InfectionNCT01771029
Technical Evaluation of Brahms PCT Direct
An observational study of Infection, run by Philipp Schuetz at 3 sites in 3 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- How many people
- 150 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Feb 2013to Sep 2014
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: One cohort of 150-250 patients, possible infection at initial presentation in Kantonsspital Aarau.
Who may be able to join
- Age > 18 years
- possible infection at initial presentation
- informed consent
Who cannot join
- none
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
France1 site
Pitié Salpetrière. Groupement hospitalière universitaire Est
Paris, Paris, 7565
Germany1 site
Klinikum Ernst von Bergmann, gemeinnützige GmbH Akademisches Lehrkrankenhaus der Humboldt-Universität Berlin (Charité)
Potsdam, 14467
Switzerland1 site
Kantonsspital Aarau Innere Medizin
Aarau, Canton of Aargau, 5001
About this study
Official title: Technical Evaluation of a Whole Blood Rapid Test Measuring Procalcitonin (BRAHMS PCT Direct)
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.
Read the 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.
- Conditions
- Infection
- Keywords
- Procalcitonin, Infection, Point-of-Care
- Medical subject headings
- Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes (1)
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.
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Philipp Schuetz
- Sponsor type
- University, hospital or other
- Collaborators
- Thermo Fisher Scientific, Inc
- Responsible party
- Sponsor-investigator, Philipp Schuetz, University Hospital, Basel, Switzerland
- Investigators
- Philipp Schuetz, PD, Dr.med., Principal investigator, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771029
- Sponsor's protocol ID
- POC_1
- Status last verified
- Dec 2014
- First submitted
- 9 Jan 2013
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Evaluation of a Whole Blood Rapid Test Measuring Procalcitonin (BRAHMS PCT Direct)
- ClinicalTrials.gov ID
- NCT01771029
- Acronym / sponsor ID
- POC_1
- Conditions
- Infection
- Keywords
- Procalcitonin, Infection, Point-of-Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Philipp SchuetzUniversity, hospital or other
- Collaborators
- Thermo Fisher Scientific, Inc
- Study start
- Feb 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One cohort of 150-250 patients, possible infection at initial presentation in Kantonsspital Aarau.
Key inclusion criteria (3 listed)
- Age > 18 years
- possible infection at initial presentation
- informed consent
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Time to result
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Schuetz, PD, Dr.med. principal investigator
Kantonsspital Aarau
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by Philipp Schuetz at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2014; AzTrials last refreshed its copy on 5 Nov 2026.