SepsisSAPSNCT01139489
Safety and Efficacy of Procalcitonin Guided Antibiotic Therapy in Adult Intensive Care Units (ICU's)
A study testing procalcitonin-guidance in people with Sepsis and Severe Sepsis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
This is a randomized controlled trial comparing standard-of-care therapy of infections in critically ill patients with a procalcitonin-guided approach evaluating efficacy (antibiotics consumption) and safety (mortality). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Severe Sepsis, Septic Shock
- What is being tested?
- procalcitonin-guidance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,575 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2009to Aug 2014
- 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
- Age over 18 years old
- receiving antibiotics for no more than 24 hours for an assumed or proven infection
- Informed consent
Who cannot join
- Failure to obtain written consent to participate
- Patients receiving prolonged antibiotic therapies (> 3 weeks, e.g. endocarditis, cerebral/hepatic abscess)
- Patients with severe infections due to viruses or parasites (e.g. Dengue, Toxoplasma gondii, Plasmodium spp.)
- Patients infected with Mycobacterium tuberculosis
- Patients entering the ICU for post-operative observation and/or on antibiotic prophylaxis with an estimated length of stay less then 24 hrs.
- Patients suffering from cystic fibrosis
- Severely immunocompromised patients such as patients with HIV and with a CD4 count of less than 200 cells/mm, neutropenic patients (<500 neutrophils per mL) or patients with solid organ transplantation
- Moribund patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stop Antibiotics on Procalcitonin Guidance Study
This is a randomized controlled trial comparing standard-of-care therapy of infections in critically ill patients with a procalcitonin-guided approach evaluating efficacy (antibiotics consumption) and safety (mortality).
Read the detailed description
Antibiotics are prescribed widely in intensive care units and are linked with high costs and the occurence of antimicrobial (multi)resistance. The optimal duration of antibiotic treatment is poorly known and often based on consensus guidelines.
SAPS is a multicenter, prospective, randomized, controlled open-label trial evaluating the equivalence/efficacy and safety of procalcitonin-guided treatment of infections in ICU patients versus a standard-of-care approach.
All patients that are admitted to the ICU and for whom systemic antibiotics are prescribed for presumed or proven bacterial infections are eligible for this trial. Patients will be randomized and stratified according to clinical diagnosis of severe sepsis and septic shock. Any patient over the age of 18, admitted to the ICU and receiving antibiotics for an assumed infection can be enrolled into this trial. Informed consent has to be obtained in writing from the patient of his/her relatives prior to inclusion. In the intervention group daily procalcitonin levels be performed and will generate a non-binding stopping advice when predefined stopping-rules have been reached. The ultimate decision to stop antibiotics will be at the discretion of the physician in both groups.
- Conditions
- Sepsis, Severe Sepsis, Septic Shock
- Being tested
- procalcitonin-guidance
- Keywords
- Procalcitonin, antibiotic therapy, antibiotics, sepsis, infections, biomarker
- Medical subject headings
- Sepsis, Shock, Septic, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procalcitonin-guidanceOther
Also called PCT
If procalcitonin levels decrease to predefined levels, antibiotic therapy will be discontinued.
| Study group | Role | What they receive |
|---|---|---|
| procalcitonin-guidance | Active comparator | A daily advise to continue or stop antibiotics based on the measurement of the biomarker procalcitonin Receives: Other: procalcitonin-guidance |
| standard-of-care | No intervention | standard-of-care treatment of ICU infections based upon consensus guidelines and expert opinion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 28 days
Consumption of antibiotics expressed as the Defined Daily Dosage and duration of antibiotic therapy expressed in days of therapy.
