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

Not Applicable

Completed

• Conditions: HIV; Pediatrics; Tuberculosis

• Registration Number: NCT01331811
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-08
• Primary Completion: 2014-03
• Study Completion: 2014-05
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-04
• Last Update Posted: 2015-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 441

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Tuberculosis diagnostic algorithm	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

Secondary Outcome Measures

Name	Time	Method
Evaluation of the QuantiFERON(R)-TB Gold In-Tube	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
Comparison of two in-vitro IGRAs	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.
Percentage of TB diagnosis sampling procedures actually performed	6 months	To assess the feasibility of the following TB sampling procedures: * the string test; * the nasopharyngeal aspirate; * stool sample
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	To assess the performance of the following TB sampling procedures: * the string test; * the nasopharyngeal aspirate; * stools sample
Evaluation of the Xpert MTB/RIF assay	6 months	Evaluate the sensitivity, specificity, positive and negative predictive values of the Xpert MTB/RIF assay
Comparison of the Xpert MTB/RIF test to the gold standard (culture of gastric aspirates or sputum)	6 months
Comparison of the performance Xpert MTB/RIF assay on sampling methods other than the reference method (gastric aspirate and sputum)	6 months	Evaluation of the Xpert MTB/RIF assay on the following sampling methods: * String test; * Nasopharyngeal aspirates; * Stool samples

Trial Locations

Locations (8)

CHU Sourô Sanou; 🇧🇫 Bobo Dioulasso, Burkina Faso

National Pediatric Hospital; 🇰🇭 Phnom Penh, Cambodia

Centre Hospitalier d'Essos; 🇨🇲 Yaounde, Cameroon

Centre Mère Enfant Chantal Biya; 🇨🇲 Yaounde, Cameroon

Angkor Hospital for Children; 🇰🇭 Siem Reap, Cambodia

Pediatric Hospital Nhi Dong 2; 🇻🇳 Ho Chi Minh City, Vietnam

Pediatric Hospital Nhi Dong 1; 🇻🇳 Ho Chi Minh City, Vietnam

Pham Ngoc Thach Hospital; 🇻🇳 Ho chi Minh ville, Vietnam