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

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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:
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

Tracking Information
First Submitted Date August 6, 2007
First Posted Date August 7, 2007
Last Update Posted Date August 6, 2008
Study Start Date August 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Lipoarabinomannan (LAM) Enzyme-Linked Immunosorbent Assay (ELISA) in Diagnostics of Childhood Tuberculosis (TB)
Official Title Evaluation of Urine Lipoarabinomannan ELISA In Diagnostics of Childhood Tuberculosis
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.

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
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Children up to 14 years of age with suspicion of TB
Condition Tuberculosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 5, 2008)
250
Original Estimated Enrollment
 (submitted: August 6, 2007)
81007
Estimated Study Completion Date August 2008
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages up to 14 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Malawi
Removed Location Countries  
 
Administrative Information
NCT Number NCT00512330
Other Study ID Numbers LAM ELISA in childhood TB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Norbert Heinrich, Principal Investigator, Department of Tropical Medicine, Ludwig-Maximilan-University, Munich, Germany
Study Sponsor University Hospital, Bonn
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
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
PRS Account University Hospital, Bonn
Verification Date August 2008