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

Evaluation of Urine Lipoarabinomannan ELISA In Diagnostics of Childhood Tuberculosis

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.

Study Overview

• Status: Unknown
• Conditions: Tuberculosis

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 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
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• Malawi
  • Mchinji
    • Kapiri/Mchinji, Mchinji, Malawi
      • Recruiting
      • Our Lady of Mount Carmel Hospital
      • Principal Investigator: John Chimphamba, Clinical Officer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Study Population

Children up to 14 years of age with suspicion of TB

Description

Inclusion Criteria:

• age 0-14 years
• suspicion of active TB or TB contact

Exclusion Criteria:

• no informed consent

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Study Completion (Anticipated): August 1, 2008

Study Registration Dates

• First Submitted: August 6, 2007
• First Submitted That Met QC Criteria: August 6, 2007
• First Posted (Estimate): August 7, 2007

Study Record Updates

• Last Update Posted (Estimate): August 6, 2008
• Last Update Submitted That Met QC Criteria: August 5, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: tuberculosis; diagnostic; childhood; ELISA; lipoarabinomannan; Tuberculosis in Childhood
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: LAM ELISA in childhood TB