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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Collaborators:
Information provided by:

Study Description
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.


Condition or disease
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 Design

Study Type : Observational
Estimated Enrollment : 250 participants
Time Perspective: Prospective
Official Title: Evaluation of Urine Lipoarabinomannan ELISA In Diagnostics of Childhood Tuberculosis
Study Start Date : August 2007
Estimated Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Study Population
Children up to 14 years of age with suspicion of TB
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no informed consent
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Norbert Heinrich, MD 0049 179 7044231 norbert.heinrich@ukb.uni-bonn.de
Contact: John Chimphamba, Clinical Officer 00265 9394287

Locations
Malawi
Our Lady of Mount Carmel Hospital Recruiting
Kapiri/Mchinji, Mchinji, Malawi
Principal Investigator: John Chimphamba, Clinical Officer         
Sponsors and Collaborators
University Hospital, Bonn
Our Lady of Mount Carmel Community Hospital, Kapiri, Malawi
Ministry of Health and Population, Malawi
Mbeya Medical Research Programme, Mbeya, Tanzania
Unterstützerkreis Missionskrankenhaus Kapiri e.V., Munich, Germany
Foerderverein AIDS im Kindesalter in Bonn e.V., Bonn, Germany
Children`s Medical Hospital, University of 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
More Information

Responsible Party: Dr. Norbert Heinrich, Principal Investigator, Department of Tropical Medicine, Ludwig-Maximilan-University, Munich, Germany
ClinicalTrials.gov Identifier: NCT00512330     History of Changes
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

Keywords provided by University Hospital, Bonn:
childhood
tuberculosis
diagnostic
lipoarabinomannan
ELISA
Tuberculosis in Childhood

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections