Improving Diagnosis of Tuberculosis in HIV Infected Children in Asia (Cambodia, Vietnam)and Africa (Burkina Faso, Cameroon)
This study is currently recruiting participants.
Verified May 2012 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborators:
Pasteur Institute in Cambodia
National Pediatric Hospital, Cambodia
Angkor Hospital for Children
Pham Ngoc Thach Hospital, Vietnam
Pediatric Hospital Nhi Dong 1, Ho Chi Minh City, Vietnam
Pediatric Hospital Nhi Dong 2, Ho Chi Minh City, Vietnam
Hôpital Necker-Enfants Malades
Groupe Hospitalier Pitie-Salpetriere
CHRU Arnaud de Villeveuve, Montpellier, France
IRD, Yaounde, Cameroon
Fondation Chantal Biya,Yaounde, Cameroon
CHU Sourô Sanou, Bobo Dioulasso, Burkina Faso
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis )
ClinicalTrials.gov Identifier:
NCT01331811
First received: April 4, 2011
Last updated: May 11, 2012
Last verified: May 2012
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Purpose
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 the 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. The IGRAs are immunology test measuring the secretion of interferon-gamma by lymphocytes activated by specific Mycobacterium tuberculosis complex antigens
- alternative specimen collection methods such as string test (or Enterotest (R)), nasopharyngeal aspirates and stools samples, as alternatives to gastric aspirate
| Condition | Intervention |
|---|---|
|
HIV Tuberculosis Pediatric |
Other: Development of a diagnosis algorithm |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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) |
Resource links provided by NLM:
Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Primary Outcome Measures:
- Tuberculosis diagnosis assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Tubercolosis diagnosis assessement is based on the following exams results:
- Clinical examination
- Chest X-rays
- Addominal ultrasound
- IGRAs
- Gastric aspirate
- String test
- Nasopharyngeal aspirate
- Stools sample
- sputum
Secondary Outcome Measures:
- Evaluation of the QuantiFERON(R)-TB Gold In-Tube [ Time Frame: 6 months ] [ Designated as safety issue: No ]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
- Comparison of two in-vitro IGRAs [ Time Frame: 6 months ] [ Designated as safety issue: No ]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 chhildren.
- Percentage of TB diagnosis sampling procedures actually performed [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
To assess feasibility of the following TB diagnosis evaluated procedures:
- the string test
- the nasopharyngeal aspirate
- stools sample
- 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 ] [ Designated as safety issue: Yes ]
- Specificity and sensibility of TB diagnosis sampling procedures compared to TB diagnosis gold standard (sputum culture) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
To assess performance of the following TB diagnosis evaluated procedures:
- the string test
- the nasopharyngeal aspirate
- stools sample
| Estimated Enrollment: | 420 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Other: Development of a diagnosis algorithm
- interview on anamnesis
- clinical examination
evaluation of HIV infection stage
-Laboratory analysis:
- hematology and biochemistry tests
- CD4 cells count
- HIV viral load
Interferon Gamma Release Assay
-Radiology:
- chest radiograph
Abdominal ultrasonograph to detect abdominal lymphadenopathy
- Tuberculin skin test
- Bacteriological specimen collection:
- 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
At entry in the study, HIV infected children with suspected tuberculosis will undergo a complete evaluation including:
Diagnosis and treatment will be done according to national guidelines. The children will be followed-up for 6 months until the end of their anti-tuberculosis treatment.
Eligibility| Ages Eligible for Study: | up to 13 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Exclusion Criteria:
- history of anti TB treatment started in the past 2 years
- on going tuberculosis treatment
- Suspicion of exclusive extra-thoracic tuberculosis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331811
Contacts
| Contact: Olivier Marcy, MD | +855 92 734 025 | oliviermarcy@gmail.com |
| Contact: Laurance Borand, PharmD | +855 12 333 671 | lborand@pasteur-kh.org |
Locations
| Burkina Faso | |
| CHU Sourô Sanou | Not yet recruiting |
| Bobo Dioulasso, Burkina Faso | |
| Contact: Boubacar Nacro, MD +226 20 97 00 44 bnacro@fasonet.bf | |
| Cambodia | |
| National Pediatric Hospital | Recruiting |
| Phnom Penh, Cambodia | |
| Contact: Vibol Ung, MD +855 11 858 165 u_vibol@yahoo.com | |
| Angkor Hospital for Children | Not yet recruiting |
| Siem Reap, Cambodia | |
| Contact: Leakheana Neou +855 12 863 584 leakhena@angkorhospital.org | |
| Cameroon | |
| Centre Mère Enfant Chantal Biya | Not yet recruiting |
| Yaounde, Cameroon | |
| Contact: Francis Ataba, MD +237 77 33 00 55 atebfranc@yahoo.fr | |
| Vietnam | |
| Pediatric Hospital Nhi Dong 1 | Not yet recruiting |
| Ho Chi Minh City, Vietnam | |
| Contact: Khanh Truong Huu, MD +84 913 117 965 khanhnhiem@yahoo.com | |
| Pediatric Hospital Nhi Dong 2 | Not yet recruiting |
| Ho Chi Minh City, Vietnam | |
| Contact: Viet Do Chau +84 903 779 576 dochauviet@yahoo.com | |
| Pham Ngoc Thach Hospital | Not yet recruiting |
| Ho chi Minh ville, Vietnam | |
| Contact: Nguyen Thi Ngoc Lan, MD +84 903 829 817 ngoclan0456@yahoo.com | |
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Pasteur Institute in Cambodia
National Pediatric Hospital, Cambodia
Angkor Hospital for Children
Pham Ngoc Thach Hospital, Vietnam
Pediatric Hospital Nhi Dong 1, Ho Chi Minh City, Vietnam
Pediatric Hospital Nhi Dong 2, Ho Chi Minh City, Vietnam
Hôpital Necker-Enfants Malades
Groupe Hospitalier Pitie-Salpetriere
CHRU Arnaud de Villeveuve, Montpellier, France
IRD, Yaounde, Cameroon
Fondation Chantal Biya,Yaounde, Cameroon
CHU Sourô Sanou, Bobo Dioulasso, Burkina Faso
Investigators
| Study Chair: | Olivier Marcy, MD | Institut Pasteur in Cambodia, Phnom Penh, Cambodia |
| Study Chair: | Sophan Sam, MD | National Pediatric Hospital, Phnom Penh, Cambodia |
More Information
No publications provided
| Responsible Party: | French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) ( French National Agency for Research on AIDS and Viral Hepatitis ) |
| ClinicalTrials.gov Identifier: | NCT01331811 History of Changes |
| Other Study ID Numbers: | ANRS12229 PAANTHER 01 |
| Study First Received: | April 4, 2011 |
| Last Updated: | May 11, 2012 |
| Health Authority: | Cambodia: Ministry of Health Vietnam: Ho Chi Minh City Health Service Vietnam: Ministry of Health Burkina Faso: Ministry of Health Cameroon: Ministry of Health |
Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
|
HIV Tuberculosis Diagnosis |
Pediatry Asia Africa |
Additional relevant MeSH terms:
|
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 22, 2013