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Alere Mycobacterium Tuberculosis Urine Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01585532
First Posted: April 26, 2012
Last Update Posted: November 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Alere Technologies GmbH
Information provided by (Responsible Party):
Research Center Borstel
  Purpose
Current molecular methods will be evaluated for the detection of Mycobacterium tuberculosis specific nucleic acid in urine and blood of patients.

Condition
Tuberculosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Various Methods for the Detection of Mycobacterium Tuberculosis Nucleic Acid

Resource links provided by NLM:


Further study details as provided by Research Center Borstel:

Primary Outcome Measures:
  • 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


Biospecimen Retention:   Samples Without DNA
Urine Sputum Blood

Enrollment: 60
Study Start Date: January 2012
Study Completion Date: December 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
TB suspects with alternative final diagnosis
Confirmed tuberculosis patients

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with suspected or confirmed tuberculosis
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01585532


Locations
Germany
Research Center Borstel
Borstel, Schleswig-Holstein, Germany, 23845
Sponsors and Collaborators
Research Center Borstel
Alere Technologies GmbH
  More Information

Responsible Party: Research Center Borstel
ClinicalTrials.gov Identifier: NCT01585532     History of Changes
Other Study ID Numbers: RCBorstel002
CLDG-0402 ( Other Identifier: Alere Technologies GmbH )
First Submitted: April 13, 2012
First Posted: April 26, 2012
Last Update Posted: November 5, 2015
Last Verified: November 2015

Keywords provided by Research Center Borstel:
Tuberculosis
Urine
Nucleic acid
Alere
Borstel

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections