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

August 4, 2015 updated by: ANRS, Emerging Infectious Diseases

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
441

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Burkina Faso
      • Bobo Dioulasso, Burkina Faso
        • CHU Souro Sanou
  • Cambodia
      • Phnom Penh, Cambodia
        • National Pediatric Hospital
      • Siem Reap, Cambodia
        • Angkor Hospital for Children
  • Cameroon
      • Yaounde, Cameroon
        • Centre Hospitalier d'Essos
      • Yaounde, Cameroon
        • Centre Mère Enfant Chantal Biya
  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Pediatric Hospital Nhi Dong 1
      • Ho Chi Minh City, Vietnam
        • Pediatric Hospital Nhi Dong 2
      • Ho chi Minh ville, Vietnam
        • Pham Ngoc Thach Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tuberculosis diagnostic algorithm
Time Frame: 3 years

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of the QuantiFERON(R)-TB Gold In-Tube
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months

To assess the feasibility of the following TB sampling procedures:

  • the string test
  • the nasopharyngeal aspirate
  • stool sample
6 months
Evaluation of the morbidity (IRIS, drug toxicity and other opportunistic infections) and mortality in TB-HIV co-infected children
Time Frame: at 6 month of TB treatment
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)
Time Frame: 6 months

To assess the performance of the following TB sampling procedures:

  • the string test
  • the nasopharyngeal aspirate
  • stools sample
6 months
Evaluation of the Xpert MTB/RIF assay
Time Frame: 6 months
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)
Time Frame: 6 months
6 months
Comparison of the performance Xpert MTB/RIF assay on sampling methods other than the reference method (gastric aspirate and sputum)
Time Frame: 6 months

Evaluation of the Xpert MTB/RIF assay on the following sampling methods:

  • String test
  • Nasopharyngeal aspirates
  • Stool samples
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ANRS, Emerging Infectious Diseases

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Groupe Hospitalier Pitie-Salpetriere
Centre Muraz
Children's Hospital Number 2, Ho Chi Minh City, Vietnam
Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam
Institut Pasteur, Cambodia
Centre Pasteur du Cameroun
National Pediatric Hospital, Cambodia
Angkor Hospital for Children
Pediatric Hospital Nhi Dong 1, Ho Chi Minh City, Vietnam
Hôpital Necker-Enfants Malades, Paris, France
CHRU Arnaud de Villeveuve, Montpellier, France
IRD, Yaounde, Cameroon
Fondation Chantal Biya,Yaounde, Cameroon
CHU Sourô Sanou, Bobo Dioulasso, Burkina Faso
Centre Hospitalier D'essos

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Olivier Marcy, MD, Institut Pasteur in Cambodia, Phnom Penh, Cambodia
  • Study Chair: Vibol Ung, MD, National Pediatric Hospital, Phnom Penh, Cambodia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANRS12229 PAANTHER 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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