Bacterial InfectionNCT02311816
Increase in Procalcitonin Kinetics May be a Good Indicator of Starting Empirical Antibiotic Treatment in Critically Ill Patients
An observational study of Bacterial Infection, run by Domonkos Trásy at 1 site in Hungary.
Trial summary
The value of procalcitonin change from the day before to the day when infection was suspected in predicting bacterial infection in intensive care patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infection
- How many people
- 114 participants
- Where
- 1 siteHungary
- Study dates
- Oct 2012to Oct 2013
- 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: All patients with suspected infection during their stay on the intensive care unit were screened for eligibility. Patients were enrolled, when the attending intensive care specialist had a suspicion of infection and decided to start empirical antibiotic therapy and infalmmatory markers were available from the previous day.
Who may be able to join
- Clinical signs of infection
- Suspected or proven acute infection requiring empiric antibiotic therapy as decided by the attending ICU physician
- Microbiological sample sent for staining
- Inflammatory markers available from the previous day
Who cannot join
- Patients younger than 18 years
- Who received prophylactic or empiric antibiotic therapy 48 hours before inclusion
- Whose receiving acute renal replacement therapy in the first 24 hours following antibiotic treatment
- Following cardiopulmonary resuscitation
- End stage diseases with a "do not resuscitate" order
- Immunocompromised patients (human immunodeficiency virus infection, bone marrow transplantation, malignant haematological disorders and chemotherapy)
- Post cardiac surgery patients
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Department of Anaesthesiology and Intensive Therapy
Szeged, Csongrád megye, H-6725
About this study
The value of procalcitonin change from the day before to the day when infection was suspected in predicting bacterial infection in intensive care patients.
Read the detailed description
Starting antibiotic therapy early in critically ill patients with suspected infection is of utmost importance with significant effect on survival. Procalcitonin is a reliable sepsis marker but results about its usefulness in initiating antimicrobials are conflicting. Our aim is to investigate the predictive value of 24 hours procalcitonin kinetics before starting empirical antibiotic therapy in intensive care patients as an indicator of the presence of bacterial infection.
- Conditions
- Bacterial Infection
- Keywords
- Bacterial infection, empiric antibiotic therapy
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infection | Based on the microbiological results and clinical picture patients were grouped post hoc into "infection" and "no infection" groups by two independent experts (intensivist, infectologist) who were blinded for procalcitonin. | |
| No infection | Based on the microbiological results and clinical picture patients were grouped post hoc into "infection" and "no infection" groups by two independent experts (intensivist, infectologist) who were blinded for procalcitonin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procalcitonin kinetic
Procalcitonin levels are measured at starting empiric antibiotic treatment and 24 hours before. The changes in percentage are calculated form the day before and right before the first exposition of the antibiotic therapy.
Measured: 24 hours before starting empiric antibiotic treatment
Secondary outcomes (3)
C-reactive protein kinetic
C-reactive protein levels are measured at starting empiric antibiotic treatment and 24 hours before. The changes in percentage are calculated form the day before and right before the first exposition of the antibiotic therapy.
Measured: 24 hours before starting empiric antibiotic treatment
Body temperature kinetic
Body temperatures are measured at starting empiric antibiotic treatment and 24 hours before. The changes in percentage are calculated form the day before and right before the first exposition of the antibiotic therapy.
Measured: 24 hours before starting empiric antibiotic treatment
White blood cell count kinetic
White blood cell count levels are measured at starting empiric antibiotic treatment and 24 hours before. The changes in percentage are calculated form the day before and right before the first exposition of the antibiotic therapy.
