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Diagnosis of Active and Latent TB Infection With IFN-y Assays in African Children (ALTAC)
This study is not yet open for participant recruitment.
Verified by Liverpool School of Tropical Medicine, April 2007
First Received: April 4, 2007   No Changes Posted
Sponsors and Collaborators: Liverpool School of Tropical Medicine
Thrasher Research Fund
Information provided by: Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier: NCT00456469
  Purpose

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.


Condition
Tuberculosis

Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Official Title: Diagnosis of Active and Latent TB Infection With IFN-y Assays in African Children

Resource links provided by NLM:


Further study details as provided by Liverpool School of Tropical Medicine:

Estimated Enrollment: 500
Study Start Date: May 2007
Estimated Study Completion Date: October 2009
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.

  Eligibility

Ages Eligible for Study:   1 Year to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456469

Contacts
Contact: Luis Cuevas, MD MTropMed 0151 705 3219 lcuevas@liv.ac.uk

Locations
Ethiopia, Southern Region
Bushullo Major Health Centre
Awassa, Southern Region, Ethiopia, 12
Sponsors and Collaborators
Liverpool School of Tropical Medicine
Thrasher Research Fund
Investigators
Principal Investigator: Luis Cuevas, Dr Liverpool School of Tropical Medicine
  More Information

No publications provided

Study ID Numbers: 06.49 TF Cuevas
Study First Received: April 4, 2007
Last Updated: April 4, 2007
ClinicalTrials.gov Identifier: NCT00456469     History of Changes
Health Authority: Ethiopia: Ethiopia Science and Technology Commission;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Liverpool School of Tropical Medicine:
TB
latent
infection
Ethiopia

Study placed in the following topic categories:
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Tuberculosis

Additional relevant MeSH terms:
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Tuberculosis
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on September 02, 2009