Localized InfectionPASSNCT00271752
The Procalcitonin and Survival Study
A study testing Earlier therapeutic changes regarding infection in people with Localized Infection and Sepsis, run by Danish Procalcitonin Study Group at 9 sites in Denmark.
Trial summary
This is a randomised, single blinded, multicentre trial to evaluate whether daily procalcitonin (PCT) measurements and immediate diagnostic and therapeutic responses to abnormal values and day-to-day changes can reduce the mortality of critically ill patients in the Intensive Care Unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Localized Infection, Sepsis, Multiple Organ Failure
- What is being tested?
- Earlier therapeutic changes regarding infection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 9 sitesDenmark
- Study dates
- Jan 2006to Sep 2009
- Phase
- Interventional
- 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
Who may be able to join
- Fulfilment of all of the following three criteria:
- Male or female, aged > 18 years of age.
- Admitted to the participating Intensive Care Units (ICUs) at the following hospitals: Hvidovre Hospital, Bispebjerg Hospital, Amager Hospital, Herlev Hospital, Glostrup Hospital, and Gentofte Hospital
- Ability to understand and provide written informed consent to participate in this trial; or ability to understand and provide oral informed consent in the presence of at least one impartial witness who should sign and personally date the consent form; or the subject's legally acceptable representative can understand and provide written informed consent if the subject is not capable of this because of the present mental or physical condition of the subject.
Who cannot join
- A subject will NOT be eligible for inclusion in this trial if any of the following criteria apply:
- Subjects with known hyperbilirubinaemia (> 0.4 mg/ml) or hypertriglyceridaemia (> 10 g/l) since this can interfere with measurements. If subjects with unknown status on these points are included and have PCT measurements, the measuring equipment will detect these conditions.
- Subjects suffering from a blood disorder, where daily sampling of 7 ml of blood for a maximum of 28 days (210 ml distributed on 28 days) will be an inconvenience or a potential risk, which could compromise the safety of the subject.
- Subjects who are pregnant or breast feeding
- The a priori probability of surviving with the normal recommended diagnostics and treatment with the presently available means to detect infections and, on the other hand, the normal diagnostics and treatment together with daily procalcitonin measurements and prompt clinical reaction should be equal.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Denmark9 sites
Intensive Care Unit, Århus Sygehus, Nørrebrogade
Aarhus, Central Jutland, DK-8000
Intensive Care Unit, Bispebjerg Hospital
Copenhagen NV, Copenhagen, DK-2400
Intensive Care Unit, KAS Gentofte
Gentofte Municipality, Copenhagen, DK-2820
Intensive Care Unit, KAS Glostrup, Copenhagen University Hospital
Glostrup Municipality, Copenhagen, DK-2600
Intensive Care Unit, Herlev Hospital
Herlev, Copenhagen, DK-2730
Intensive Care Unit, Hilleroed Sygehus
Hilleroed, Frederiksborg County, DK-3400
Intensive Care Unit 542, Hvidovre Hospital, Copenhagen University Hospital
Hvidovre, Copenhagen, DK-2650
Roskilde Sygehus
Roskilde, Region Sjælland, DK-4000
Skejby Sygehus
Skejby, Århus, Central Jutland, DK-8200
About this study
Official title: The Procalcitonin and Survival Study - A Multicentre Single Blinded Randomized Controlled Trial to Investigate if Treatment Guided by Daily Procalcitonin Measurements Can Reduce Mortality in the Intensive Care Unit
This is a randomised, single blinded, multicentre trial to evaluate whether daily procalcitonin (PCT) measurements and immediate diagnostic and therapeutic responses to abnormal values and day-to-day changes can reduce the mortality of critically ill patients in the Intensive Care Unit (ICU).
Read the detailed description
Sepsis and complications to sepsis are major causes of mortality in critically ill patients. Rapid treatment of sepsis is of crucial importance for survival of patients. In the ICU, the infectious status of the patient is often difficult to assess because symptoms cannot be expressed (unconscious or sedated patients) and signs may present atypically because of immunologic incompetence and masking by the drugs given and thermo-therapy. Biological and biochemical markers of inflammation (White Blood Cells (WBC), C-reactive protein) may often be influenced by other parameters than infection, such as: trauma, surgery, other types of inflammation such as rheumatoid diseases (C-reactive protein) and gluco-corticosteroid treatment (WBC), and may be unacceptably slowly released after progression of an infection. At the same time, lack of a relevant antimicrobial therapy in an early course of infection may be fatal for the patient.
For these reasons, in the clinical setting, it is often necessary to initiate or adjust antimicrobial therapy on an unsure ground and the relevant therapy may in some situations be delayed for important hours or even days. Specific and rapid markers of bacterial infection have been sought for use in the ICU. Mortality in critically ill patients increases gravely when Procalcitonin levels increase from day to day (own submitted, though yet unpublished data). Low PCT levels have been shown to effectively rule out sepsis.
However, no randomised controlled trials have been conducted to show if mortality in critically ill patients can be reduced by using a strategy of daily standardised Procalcitonin measurements as an early detector of serious bacterial infection. Therefore evidence is presently not sufficient to introduce daily consecutive Procalcitonin measurements to guide the diagnostic and therapeutic management of patients admitted to the ICU .
The rationale for this trial is to assess the ability of daily Procalcitonin measurements to reduce the mortality of critically ill patients.
- Conditions
- Localized Infection, Sepsis, Multiple Organ Failure
- Being tested
- Earlier therapeutic changes regarding infection
- Keywords
- Procalcitonin, Sepsis, Intensive Care Unit, Sepsis and Complications, Organ Failure
- Medical subject headings
- Focal Infection, Sepsis, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Earlier therapeutic changes regarding infectionProcedure or surgery
For every day Procalcitonin levels increase in the intervention group, antibiotics, surgery, diagnostic imaging and microbiologic testing is intensified
| Study group | Role | What they receive |
|---|---|---|
| PCT guided | Experimental | Procalcitonin guided treatment of infections in the ICU. Intervention: Intensification of antibiotics, surgery, microbiologic testing and diagnostic imaging, when Procalcitonin levels are increasing Receives: Procedure: Earlier therapeutic changes regarding infection |
| Control | Sham comparator | These patients receive "Standard of Care" which is the recommended treatment in the given ICU Receives: Procedure: Earlier therapeutic changes regarding infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality/survival
Measured: 28 day
Secondary outcomes (12)
mortality/survival
Measured: 60 day
mortality/survival
Measured: 90 day
mortality/survival
Measured: 120 day
mortality/survival
Measured: 180 day
Consumption of antimicrobial chemotherapy
Measured: 28 day
Prevalence of complications to infection: sepsis
Measured: 28 day
severe sepsis
Measured: 28 day
septic shock
Measured: 28 day
Multi Organ Dysfunction Syndrome
Measured: 28 day
Disseminated Intravascular Coagulation
Measured: 28 day
use of diagnostic imaging during admission to the ICU
Measured: 28 day
Quality of life post-ICU
Measured: 180 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Localized 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Procalcitonin Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen HIV Programme, Danish Research Agency, Hvidovre University Hospital
- Investigators
- Jens-Ulrik S Jensen, MD, PhD, Study director, Dept. of Clinical Microbiology, Hvidovre University Hospital & Copenhagen HIV Programme (CHIP), Faculty of Health Sciences, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271752
- Sponsor's protocol ID
- PASS
- Acronym
- PASS
- Status last verified
- Mar 2010
- First submitted
- 1 Jan 2006
- Last updated
- 4 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holm FS, Sivapalan P, Seersholm N, Itenov TS, Christensen PH, Jensen JS. Acute Lung Injury in Critically Ill Patients: Actin-Scavenger Gelsolin Signals Prolonged Respiratory Failure. Shock. 2019 Sep;52(3):370-377. doi: 10.1097/SHK.0000000000001279.
PubMed 30339635Jensen JS, Itenov TS, Thormar KM, Hein L, Mohr TT, Andersen MH, Loken J, Tousi H, Lundgren B, Boesen HC, Johansen ME, Ostrowski SR, Johansson PI, Grarup J, Vestbo J, Lundgren JD; Procalcitonin And Survival Study (PASS) Group. Prediction of non-recovery from ventilator-demanding acute respiratory failure, ARDS and death using lung damage biomarkers: data from a 1200-patient critical care randomized trial. Ann Intensive Care. 2016 Dec;6(1):114. doi: 10.1186/s13613-016-0212-y. Epub 2016 Nov 21.
PubMed 27873291Johansen ME, Johansson PI, Ostrowski SR, Bestle MH, Hein L, Jensen AL, Soe-Jensen P, Andersen MH, Steensen M, Mohr T, Thormar K, Lundgren B, Cozzi-Lepri A, Lundgren JD, Jensen JU. Profound endothelial damage predicts impending organ failure and death in sepsis. Semin Thromb Hemost. 2015 Feb;41(1):16-25. doi: 10.1055/s-0034-1398377. Epub 2015 Jan 15.
PubMed 25590523Johansen ME, Jensen JU, Bestle MH, Hein L, Lauritsen AO, Tousi H, Larsen KM, Loken J, Mohr T, Thormar K, Johansson PI, Cozzi-Lepri A, Lundgren JD. The potential of antimicrobials to induce thrombocytopenia in critically ill patients: data from a randomized controlled trial. PLoS One. 2013 Nov 28;8(11):e81477. doi: 10.1371/journal.pone.0081477. eCollection 2013.
PubMed 24312305Jensen JU, Hein L, Lundgren B, Bestle MH, Mohr T, Andersen MH, Thornberg KJ, Loken J, Steensen M, Fox Z, Tousi H, Soe-Jensen P, Lauritsen AO, Strange DG, Reiter N, Thormar K, Fjeldborg PC, Larsen KM, Drenck NE, Johansen ME, Nielsen LR, Ostergaard C, Kjaer J, Grarup J, Lundgren JD; Procalcitonin And Survival Study (PASS) Group. Kidney failure related to broad-spectrum antibiotics in critically ill patients: secondary end point results from a 1200 patient randomised trial. BMJ Open. 2012 Mar 11;2(2):e000635. doi: 10.1136/bmjopen-2011-000635. Print 2012.
PubMed 22411933Jensen JU, Hein L, Lundgren B, Bestle MH, Mohr TT, Andersen MH, Thornberg KJ, Loken J, Steensen M, Fox Z, Tousi H, Soe-Jensen P, Lauritsen AO, Strange D, Petersen PL, Reiter N, Hestad S, Thormar K, Fjeldborg P, Larsen KM, Drenck NE, Ostergaard C, Kjaer J, Grarup J, Lundgren JD; Procalcitonin And Survival Study (PASS) Group. Procalcitonin-guided interventions against infections to increase early appropriate antibiotics and improve survival in the intensive care unit: a randomized trial. Crit Care Med. 2011 Sep;39(9):2048-58. doi: 10.1097/CCM.0b013e31821e8791.
PubMed 21572328Jensen JU, Lundgren B, Hein L, Mohr T, Petersen PL, Andersen LH, Lauritsen AO, Hougaard S, Mantoni T, Bomler B, Thornberg KJ, Thormar K, Loken J, Steensen M, Carl P, Petersen JA, Tousi H, Soe-Jensen P, Bestle M, Hestad S, Andersen MH, Fjeldborg P, Larsen KM, Rossau C, Thomsen CB, Ostergaard C, Kjaer J, Grarup J, Lundgren JD. The Procalcitonin And Survival Study (PASS) - a randomised multi-center investigator-initiated trial to investigate whether daily measurements biomarker Procalcitonin and pro-active diagnostic and therapeutic responses to abnormal Procalcitonin levels, can improve survival in intensive care unit patients. Calculated sample size (target population): 1000 patients. BMC Infect Dis. 2008 Jul 13;8:91. doi: 10.1186/1471-2334-8-91.
PubMed 18620598
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Procalcitonin and Survival Study - A Multicentre Single Blinded Randomized Controlled Trial to Investigate if Treatment Guided by Daily Procalcitonin Measurements Can Reduce Mortality in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT00271752
- Acronym / sponsor ID
- PASS / PASS
- Conditions
- Localized Infection, Sepsis, Multiple Organ Failure
- Keywords
- Procalcitonin, Sepsis, Intensive Care Unit, Sepsis and Complications, Organ Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Danish Procalcitonin Study GroupUniversity, hospital or other
- Collaborators
- Copenhagen HIV Programme, Danish Research Agency, Hvidovre University Hospital
- Study start
- Jan 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 4 Jan 2006 (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.
This is a randomised, single blinded, multicentre trial to evaluate whether daily procalcitonin (PCT) measurements and immediate diagnostic and therapeutic responses to abnormal values and day-to-day changes can reduce the mortality of critically ill patients in the Intensive Care Unit (ICU).
Detailed description
Sepsis and complications to sepsis are major causes of mortality in critically ill patients. Rapid treatment of sepsis is of crucial importance for survival of patients. In the ICU, the infectious status of the patient is often difficult to assess because symptoms cannot be expressed (unconscious or sedated patients) and signs may present atypically because of immunologic incompetence and masking by the drugs given and thermo-therapy. Biological and biochemical markers of inflammation (White Blood Cells (WBC), C-reactive protein) may often be influenced by other parameters than infection, such as: trauma, surgery, other types of inflammation such as rheumatoid diseases (C-reactive protein) and gluco-corticosteroid treatment (WBC), and may be unacceptably slowly released after progression of an infection. At the same time, lack of a relevant antimicrobial therapy in an early course of infection may be fatal for the patient.
For these reasons, in the clinical setting, it is often necessary to initiate or adjust antimicrobial therapy on an unsure ground and the relevant therapy may in some situations be delayed for important hours or even days. Specific and rapid markers of bacterial infection have been sought for use in the ICU. Mortality in critically ill patients increases gravely when Procalcitonin levels increase from day to day (own submitted, though yet unpublished data). Low PCT levels have been shown to effectively rule out sepsis.
However, no randomised controlled trials have been conducted to show if mortality in critically ill patients can be reduced by using a strategy of daily standardised Procalcitonin measurements as an early detector of serious bacterial infection. Therefore evidence is presently not sufficient to introduce daily consecutive Procalcitonin measurements to guide the diagnostic and therapeutic management of patients admitted to the ICU .
The rationale for this trial is to assess the ability of daily Procalcitonin measurements to reduce the mortality of critically ill patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCT guided | Experimental | Procedure: Earlier therapeutic changes regarding infectionProcalcitonin guided treatment of infections in the ICU. Intervention: Intensification of antibiotics, surgery, microbiologic testing and diagnostic imaging, when Procalcitonin levels are increasing |
| Control | Sham comparator | Procedure: Earlier therapeutic changes regarding infectionThese patients receive "Standard of Care" which is the recommended treatment in the given ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged > 18 years of age.
- Admitted to the participating Intensive Care Units (ICUs) at the following hospitals: Hvidovre Hospital, Bispebjerg Hospital, Amager Hospital, Herlev Hospital, Glostrup Hospital, and Gentofte Hospital
- Ability to understand and provide written informed consent to participate in this trial; or ability to understand and provide oral informed consent in the presence of at least one impartial witness who should sign and personally date the consent form; or the subject's legally acceptable representative can understand and provide written informed consent if the subject is not capable of this because of the present mental or physical condition of the subject.
Key exclusion criteria (5 listed)
- A subject will NOT be eligible for inclusion in this trial if any of the following criteria apply:
- Subjects with known hyperbilirubinaemia (> 0.4 mg/ml) or hypertriglyceridaemia (> 10 g/l) since this can interfere with measurements. If subjects with unknown status on these points are included and have PCT measurements, the measuring equipment will detect these conditions.
- Subjects suffering from a blood disorder, where daily sampling of 7 ml of blood for a maximum of 28 days (210 ml distributed on 28 days) will be an inconvenience or a potential risk, which could compromise the safety of the subject.
- Subjects who are pregnant or breast feeding
- The a priori probability of surviving with the normal recommended diagnostics and treatment with the presently available means to detect infections and, on the other hand, the normal diagnostics and treatment together with daily procalcitonin measurements and prompt clinical reaction should be equal.
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 |
|---|---|---|
| Earlier therapeutic changes regarding infectionFor every day Procalcitonin levels increase in the intervention group, antibiotics, surgery, diagnostic imaging and microbiologic testing is intensified | Procedure or surgery | Control, PCT guided |
Primary outcome
mortality/survival
Time frame: 28 day
12 secondary outcomes
mortality/survival
Time frame: 60 day
mortality/survival
Time frame: 90 day
mortality/survival
Time frame: 120 day
mortality/survival
Time frame: 180 day
Consumption of antimicrobial chemotherapy
Time frame: 28 day
Prevalence of complications to infection: sepsis
Time frame: 28 day
severe sepsis
Time frame: 28 day
septic shock
Time frame: 28 day
Multi Organ Dysfunction Syndrome
Time frame: 28 day
Disseminated Intravascular Coagulation
Time frame: 28 day
use of diagnostic imaging during admission to the ICU
Time frame: 28 day
Quality of life post-ICU
Time frame: 180 day
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 4 Mar 2010.
- Derived from this study: PubMed 30339635Holm FS, Sivapalan P, Seersholm N, Itenov TS, Christensen PH, Jensen JS. Acute Lung Injury in Critically Ill Patients: Actin-Scavenger Gelsolin Signals Prolonged Respiratory Failure. Shock. 2019 Sep;52(3):370-377. doi: 10.1097/SHK.0000000000001279.
