Alere Mycobacterium Tuberculosis Urine Study

This study is currently recruiting participants. (see Contacts and Locations)
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
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 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
Bacterial Infections
Gram-Positive Bacterial Infections

ClinicalTrials.gov processed this record on October 22, 2014