Lipoarabinomannan (LAM) Enzyme-Linked Immunosorbent Assay (ELISA) in Diagnostics of Childhood Tuberculosis (TB)

Tuberculosis Clinical Trial

Official title:

Evaluation of Urine Lipoarabinomannan ELISA In Diagnostics of Childhood Tuberculosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00512330
• Other study ID #: LAM ELISA in childhood TB
• Status: Recruiting
• Phase: N/A
• First received: August 6, 2007
• Last updated: August 5, 2008
• Start date: August 2007
• Est. completion date: August 2008

Study information

• Verified date: August 2008
• Source: University Hospital, Bonn
• Contact: Norbert Heinrich, MD
• Phone: 0049 179 7044231
• Email: norbert.heinrich[@]ukb.uni-bonn.de
• Is FDA regulated: No
• Health authority: Malawi: National Health Sciences Research Committee
• Study type: Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 14 Years

Eligibility

Inclusion Criteria:

• age 0-14 years

• suspicion of active TB or TB contact

Exclusion Criteria:

• no informed consent

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Tuberculosis

Locations

Country	Name	City	State
Malawi	Our Lady of Mount Carmel Hospital	Kapiri/Mchinji	Mchinji

Sponsors (7)

Lead Sponsor	Collaborator
University Hospital, Bonn	Children`s Medical Hospital, University of Bonn, Germany, Foerderverein AIDS im Kindesalter in Bonn e.V., Bonn, Germany, Mbeya Medical Research Programme, Mbeya, Tanzania, Ministry of Health and Population, Malawi, Our Lady of Mount Carmel Community Hospital, Kapiri, Malawi, Unterstützerkreis Missionskrankenhaus Kapiri e.V., Munich, Germany

Country where clinical trial is conducted

Malawi,