- Derived from this study: PubMed 27873291Jensen JS, Itenov TS, Thormar KM, Hein L, Mohr TT, Andersen MH, Loken J, Tousi H, Lundgren B, Boesen HC, Johansen ME, Ostrowski SR, Johansson PI, Grarup J, Vestbo J, Lundgren JD; Procalcitonin And Survival Study (PASS) Group. Prediction of non-recovery from ventilator-demanding acute respiratory failure, ARDS and death using lung damage biomarkers: data from a 1200-patient critical care randomized trial. Ann Intensive Care. 2016 Dec;6(1):114. doi: 10.1186/s13613-016-0212-y. Epub 2016 Nov 21.
- Derived from this study: PubMed 25590523Johansen ME, Johansson PI, Ostrowski SR, Bestle MH, Hein L, Jensen AL, Soe-Jensen P, Andersen MH, Steensen M, Mohr T, Thormar K, Lundgren B, Cozzi-Lepri A, Lundgren JD, Jensen JU. Profound endothelial damage predicts impending organ failure and death in sepsis. Semin Thromb Hemost. 2015 Feb;41(1):16-25. doi: 10.1055/s-0034-1398377. Epub 2015 Jan 15.
- Derived from this study: PubMed 24312305Johansen ME, Jensen JU, Bestle MH, Hein L, Lauritsen AO, Tousi H, Larsen KM, Loken J, Mohr T, Thormar K, Johansson PI, Cozzi-Lepri A, Lundgren JD. The potential of antimicrobials to induce thrombocytopenia in critically ill patients: data from a randomized controlled trial. PLoS One. 2013 Nov 28;8(11):e81477. doi: 10.1371/journal.pone.0081477. eCollection 2013.
- Derived from this study: PubMed 22411933Jensen JU, Hein L, Lundgren B, Bestle MH, Mohr T, Andersen MH, Thornberg KJ, Loken J, Steensen M, Fox Z, Tousi H, Soe-Jensen P, Lauritsen AO, Strange DG, Reiter N, Thormar K, Fjeldborg PC, Larsen KM, Drenck NE, Johansen ME, Nielsen LR, Ostergaard C, Kjaer J, Grarup J, Lundgren JD; Procalcitonin And Survival Study (PASS) Group. Kidney failure related to broad-spectrum antibiotics in critically ill patients: secondary end point results from a 1200 patient randomised trial. BMJ Open. 2012 Mar 11;2(2):e000635. doi: 10.1136/bmjopen-2011-000635. Print 2012.
- Derived from this study: PubMed 21572328Jensen JU, Hein L, Lundgren B, Bestle MH, Mohr TT, Andersen MH, Thornberg KJ, Loken J, Steensen M, Fox Z, Tousi H, Soe-Jensen P, Lauritsen AO, Strange D, Petersen PL, Reiter N, Hestad S, Thormar K, Fjeldborg P, Larsen KM, Drenck NE, Ostergaard C, Kjaer J, Grarup J, Lundgren JD; Procalcitonin And Survival Study (PASS) Group. Procalcitonin-guided interventions against infections to increase early appropriate antibiotics and improve survival in the intensive care unit: a randomized trial. Crit Care Med. 2011 Sep;39(9):2048-58. doi: 10.1097/CCM.0b013e31821e8791.
- Derived from this study: PubMed 18620598Jensen JU, Lundgren B, Hein L, Mohr T, Petersen PL, Andersen LH, Lauritsen AO, Hougaard S, Mantoni T, Bomler B, Thornberg KJ, Thormar K, Loken J, Steensen M, Carl P, Petersen JA, Tousi H, Soe-Jensen P, Bestle M, Hestad S, Andersen MH, Fjeldborg P, Larsen KM, Rossau C, Thomsen CB, Ostergaard C, Kjaer J, Grarup J, Lundgren JD. The Procalcitonin And Survival Study (PASS) - a randomised multi-center investigator-initiated trial to investigate whether daily measurements biomarker Procalcitonin and pro-active diagnostic and therapeutic responses to abnormal Procalcitonin levels, can improve survival in intensive care unit patients. Calculated sample size (target population): 1000 patients. BMC Infect Dis. 2008 Jul 13;8:91. doi: 10.1186/1471-2334-8-91.
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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.
Jens-Ulrik S Jensen, MD, PhD study director
Dept. of Clinical Microbiology, Hvidovre University Hospital & Copenhagen HIV Programme (CHIP), Faculty of Health Sciences, University of Copenhagen
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Earlier therapeutic changes regarding infection in people with Localized Infection and Sepsis, run by Danish Procalcitonin Study Group at 9 sites in Denmark.
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 5 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 4 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Denmark. 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. Some participants in this study may receive a placebo. 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?
mortality/survival (time frame: 28 day). 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 NCT00271752, which also lists 7 linked publications.
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 4 Mar 2010.