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Tracking Information | |||||
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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. |
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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. |
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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. |
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Recruitment Information | |||||
Recruitment Status † | Not yet recruiting | ||||
Enrollment † | 500 | ||||
Estimated Completion Date | October 2009 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Or:
Exclusion Criteria:
Or:
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Gender | Both | ||||
Ages | 1 Year to 14 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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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 † |
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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. |