Lipoarabinomannan (LAM) Enzyme-Linked Immunosorbent Assay... | NCT00512330

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

NCT00512330

Sponsor

University Hospital, Bonn

Status

Unknown status

Last Update Posted

Aug 6, 2008Estimated

Enrollment

250Estimated

Phase

Not provided

Conditions

Tuberculosis

Interventions

Not provided

Countries

Malawi

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Not provided

Completion Date

Aug 2008Estimated

First Submitted Date

Aug 6, 2007

First Submission Date that Met QC Criteria

Aug 6, 2007

First Posted Date

Aug 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2008

Last Update Posted Date

Aug 6, 2008Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University Hospital, BonnOTHER

Collaborators

Name	Class
Our Lady of Mount Carmel Community Hospital, Kapiri, Malawi	UNKNOWN
Ministry of Health, Malawi	OTHER_GOV
Mbeya Medical Research Programme, Mbeya, Tanzania	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

no informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

14 Years

Standard Ages

Child

Study Population

Children up to 14 years of age with suspicion of TB

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Norbert Heinrich, MD	Contact	0049 179 7044231		norbert.heinrich@ukb.uni-bonn.de
John Chimphamba, Clinical Officer	Contact	00265 9394287

Overall Officials

Name	Affiliation	Role
Norbert Heinrich, MD	University of Bonn	Study Chair
John Chimphamba, Clinical Officer	Our Lady of Mount Carmel Hospital, Kapiri	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Our Lady of Mount Carmel Hospital	Recruiting	Kapiri/Mchinji	Mchinji		Malawi

Condition Browse Module

MeSH Terms

ID	Term
D014376	Tuberculosis
D004194	Disease

Ancestor Terms

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

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