The Value of Procalcitonin in Patients With Suspected CandidemiaNCT05385107
Value of PCT When Diagnosing Candidemia
An observational study of The Value of Procalcitonin in Patients With Suspected Candidemia, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
This study is a retrospective analysis to identify and compare the shift in inflammatory biomarkers in ICU patients immediately before and after the first identification of candidemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- The Value of Procalcitonin in Patients With Suspected Candidemia
- What is being tested?
- Serum procalcitonin concentration
- How many people
- 49 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2010to 12 Dec 2021
- 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: Intensive care patients
Who may be able to join
- ICU patients with blood cultures showing growth of Candida species
- clinical records including daily data on WBC, CRP, Procalcitonin and body temperature
Who cannot join
- Age lower than 18 years
- blood cultures with growth of Candida species before ICU admission
- incomplete records of daily WBC, CRP, Procalcitonin or body temperature
Trial locations and contacts
1 site in 1 country.
About this study
This study is a retrospective analysis to identify and compare the shift in inflammatory biomarkers in ICU patients immediately before and after the first identification of candidemia.
Read the detailed description
As above.
- Being tested
- Serum procalcitonin concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum procalcitonin concentrationDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute procalcitonin concentration
Measured: 9 days
Shift (trend) procalcitonin concentration
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 Apr 2010
- Primary completion31 Dec 2015
- Study completion12 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Value of Procalcitonin in Patients With Suspected CandidemiaStudies 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
- Retrospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Petersson, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385107
- Sponsor's protocol ID
- EPN 2017/806-31 (Candida-PCT)
- Status last verified
- May 2022
- First submitted
- 12 Dec 2021
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No plan
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of PCT When Diagnosing Candidemia
- ClinicalTrials.gov ID
- NCT05385107
- Acronym / sponsor ID
- EPN 2017/806-31 (Candida-PCT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2010 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 12 Dec 2021 (actual)
- First posted
- 23 May 2022 (actual)
- 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.
This study is a retrospective analysis to identify and compare the shift in inflammatory biomarkers in ICU patients immediately before and after the first identification of candidemia.
Detailed description
As above.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care patients
Key inclusion criteria (2 listed)
- ICU patients with blood cultures showing growth of Candida species
- clinical records including daily data on WBC, CRP, Procalcitonin and body temperature
Key exclusion criteria (3 listed)
- Age lower than 18 years
- blood cultures with growth of Candida species before ICU admission
- incomplete records of daily WBC, CRP, Procalcitonin or body temperature
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum procalcitonin concentration | Diagnostic test | – |
Primary outcome
Absolute procalcitonin concentration
Time frame: 9 days
Shift (trend) procalcitonin concentration
Time frame: 9 days
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 23 May 2022.
- Individual participant dataSharing planned: Undecided. No plan
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Value of Procalcitonin in Patients With Suspected Candidemia, run by Karolinska University Hospital at 1 site in Sweden.
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 2 inclusion and 3 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 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
Absolute procalcitonin concentration (time frame: 9 days). The study lists 2 primary outcomes in all. 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 23 May 2022.