Alere Mycobacterium Tuberculosis Urine Study

NCT ID: NCT01585532

Last Updated: 2015-11-05

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

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-12-31

Brief Summary

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Current molecular methods will be evaluated for the detection of Mycobacterium tuberculosis specific nucleic acid in urine and blood of patients.

Detailed Description

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Conditions

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Tuberculosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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TB suspects with alternative final diagnosis

No interventions assigned to this group

Confirmed tuberculosis patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Suspected or confirmed tuberculosis
* Age \>18 years
* informed consent obtained

Exclusion Criteria

* Previous participation in the study
* Simultaneous participation in a clinical trial investigating a new drug
* Inability to give consent
* Member of a vulnerable study population
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alere Technologies GmbH

INDUSTRY

Sponsor Role collaborator

Research Center Borstel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Center Borstel

Borstel, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

Other Identifiers

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CLDG-0402

Identifier Type: OTHER

Identifier Source: secondary_id

RCBorstel002

Identifier Type: -

Identifier Source: org_study_id

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