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Technical Evaluation of Brahms PCT Direct

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01771029
First Posted: January 18, 2013
Last Update Posted: December 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Thermo Fisher Scientific
Information provided by (Responsible Party):
Philipp Schuetz, University Hospital, Basel, Switzerland
  Purpose
Validation of the technical performance of the BRAHMS PTC direct point-of-care assay under routine conditions with native patient samples. The clinical validation is planned as a method comparison to a reference method (BRAHMS PCT sensitive KRYPTOR, Elecsys BRAHMS PCT). The study hypothesis is to show a highest correlation between the new product and the reference methods.

Condition
Infection

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Technical Evaluation of a Whole Blood Rapid Test Measuring Procalcitonin (BRAHMS PCT Direct)

Further study details as provided by Philipp Schuetz, University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Correlation between BRAHMS PCT direct and reference method. [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
    Showing at least 90% correlation between BRAHMS PCT direct with the PCT reference method for PCT- positive and negative samples.


Secondary Outcome Measures:
  • Time to result [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
    The secondary object of this study is to show the advantage of BRAHMS PCT direct in time to result in comparison to the reference method.


Enrollment: 150
Study Start Date: February 2013
Study Completion Date: September 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Procalcitonin (PCT) is a highly sensitive and specific marker which can be detected in the blood stream in response to a bacterial infection. In contrast to conventional infection disease markers PCT permits the differential diagnosis between bacterial and viral infections. The marker is implemented on Intensive Care Units (ICU) and Emergency Departments (ED) worldwide since 1996. Until now various technologies all basing on the use of serum or plasma samples are available in the market.

BRAHMS GmbH (Clinical Diagnostics Division of Thermo Fisher Scientific) as manufacturer of the Procalcitonin assays has developed a new quantitative immunochromatographic whole blood point-of-care assay, the BRAHMS PCT direct. The test follows the principle of a sandwich assay with two anti-PCT antibodies, one immobilized on a nitrocellulose membrane and the tracer antibodies labeled with gold.

Validation of the technical performance of the product under routine conditions with native patient samples. The clinical validation is planned as a method comparison to a reference method (BRAHMS PCT sensitive KRYPTOR, Elecsys BRAHMS PCT). The internal pre-studies were performed with blood samples spiked with recombinant PCT and with native patient samples.

The primary objective of this study is to show a highest correlation between BRAHMS PCT direct with the PCT reference method for PCT- positive and negative samples.

The secondary object of this study is to show the advantage of BRAHMS PCT direct in time to result in comparison to the reference method.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
One cohort of 150-250 patients, possible infection at initial presentation in Kantonsspital Aarau.
Criteria

Inclusion Criteria:

  • Age > 18 years
  • possible infection at initial presentation
  • informed consent

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771029


Locations
France
Pitié Salpetrière. Groupement hospitalière universitaire Est
Paris, France, 7565
Germany
Klinikum Ernst von Bergmann, gemeinnützige GmbH Akademisches Lehrkrankenhaus der Humboldt-Universität Berlin (Charité)
Potsdam, Germany, 14467
Switzerland
Kantonsspital Aarau Innere Medizin
Aarau, Aargau, Switzerland, 5001
Sponsors and Collaborators
Philipp Schuetz
Thermo Fisher Scientific
Investigators
Principal Investigator: Philipp Schuetz, PD, Dr.med. Kantonsspital Aarau
  More Information

Responsible Party: Philipp Schuetz, PD Dr. med. Oberarzt, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01771029     History of Changes
Other Study ID Numbers: POC_1
First Submitted: January 9, 2013
First Posted: January 18, 2013
Last Update Posted: December 12, 2014
Last Verified: December 2014

Keywords provided by Philipp Schuetz, University Hospital, Basel, Switzerland:
Procalcitonin
Infection
Point-of-Care

Additional relevant MeSH terms:
Calcitonin
Bone Density Conservation Agents
Physiological Effects of Drugs