Alere Mycobacterium Tuberculosis Urine Study

This study has been completed.
Alere Technologies GmbH
Information provided by (Responsible Party):
Research Center Borstel Identifier:
First received: April 13, 2012
Last updated: November 3, 2015
Last verified: November 2015
Current molecular methods will be evaluated for the detection of Mycobacterium tuberculosis specific nucleic acid in urine and blood of patients.


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 ] [ Designated as safety issue: No ]
    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)
TB suspects with alternative final diagnosis
Confirmed tuberculosis patients


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01585532

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

No publications provided

Responsible Party: Research Center Borstel Identifier: NCT01585532     History of Changes
Other Study ID Numbers: RCBorstel002  CLDG-0402 
Study First Received: April 13, 2012
Last Updated: November 3, 2015
Health Authority: Germany: Ministry of Health

Keywords provided by Research Center Borstel:
Nucleic acid

Additional relevant MeSH terms:
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections processed this record on February 08, 2016