Alere Mycobacterium Tuberculosis Urine Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Center Borstel

Borstel, Schleswig-Holstein, 23845, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Sensitivity and specificity

Time frame: 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

Sponsors and collaborators

Lead sponsor

Research Center Borstel

Other

Collaborators

Alere Technologies GmbH

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Apr 26, 2012
Registry last updated: Nov 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed