Technical Evaluation of Brahms PCT Direct

Infection Clinical Trial

Official title:

Technical Evaluation of a Whole Blood Rapid Test Measuring Procalcitonin (BRAHMS PCT Direct)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771029
• Other study ID #: POC_1
• Status: Completed
• Phase: N/A
• First received: January 9, 2013
• Last updated: December 11, 2014
• Start date: February 2013
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkomission
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• possible infection at initial presentation

• informed consent

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection

Locations

Country	Name	City	State
France	Pitié Salpetrière. Groupement hospitalière universitaire Est	Paris
Germany	Klinikum Ernst von Bergmann, gemeinnützige GmbH Akademisches Lehrkrankenhaus der Humboldt-Universität Berlin (Charité)	Potsdam
Switzerland	Kantonsspital Aarau Innere Medizin	Aarau	Aargau

Sponsors (2)

Lead Sponsor	Collaborator
Philipp Schuetz	Thermo Fisher Scientific

Countries where clinical trial is conducted

France,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between BRAHMS PCT direct and reference method.	Showing at least 90% correlation between BRAHMS PCT direct with the PCT reference method for PCT- positive and negative samples.	participants will be followed for the duration of hospital stay, an expected average of 2 weeks	No
Secondary	Time to result	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.	participants will be followed for the duration of hospital stay, an expected average of 2 weeks	No