Lipoarabinomannan (LAM) Enzyme-Linked Immunosorbent Assay (ELISA) in Diagnostics of Childhood Tuberculosis (TB)
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|ClinicalTrials.gov Identifier: NCT00512330|
Recruitment Status : Unknown
Verified August 2008 by University Hospital, Bonn.
Recruitment status was: Recruiting
First Posted : August 7, 2007
Last Update Posted : August 6, 2008
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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 or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Evaluation of Urine Lipoarabinomannan ELISA In Diagnostics of Childhood Tuberculosis|
|Study Start Date :||August 2007|
|Estimated Study Completion Date :||August 2008|
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|Ages Eligible for Study:||up to 14 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- age 0-14 years
- suspicion of active TB or TB contact
- no informed consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512330
|Contact: Norbert Heinrich, MD||0049 179 firstname.lastname@example.org|
|Contact: John Chimphamba, Clinical Officer||00265 9394287|
|Our Lady of Mount Carmel Hospital||Recruiting|
|Kapiri/Mchinji, Mchinji, Malawi|
|Principal Investigator: John Chimphamba, Clinical Officer|
|Study Chair:||Norbert Heinrich, MD||University of Bonn|
|Principal Investigator:||John Chimphamba, Clinical Officer||Our Lady of Mount Carmel Hospital, Kapiri|
|Study Chair:||Andreas Mueller, PD Dr med.||University of Bonn|
|Responsible Party:||Dr. Norbert Heinrich, Principal Investigator, Department of Tropical Medicine, Ludwig-Maximilan-University, Munich, Germany|
|Other Study ID Numbers:||
LAM ELISA in childhood TB
|First Posted:||August 7, 2007 Key Record Dates|
|Last Update Posted:||August 6, 2008|
|Last Verified:||August 2008|
Tuberculosis in Childhood
Gram-Positive Bacterial Infections
Bacterial Infections and Mycoses