Alere Mycobacterium Tuberculosis Urine Study

This study is currently recruiting participants.
Verified December 2012 by Research Center Borstel
Sponsor:
Collaborator:
Alere Technologies GmbH
Information provided by (Responsible Party):
Research Center Borstel
ClinicalTrials.gov Identifier:
NCT01585532
First received: April 13, 2012
Last updated: December 7, 2012
Last verified: December 2012
  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 ] [ 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


Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated 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

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01585532

Contacts
Contact: Christian Herzmann, MD +49-4537-188-0 ext 6360 cherzmann@fz-borstel.de
Contact: Andrea Glaewe, SN +49-4537-188-0 ext 6360 aglaewe@fz-borstel.de

Locations
Germany
Research Center Borstel Recruiting
Borstel, Schleswig-Holstein, Germany, 23845
Contact: Christian Herzmann, MD    +49-4537-188-0 ext 6360    cherzmann@fz-borstel.de   
Contact: Andrea Glaewe, SN    +49-4537-188-0 ext 6360    aglaewe@fz-borstel.de   
Sub-Investigator: Christian Herzmann, MD         
Principal Investigator: Christoph Lange, Professor         
Sponsors and Collaborators
Research Center Borstel
Alere Technologies GmbH
  More Information

No publications provided

Responsible Party: Research Center Borstel
ClinicalTrials.gov Identifier: NCT01585532     History of Changes
Other Study ID Numbers: RCBorstel002, CLDG-0402
Study First Received: April 13, 2012
Last Updated: December 7, 2012
Health Authority: Germany: Ministry of Health

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

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

ClinicalTrials.gov processed this record on April 17, 2014