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Sponsors and Collaborators: |
Liverpool School of Tropical Medicine Thrasher Research Fund |
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Information provided by: | Liverpool School of Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT00456469 |
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 |
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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 |
Estimated Enrollment: | 500 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | October 2009 |
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.
Ages Eligible for Study: | 1 Year to 14 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Or:
Exclusion Criteria:
Or:
Contact: Luis Cuevas, MD MTropMed | 0151 705 3219 | lcuevas@liv.ac.uk |
Ethiopia, Southern Region | |
Bushullo Major Health Centre | |
Awassa, Southern Region, Ethiopia, 12 |
Principal Investigator: | Luis Cuevas, Dr | Liverpool School of Tropical Medicine |
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 |
TB latent infection Ethiopia |
Bacterial Infections Gram-Positive Bacterial Infections Mycobacterium Infections Tuberculosis |
Bacterial Infections Gram-Positive Bacterial Infections Mycobacterium Infections |
Tuberculosis Infection Actinomycetales Infections |