Alere Mycobacterium Tuberculosis Urine Study

November 3, 2015 updated by: Research Center Borstel

Evaluation of Various Methods for the Detection of Mycobacterium Tuberculosis Nucleic Acid

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Borstel, Schleswig-Holstein, Germany, 23845
        • Research Center Borstel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with suspected or confirmed tuberculosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
TB suspects with alternative final diagnosis
Confirmed tuberculosis patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity
Time Frame: On admission to hospital
ROC analysis to determine the best specificity and sensitivity to differentiate between patients with tuberculosis and patients with an alternative diagnosis
On admission to hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Center Borstel

Collaborators

Alere Technologies GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

April 13, 2012

First Submitted That Met QC Criteria

April 23, 2012

First Posted (Estimate)

April 26, 2012

Study Record Updates

Last Update Posted (Estimate)

November 5, 2015

Last Update Submitted That Met QC Criteria

November 3, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCBorstel002
  • CLDG-0402 (Other Identifier: Alere Technologies GmbH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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