Technical Evaluation of Brahms PCT Direct

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by University Hospital, Basel, Switzerland
Sponsor:
Collaborator:
Thermo Fisher Scientific
Information provided by (Responsible Party):
Philipp Schuetz, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01771029
First received: January 9, 2013
Last updated: January 15, 2013
Last verified: January 2013
  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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 150
Study Start Date: February 2013
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • none
  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: NCT01771029

Contacts
Contact: Philipp Schuetz, PD Dr. med. 0041628389524 philipp.schuetz@ksa.ch

Locations
France
Pitié Salpetrière. Groupement hospitalière universitaire Est Not yet recruiting
Paris, France, 7565
Contact: Pierre Hausfater, Prof.         
Germany
Klinikum Ernst von Bergmann, gemeinnützige GmbH Akademisches Lehrkrankenhaus der Humboldt-Universität Berlin (Charité) Not yet recruiting
Potsdam, Germany, 14467
Contact: Michael Oppert, Dr.med.         
Switzerland
Kantonsspital Aarau Innere Medizin Not yet recruiting
Aarau, Aargau, Switzerland, 5001
Principal Investigator: Philipp Schuetz, PD Dr. med.         
Sponsors and Collaborators
Philipp Schuetz
Thermo Fisher Scientific
Investigators
Principal Investigator: Philipp Schuetz, PD, Dr.med. Kantonsspital Aarau
  More Information

No publications provided

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
Study First Received: January 9, 2013
Last Updated: January 15, 2013
Health Authority: Switzerland: Ethikkomission

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

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on September 22, 2014