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

August 5, 2008 updated by: University Hospital, Bonn

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAM ELISA in childhood TB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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