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| ID | Type | Description | Link |
|---|---|---|---|
| NTR1861 | Other Identifier | Nederlands Trial Register |
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| Name | Class |
|---|---|
| UMC Utrecht | OTHER |
| Elisabeth-TweeSteden Ziekenhuis | OTHER |
| Diakonessenhuis, Utrecht | OTHER |
| Isala |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| procalcitonin-guidance | Active Comparator | A daily advise to continue or stop antibiotics based on the measurement of the biomarker procalcitonin |
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| standard-of-care | No Intervention | standard-of-care treatment of ICU infections based upon consensus guidelines and expert opinion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| procalcitonin-guidance | Other | If procalcitonin levels decrease to predefined levels, antibiotic therapy will be discontinued. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 28 days | |
| Consumption of antibiotics expressed as the Defined Daily Dosage and duration of antibiotic therapy expressed in days of therapy. | Between day 1 and D28 | |
| Mortality | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Length of ICU stay | Between D1 and D28 | |
| Acquisition costs of antibiotics | Expressed in euro's | Between D1-D28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evelien de Jong, MSc | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU University medical center | Amsterdam | 1081 HV | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36817782 | Derived | 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. | |
| 26947523 |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| D007239 | Infections |
| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OTHER |
| Atrium Medical Center | OTHER |
| Dijklander Ziekenhuis | OTHER |
| Bronovo Hospital | OTHER |
| Medical Center Haaglanden | OTHER |
| Slotervaart Hospital | OTHER |
| University of Groningen | OTHER |
| Martini Hospital Groningen | OTHER |
| Canisius-Wilhelmina Hospital | OTHER |
| Medisch Spectrum Twente | OTHER |
| St. Lucas Andreas Ziekenhuis Hospital | OTHER |
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| Acquisition costs of procalcitonin |
Expressed in euro's |
| Between D1-D28 |
| Derived |
| de 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. |
| 23590389 | Derived | Assink-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. |
| D012769 | Shock |