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

HIV Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331811
• Other study ID #: ANRS12229 PAANTHER 01
• Status: Completed
• Phase: N/A
• First received: April 4, 2011
• Last updated: August 4, 2015
• Start date: April 2011
• Est. completion date: May 2014

Study information

• Verified date: August 2015
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cambodia: Ministry of HealthVietnam: Ho Chi Minh City Health ServiceVietnam: Ministry of HealthBurkina Faso: Ministry of HealthCameroon: Ministry of Health
• Study type: Interventional

Clinical 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 13 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• HIV
• Pediatrics
• Tuberculosis

Intervention

Other:
• Development of a diagnosis algorithm
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.

Locations

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

Sponsors (16)

Lead Sponsor

Collaborator

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Angkor Hospital for Children, Centre Hospitalier D'essos, Centre Muraz, Centre Pasteur du Cameroun, Children's Hospital Number 2, Ho Chi Minh City, Vietnam, CHRU Arnaud de Villeveuve, Montpellier, France, CHU Sourô Sanou, Bobo Dioulasso, Burkina Faso, Fondation Chantal Biya,Yaounde, Cameroon, Groupe Hospitalier Pitie-Salpetriere, Hôpital Necker-Enfants Malades, Paris, France, Institut Pasteur, Cambodia, IRD, Yaounde, Cameroon, National Pediatric Hospital, Cambodia, Pediatric Hospital Nhi Dong 1, Ho Chi Minh City, Vietnam, Pham Ngoc Thach Hospital, Ho Chi Minh City, Vietnam

Countries where clinical trial is conducted

Burkina Faso,  Cambodia,  Cameroon,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	6 months	No
Secondary	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.	6 months	No
Secondary	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	6 months	Yes
Secondary	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	Yes
Secondary	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	6 months	Yes
Secondary	Evaluation of the Xpert MTB/RIF assay	Evaluate the sensitivity, specificity, positive and negative predictive values of the Xpert MTB/RIF assay	6 months	No
Secondary	Comparison of the Xpert MTB/RIF test to the gold standard (culture of gastric aspirates or sputum)		6 months	No
Secondary	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	6 months	No