Measured: Between day 1 and D28
Mortality
Measured: 1 year
Secondary outcomes (3)
Length of ICU stay
Measured: Between D1 and D28
Acquisition costs of antibiotics
Expressed in euro's
Measured: Between D1-D28
Acquisition costs of procalcitonin
Expressed in euro's
Measured: Between D1-D28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startNov 2009
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 1,575 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, Elisabeth-TweeSteden Ziekenhuis, Diakonessenhuis, Utrecht, Isala, Atrium Medical Center, Dijklander Ziekenhuis, Bronovo Hospital, Medical Center Haaglanden, Slotervaart Hospital, University of Groningen, Martini Hospital Groningen, Canisius-Wilhelmina Hospital, Medisch Spectrum Twente, St. Lucas Andreas Ziekenhuis Hospital
- Responsible party
- Principal investigator, Evelien de Jong, Amsterdam UMC, location VUmc
- Investigators
- Evelien de Jong, MSc, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139489
- Sponsor's protocol ID
- VU University medical center
- Other IDs
- NTR1861
- Acronym
- SAPS
- Status last verified
- Jan 2016
- First submitted
- 8 Mar 2010
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shajiei A, Berends MS, Luz CF, van Oers JA, Harmsen HJM, Vos P, Klont R, Loef BG, Reidinga AC, Bormans-Russell L, Linsen K, Dormans T, Otten M, van der Bij A, Beishuizen A, de Lange DW, de Jong E, Nijsten MW. Impact of reduced antibiotic treatment duration on antimicrobial resistance in critically ill patients in the randomized controlled SAPS-trial. Front Med (Lausanne). 2023 Feb 2;10:1080007. doi: 10.3389/fmed.2023.1080007. eCollection 2023.
PubMed 36817782de Jong E, van Oers JA, Beishuizen A, Vos P, Vermeijden WJ, Haas LE, Loef BG, Dormans T, van Melsen GC, Kluiters YC, Kemperman H, van den Elsen MJ, Schouten JA, Streefkerk JO, Krabbe HG, Kieft H, Kluge GH, van Dam VC, van Pelt J, Bormans L, Otten MB, Reidinga AC, Endeman H, Twisk JW, van de Garde EMW, de Smet AMGA, Kesecioglu J, Girbes AR, Nijsten MW, de Lange DW. Efficacy and safety of procalcitonin guidance in reducing the duration of antibiotic treatment in critically ill patients: a randomised, controlled, open-label trial. Lancet Infect Dis. 2016 Jul;16(7):819-827. doi: 10.1016/S1473-3099(16)00053-0. Epub 2016 Mar 2.
PubMed 26947523Assink-de Jong E, de Lange DW, van Oers JA, Nijsten MW, Twisk JW, Beishuizen A. Stop Antibiotics on guidance of Procalcitonin Study (SAPS): a randomised prospective multicenter investigator-initiated trial to analyse whether daily measurements of procalcitonin versus a standard-of-care approach can safely shorten antibiotic duration in intensive care unit patients--calculated sample size: 1816 patients. BMC Infect Dis. 2013 Apr 16;13:178. doi: 10.1186/1471-2334-13-178.
PubMed 23590389
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stop Antibiotics on Procalcitonin Guidance Study
- ClinicalTrials.gov ID
- NCT01139489
- Acronym / sponsor ID
- SAPS / VU University medical center
- Conditions
- Sepsis, Severe Sepsis, Septic Shock
- Keywords
- Procalcitonin, antibiotic therapy, antibiotics, sepsis, infections, biomarker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,575 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- UMC Utrecht, Elisabeth-TweeSteden Ziekenhuis, Diakonessenhuis, Utrecht, Isala, Atrium Medical Center, Dijklander Ziekenhuis, Bronovo Hospital, Medical Center Haaglanden, Slotervaart Hospital, University of Groningen, Martini Hospital Groningen, Canisius-Wilhelmina Hospital, Medisch Spectrum Twente, St. Lucas Andreas Ziekenhuis Hospital
- Study start
- Nov 2009
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Jun 2010 (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 randomized controlled trial comparing standard-of-care therapy of infections in critically ill patients with a procalcitonin-guided approach evaluating efficacy (antibiotics consumption) and safety (mortality).
Detailed description
Antibiotics are prescribed widely in intensive care units and are linked with high costs and the occurence of antimicrobial (multi)resistance. The optimal duration of antibiotic treatment is poorly known and often based on consensus guidelines.
SAPS is a multicenter, prospective, randomized, controlled open-label trial evaluating the equivalence/efficacy and safety of procalcitonin-guided treatment of infections in ICU patients versus a standard-of-care approach.
