Diagnosis of Active and Latent TB Infection With IFN-y Assays in African Children

Tuberculosis Clinical Trial

— ALTAC  

Official title:

Diagnosis of Active and Latent TB Infection With IFN-y Assays in African Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00456469
• Other study ID #: 06.49 TF Cuevas
• Status: Not yet recruiting
• Phase: N/A
• First received: April 4, 2007
• Last updated: April 4, 2007
• Start date: May 2007
• Est. completion date: October 2009

Study information

• Verified date: April 2007
• Source: Liverpool School of Tropical Medicine
• Contact: Luis Cuevas, MD MTropMed
• Phone: 0151 705 3219
• Email: lcuevas[@]liv.ac.uk
• Is FDA regulated: No
• Health authority: Ethiopia: Ethiopia Science and Technology CommissionUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial Summary

Study based in Southern Ethiopia Purpose - to explore if children in contact with adults with TB have positive acute reactants such as IFN-y and other cytokine responses; if these responses discriminate between high and low risk of disease progression and whether these could be incorporated into improved diagnostic approaches.

Description:

The study follows children in contact with TB. Those with positive TST will be offered chemoprophylaxis and all children will be followed for 2 years to describe IFN-y responses over time, identify symptoms of active TB and if these symptoms are associated with IFN-y and other cytokine responses.

Children with suspicion of TB attending health centres will also be investigated using routine diagnostic tests and IFN-y and other cytokines responses to evaluate if the latter could be used in improved diagnostic approaches.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 14 Years

Eligibility

Inclusion Criteria:

• Children - 1 to 14 years old in contact with adults with smear positive TB

Or:

• Children with suspicion of TB admitted to the hospital for investigations

Exclusion Criteria:

• Residency > 10 Km from recruitment center

Or:

• Patient severely to undergo diagnostic procedures.

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Tuberculosis

Locations

Country	Name	City	State
Ethiopia	Bushullo Major Health Centre	Awassa	Southern Region

Sponsors (2)

Lead Sponsor	Collaborator
Liverpool School of Tropical Medicine	Thrasher Research Fund

Country where clinical trial is conducted

Ethiopia,