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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

April 4, 2007

Last Updated Date

April 4, 2007

Start Date ^†

May 2007

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

Brief 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.

Detailed 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.

Study Phase

Study Type ^†

Observational

Study Design ^†

Natural History, Longitudinal, Defined Population, Prospective Study

Condition ^†

Tuberculosis

Intervention ^†

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Not yet recruiting

Enrollment ^†

500

Estimated Completion Date

October 2009

Primary Completion Date

Eligibility Criteria ^†

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.

Gender

Both

Ages

1 Year to 14 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Luis Cuevas, MD MTropMed

0151 705 3219

lcuevas@liv.ac.uk

Location Countries ^†

Ethiopia

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00456469

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Liverpool School of Tropical Medicine

Collaborators ^††

Thrasher Research Fund

Investigators ^†

Principal Investigator:

Luis Cuevas, Dr

Liverpool School of Tropical Medicine

Information Provided By

Liverpool School of Tropical Medicine

Verification Date

April 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.