Alere Mycobacterium Tuberculosis Urine Study

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. Identifier: NCT01585532
Recruitment Status : Completed
First Posted : April 26, 2012
Last Update Posted : November 5, 2015
Alere Technologies GmbH
Information provided by (Responsible Party):
Research Center Borstel

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

Condition or disease

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Various Methods for the Detection of Mycobacterium Tuberculosis Nucleic Acid
Study Start Date : January 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : December 2013

TB suspects with alternative final diagnosis
Confirmed tuberculosis patients

Primary Outcome Measures :
  1. 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

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

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

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 identifier (NCT number): NCT01585532

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

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

Keywords provided by Research Center Borstel:
Nucleic acid

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