MedDataX Logo

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

NCT ID: NCT00512330

Last Updated: 2008-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tuberculosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

childhood tuberculosis diagnostic lipoarabinomannan ELISA Tuberculosis in Childhood

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* no informed consent
Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Our Lady of Mount Carmel Community Hospital, Kapiri, Malawi

UNKNOWN

Sponsor Role collaborator

Ministry of Health and Population, Malawi

OTHER_GOV

Sponsor Role collaborator

Mbeya Medical Research Programme, Mbeya, Tanzania

UNKNOWN

Sponsor Role collaborator

Unterstützerkreis Missionskrankenhaus Kapiri e.V., Munich, Germany

UNKNOWN

Sponsor Role collaborator

Foerderverein AIDS im Kindesalter in Bonn e.V., Bonn, Germany

UNKNOWN

Sponsor Role collaborator

Children's Medical Hospital, University of Bonn, Germany

OTHER

Sponsor Role collaborator

University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Department of Tropical Medicine, Ludwig-Maximilan-University, Munich, Germany

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Norbert Heinrich, MD

Role: STUDY_CHAIR

University of Bonn

John Chimphamba, Clinical Officer

Role: PRINCIPAL_INVESTIGATOR

Our Lady of Mount Carmel Hospital, Kapiri

Andreas Mueller, PD Dr med.

Role: STUDY_CHAIR

University of Bonn

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Our Lady of Mount Carmel Hospital

Kapiri/Mchinji, Mchinji, Malawi

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Malawi

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Norbert Heinrich, MD

Role: CONTACT

Phone: 0049 179 7044231

Email: [email protected]

John Chimphamba, Clinical Officer

Role: CONTACT

Phone: 00265 9394287

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LAM ELISA in childhood TB

Identifier Type: -

Identifier Source: org_study_id