Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512330
Status:
UNKNOWN
Last Update Posted:
2008-08-06
First Post:
2007-08-06
Brief Title:
Lipoarabinomannan LAM Enzyme-Linked Immunosorbent Assay ELISA in Diagnostics of Childhood Tuberculosis TB
Sponsor:
University Hospital Bonn
Organization:
University Hospital Bonn
Study Overview
Official Title:
Evaluation of Urine Lipoarabinomannan ELISA In Diagnostics of Childhood Tuberculosis
Status:
UNKNOWN
Status Verified Date:
2008-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Our study aims to evaluate this test in the diagnosis of children with TB
Detailed Description:
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 803 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 patients urine will be done
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 patients urine will be done
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None