All patients that are admitted to the ICU and for whom systemic antibiotics are prescribed for presumed or proven bacterial infections are eligible for this trial. Patients will be randomized and stratified according to clinical diagnosis of severe sepsis and septic shock. Any patient over the age of 18, admitted to the ICU and receiving antibiotics for an assumed infection can be enrolled into this trial. Informed consent has to be obtained in writing from the patient of his/her relatives prior to inclusion. In the intervention group daily procalcitonin levels be performed and will generate a non-binding stopping advice when predefined stopping-rules have been reached. The ultimate decision to stop antibiotics will be at the discretion of the physician in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| procalcitonin-guidance | Active comparator | Other: procalcitonin-guidanceA daily advise to continue or stop antibiotics based on the measurement of the biomarker procalcitonin |
| standard-of-care | No intervention | –standard-of-care treatment of ICU infections based upon consensus guidelines and expert opinion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18 years old
- receiving antibiotics for no more than 24 hours for an assumed or proven infection
- Informed consent
Key exclusion criteria (8 listed)
- Failure to obtain written consent to participate
- Patients receiving prolonged antibiotic therapies (> 3 weeks, e.g. endocarditis, cerebral/hepatic abscess)
- Patients with severe infections due to viruses or parasites (e.g. Dengue, Toxoplasma gondii, Plasmodium spp.)
- Patients infected with Mycobacterium tuberculosis
- Patients entering the ICU for post-operative observation and/or on antibiotic prophylaxis with an estimated length of stay less then 24 hrs.
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 |
|---|---|---|
| procalcitonin-guidanceAlso: PCTIf procalcitonin levels decrease to predefined levels, antibiotic therapy will be discontinued. | Other | procalcitonin-guidance |
Primary outcome
Mortality
Time frame: 28 days
Consumption of antibiotics expressed as the Defined Daily Dosage and duration of antibiotic therapy expressed in days of therapy.
Time frame: Between day 1 and D28
Mortality
Time frame: 1 year
3 secondary outcomes
Length of ICU stay
Time frame: Between D1 and D28
Acquisition costs of antibiotics
Time frame: Between D1-D28
Acquisition costs of procalcitonin
Time frame: Between D1-D28
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 6 Jan 2016.
- Derived from this study: PubMed 36817782Shajiei A, Berends MS, Luz CF, van Oers JA, Harmsen HJM, Vos P, Klont R, Loef BG, Reidinga AC, Bormans-Russell L, Linsen K, Dormans T, Otten M, van der Bij A, Beishuizen A, de Lange DW, de Jong E, Nijsten MW. Impact of reduced antibiotic treatment duration on antimicrobial resistance in critically ill patients in the randomized controlled SAPS-trial. Front Med (Lausanne). 2023 Feb 2;10:1080007. doi: 10.3389/fmed.2023.1080007. eCollection 2023.
- Derived from this study: PubMed 26947523de Jong E, van Oers JA, Beishuizen A, Vos P, Vermeijden WJ, Haas LE, Loef BG, Dormans T, van Melsen GC, Kluiters YC, Kemperman H, van den Elsen MJ, Schouten JA, Streefkerk JO, Krabbe HG, Kieft H, Kluge GH, van Dam VC, van Pelt J, Bormans L, Otten MB, Reidinga AC, Endeman H, Twisk JW, van de Garde EMW, de Smet AMGA, Kesecioglu J, Girbes AR, Nijsten MW, de Lange DW. Efficacy and safety of procalcitonin guidance in reducing the duration of antibiotic treatment in critically ill patients: a randomised, controlled, open-label trial. Lancet Infect Dis. 2016 Jul;16(7):819-827. doi: 10.1016/S1473-3099(16)00053-0. Epub 2016 Mar 2.
- Derived from this study: PubMed 23590389Assink-de Jong E, de Lange DW, van Oers JA, Nijsten MW, Twisk JW, Beishuizen A. Stop Antibiotics on guidance of Procalcitonin Study (SAPS): a randomised prospective multicenter investigator-initiated trial to analyse whether daily measurements of procalcitonin versus a standard-of-care approach can safely shorten antibiotic duration in intensive care unit patients--calculated sample size: 1816 patients. BMC Infect Dis. 2013 Apr 16;13:178. doi: 10.1186/1471-2334-13-178.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Evelien de Jong, MSc principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing procalcitonin-guidance in people with Sepsis and Severe Sepsis, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 8 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 6 Jan 2016. 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 Netherlands. 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?
Mortality (time frame: 28 days). The study lists 3 primary outcomes in all. 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 NCT01139489, which also lists 3 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 6 Jan 2016.