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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by University Hospital, Bonn.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
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
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00512330
First received: August 6, 2007
Last updated: August 5, 2008
Last verified: August 2008
  Purpose

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
Tuberculosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Urine Lipoarabinomannan ELISA In Diagnostics of Childhood Tuberculosis

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Estimated Enrollment: 250
Study Start Date: August 2007
Estimated Study Completion Date: August 2008
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.

  Eligibility

Ages Eligible for Study:   up to 14 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 6, 2007
Last Updated: August 5, 2008
Health Authority: Malawi: National Health Sciences Research Committee

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

ClinicalTrials.gov processed this record on September 16, 2014