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

April 4, 2007 updated by: Liverpool School of Tropical Medicine
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Luis Cuevas, MD MTropMed
  • Phone Number: 0151 705 3219
  • Email: lcuevas@liv.ac.uk

Study Locations

  • Ethiopia
    • Southern Region
      • Awassa, Southern Region, Ethiopia, 12
        • Bushullo Major Health Centre
        • Contact:
          • Mohammed Yassin, Dr
        • Sub-Investigator:
          • Mohammed Yassin, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liverpool School of Tropical Medicine

Collaborators

Thrasher Research Fund

Investigators

  • Principal Investigator: Luis Cuevas, Dr, Liverpool School of Tropical Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Study Completion (Anticipated)

October 1, 2009

Study Registration Dates

First Submitted

April 4, 2007

First Submitted That Met QC Criteria

April 4, 2007

First Posted (Estimate)

April 5, 2007

Study Record Updates

Last Update Posted (Estimate)

April 5, 2007

Last Update Submitted That Met QC Criteria

April 4, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06.49 TF Cuevas

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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