Measured: 24 hours before starting empiric antibiotic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startOct 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Domonkos Trásy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Domonkos Trásy, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311816
- Sponsor's protocol ID
- PCT-infection
- Status last verified
- Dec 2014
- First submitted
- 4 Dec 2014
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Trasy D, Tanczos K, Nemeth M, Hankovszky P, Lovas A, Mikor A, Hajdu E, Osztroluczki A, Fazakas J, Molnar Z. Delta Procalcitonin Is a Better Indicator of Infection Than Absolute Procalcitonin Values in Critically Ill Patients: A Prospective Observational Study. J Immunol Res. 2016;2016:3530752. doi: 10.1155/2016/3530752. Epub 2016 Aug 15.
PubMed 27597981
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increase in Procalcitonin Kinetics May be a Good Indicator of Starting Empirical Antibiotic Treatment in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02311816
- Acronym / sponsor ID
- PCT-infection
- Conditions
- Bacterial Infection
- Keywords
- Bacterial infection, empiric antibiotic therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Domonkos TrásyUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 8 Dec 2014 (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.
The value of procalcitonin change from the day before to the day when infection was suspected in predicting bacterial infection in intensive care patients.
Detailed description
Starting antibiotic therapy early in critically ill patients with suspected infection is of utmost importance with significant effect on survival. Procalcitonin is a reliable sepsis marker but results about its usefulness in initiating antimicrobials are conflicting. Our aim is to investigate the predictive value of 24 hours procalcitonin kinetics before starting empirical antibiotic therapy in intensive care patients as an indicator of the presence of bacterial infection.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infection | – | –Based on the microbiological results and clinical picture patients were grouped post hoc into "infection" and "no infection" groups by two independent experts (intensivist, infectologist) who were blinded for procalcitonin. |
| No infection | – | –Based on the microbiological results and clinical picture patients were grouped post hoc into "infection" and "no infection" groups by two independent experts (intensivist, infectologist) who were blinded for procalcitonin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with suspected infection during their stay on the intensive care unit were screened for eligibility. Patients were enrolled, when the attending intensive care specialist had a suspicion of infection and decided to start empirical antibiotic therapy and infalmmatory markers were available from the previous day.
Key inclusion criteria (4 listed)
- Clinical signs of infection
- Suspected or proven acute infection requiring empiric antibiotic therapy as decided by the attending ICU physician
- Microbiological sample sent for staining
- Inflammatory markers available from the previous day
Key exclusion criteria (7 listed)
- Patients younger than 18 years
- Who received prophylactic or empiric antibiotic therapy 48 hours before inclusion
- Whose receiving acute renal replacement therapy in the first 24 hours following antibiotic treatment
- Following cardiopulmonary resuscitation
- End stage diseases with a "do not resuscitate" order
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
Procalcitonin kinetic
Time frame: 24 hours before starting empiric antibiotic treatment
Procalcitonin levels are measured at starting empiric antibiotic treatment and 24 hours before. The changes in percentage are calculated form the day before and right before the first exposition of the antibiotic therapy.
3 secondary outcomes
C-reactive protein kinetic
Time frame: 24 hours before starting empiric antibiotic treatment
Body temperature kinetic
Time frame: 24 hours before starting empiric antibiotic treatment
White blood cell count kinetic
Time frame: 24 hours before starting empiric antibiotic treatment
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 8 Dec 2014.
- Derived from this study: PubMed 27597981Trasy D, Tanczos K, Nemeth M, Hankovszky P, Lovas A, Mikor A, Hajdu E, Osztroluczki A, Fazakas J, Molnar Z. Delta Procalcitonin Is a Better Indicator of Infection Than Absolute Procalcitonin Values in Critically Ill Patients: A Prospective Observational Study. J Immunol Res. 2016;2016:3530752. doi: 10.1155/2016/3530752. Epub 2016 Aug 15.
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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.
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 Bacterial Infection, run by Domonkos Trásy at 1 site in Hungary.
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 4 inclusion and 7 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 8 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 1 site in Hungary. 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?
Procalcitonin kinetic (time frame: 24 hours before starting empiric antibiotic treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02311816, which also lists 1 linked publication.
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 8 Dec 2014; AzTrials last refreshed its copy on 6 Nov 2026.