Alere Mycobacterium Tuberculosis Urine Study

Evaluation of Various Methods for the Detection of Mycobacterium Tuberculosis Nucleic Acid

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01585532

Enrollment

Registered

2012-04-26

Start date

2012-01-31

Completion date

2013-12-31

Last updated

2015-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Keywords

Tuberculosis, Urine, Nucleic acid, Alere, Borstel

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Germany

Outcome results