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| Sponsors and Collaborators: |
University Hospital, Bonn Our Lady of Mount Carmel Community Hospital, Kapiri, Malawi Ministry of Health and Population, Malawi Mbeya Medical Research Programme, Mbeya, Tanzania Unterstützerkreis Missionskrankenhaus Kapiri e.V., Munich, Germany Foerderverein AIDS im Kindesalter in Bonn e.V., Bonn, Germany Children`s Medical Hospital, University of Bonn, Germany |
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| Information provided by: | University Hospital, Bonn |
| ClinicalTrials.gov Identifier: | NCT00512330 |
Purpose
In children, it remains quite difficult even in developed countries, to prove a diagnosis of Tuberculosis (TB). New means for diagnosis of this disease are currently being researched. One candidate test is Lipoarabinomannan ELISA from Urine, which has shown good sensitivity of up to 80% in adults.
Our study aims to evaluate this test in the diagnosis of children with TB.
| Condition |
|---|
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Tuberculosis |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | Evaluation of Urine Lipoarabinomannan ELISA In Diagnostics of Childhood Tuberculosis |
| Estimated Enrollment: | 250 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | August 2008 |
Among candidate new diagnostics for TB, a test for mycobacterial Lipoarabinomannan (LAM) excretion in urine has shown promising results in one Tanzanian study: The sensitivity for detecting TB culture-positive patients was 80.3%. Of 103 healthy volunteers, only one gave a false positive result (Boehme, 2005).
Until now, there are only data concerning this test for diagnosis of adult disease. For evaluation of routine use in children in countries like Malawi, we are starting a prospective study. Children 0-14 years of age with suspected TB will be investigated using TB culture as the gold standard. In sputum samples, microscopy will be done. Simultaneously, LAM Elisa from the patient´s urine will be done.
Eligibility| Ages Eligible for Study: | up to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Children up to 14 years of age with suspicion of TB
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Norbert Heinrich, MD | 0049 179 7044231 | norbert.heinrich@ukb.uni-bonn.de |
| Contact: John Chimphamba, Clinical Officer | 00265 9394287 |
| Malawi, Mchinji | |
| Our Lady of Mount Carmel Hospital | Recruiting |
| Kapiri/Mchinji, Mchinji, Malawi | |
| Principal Investigator: John Chimphamba, Clinical Officer | |
| Study Chair: | Norbert Heinrich, MD | University Hospital, Bonn |
| Principal Investigator: | John Chimphamba, Clinical Officer | Our Lady of Mount Carmel Hospital, Kapiri |
| Study Chair: | Andreas Mueller, PD Dr med. | University Hospital, Bonn |
More Information
| Responsible Party: | Department of Tropical Medicine, Ludwig-Maximilan-University, Munich, Germany ( Dr. Norbert Heinrich, Principal Investigator ) |
| Study ID Numbers: | LAM ELISA in childhood TB |
| Study First Received: | August 6, 2007 |
| Last Updated: | August 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00512330 |
| Health Authority: | Malawi: National Health Sciences Research Committee |
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childhood tuberculosis diagnostic |
lipoarabinomannan ELISA Tuberculosis in Childhood |
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Bacterial Infections Gram-Positive Bacterial Infections Mycobacterium Infections Tuberculosis |
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Actinomycetales Infections |
