NCT01771029

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2013

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 12, 2014

Status Verified

December 1, 2014

Enrollment Period

1.3 years

First QC Date

January 9, 2013

Last Update Submit

December 11, 2014

Conditions

Infection

Keywords

ProcalcitoninInfectionPoint-of-Care

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Time to result

    participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

One cohort of 150-250 patients, possible infection at initial presentation in Kantonsspital Aarau.

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pitié Salpetrière. Groupement hospitalière universitaire Est

Paris, Paris, 7565, France

Location

Klinikum Ernst von Bergmann, gemeinnützige GmbH Akademisches Lehrkrankenhaus der Humboldt-Universität Berlin (Charité)

Potsdam, 14467, Germany

Location

Kantonsspital Aarau Innere Medizin

Aarau, Canton of Aargau, 5001, Switzerland

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Philipp Schuetz, PD, Dr.med.

    Kantonsspital Aarau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PD Dr. med. Oberarzt

Study Record Dates

First Submitted

January 9, 2013

First Posted

January 18, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2014

Study Completion

September 1, 2014

Last Updated

December 12, 2014

Record last verified: 2014-12

Locations

DE(1)CH(1)FR(1)