Diagnosis of Active and Latent TB Infection With IFN-y Assays in African Children (ALTAC)
Recruitment status was Not yet recruiting
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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: | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective |
| 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.
Eligibility| Ages Eligible for Study: | 1 Year to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Luis Cuevas, MD MTropMed | 0151 705 3219 | lcuevas@liv.ac.uk |
| Ethiopia | |
| Bushullo Major Health Centre | Not yet recruiting |
| Awassa, Southern Region, Ethiopia, 12 | |
| Contact: Mohammed Yassin, Dr | |
| Sub-Investigator: Mohammed Yassin, Dr | |
| Principal Investigator: | Luis Cuevas, Dr | Liverpool School of Tropical Medicine |
More Information
No publications provided by Liverpool School of Tropical Medicine
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00456469 History of Changes |
| Other Study ID Numbers: | 06.49 TF Cuevas |
| Study First Received: | April 4, 2007 |
| Last Updated: | April 4, 2007 |
| 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 |
Additional relevant MeSH terms:
|
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 16, 2013