feasibility of the following TB sampling procedures:

    • the string test
    • the nasopharyngeal aspirate
    • stool sample

    Measured: 6 months

  4. Evaluation of the morbidity (IRIS, drug toxicity and other opportunistic infections) and mortality in TB-HIV co-infected children

    Measured: at 6 month of TB treatment

  5. 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:

    • the string test
    • the nasopharyngeal aspirate
    • stools sample

    Measured: 6 months

  6. Evaluation of the Xpert MTB/RIF assay

    Evaluate the sensitivity, specificity, positive and negative predictive values of the Xpert MTB/RIF assay

    Measured: 6 months

  7. Comparison of the Xpert MTB/RIF test to the gold standard (culture of gastric aspirates or sputum)

    Measured: 6 months

  8. 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:

    • String test
    • Nasopharyngeal aspirates
    • Stool samples

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionMar 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
441 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01331811
Sponsor's protocol ID
ANRS12229 PAANTHER 01
Status last verified
Aug 2015
First submitted
4 Apr 2011
Last updated
5 Aug 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31455612

  • 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.

    PubMed 30689814

  • 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.

    PubMed 29174612

  • 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.

    PubMed 26908804

Questions about this trial

What is this clinical trial studying?

A study testing Development of a diagnosis algorithm in people with HIV and Tuberculosis, run by ANRS, Emerging Infectious Diseases at 8 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Vietnam, Cambodia, Cameroon, Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tuberculosis diagnostic algorithm (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01331811, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2015.

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