Alere Mycobacterium Tuberculosis Urine Study

Completed

• Conditions: Tuberculosis

• Registration Number: NCT01585532
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-26
• Primary Completion: 2013-08
• Study Completion: 2013-12
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-03
• Last Update Posted: 2015-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity	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

Trial Locations

Locations (1)

Research Center Borstel; 🇩🇪 Borstel, Schleswig-Holstein, Germany