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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.

ABSTRACT: Unnecessary long-term use of broad-spectrum antibiotics is linked to the emergence and selection of resistant bacteria, prolonged hospitalisation and increased costs. Several clinical trials indicate that the biomarker procalcitonin (PCT) can guide antibiotic therapy. Some of these trials have shown a promising reduction in the number of antibiotic prescriptions, duration of antibiotic therapy and even length of stay in the ICU, although their size and selection criteria limit their external validity. The objectives of the Stop Antibiotics on guidance of Procalcitonin Study (SAPS) are to evaluate whether daily PCT can improve "real-life" antibiotic use in Dutch ICU's by reduction of the duration of antibiotic treatment without an increase of recurrent infections and mortality.Multicenter randomised controlled intervention trial. Powered for superiority of the primary efficacy endpoint and non-inferiority on the primary safety endpoints (non-inferiority margin is set on 8%).(1) ICU-patients aged ?18 years and (2) receiving antibiotics for a presumed or proven infection and (3) signed informed consent.(1) patients who require prolonged antibiotic therapy, (2) suffer from Mycobacterium tuberculosis, (3) cystic fibrosis, (4) viral or parasitic infections and (5) those that are severely immunocompromised or (6) moribund.The intervention consists solely of an advice to discontinue antibiotic treatment in case PCT has decreased by more than 80% of its peak level (relative stopping threshold) or decrease below a value of 0.5 ng/ml (absolute stopping threshold).The study hypothesis is that PCT-guided therapy is non-inferior to standard care based on implemented guidelines and local expertise, whilst reducing antibiotic usage. Computerised 1:1 randomisation will allocate 908 patients per arm. Arm 1: standard of care. Arm 2: procalcitonin-guided therapy. The primary efficacy endpoint is consumption of antibiotics expressed as the defined daily dosage and duration of antibiotic therapy expressed in days of therapy. This trial is designed to shorten antibiotics safely, therefore the primary safety endpoint is mortality measured at 28 day and 1 year.This will be the largest procalcitonin-guided antibiotic intervention trial in ICU setting thus far. Currently 1600 of the planned 1816 patients are randomised (November 2012). The first interim analysis has passed without any safety or futility issues.Trial registration number at www.clinicaltrials.gov: Id. Nr. NCT01139489, at www.trialregister.nl: Id.nr. NTR1861.

SUBMITTER: Assink-de Jong E

PROVIDER: S-EPMC3637799 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature

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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.

Assink-de Jong Evelien E de Lange Dylan W DW van Oers Jos A JA Nijsten Maarten W MW Twisk Jos W JW Beishuizen Albertus A

BMC infectious diseases 20130416

<h4>Background</h4>Unnecessary long-term use of broad-spectrum antibiotics is linked to the emergence and selection of resistant bacteria, prolonged hospitalisation and increased costs. Several clinical trials indicate that the biomarker procalcitonin (PCT) can guide antibiotic therapy. Some of these trials have shown a promising reduction in the number of antibiotic prescriptions, duration of antibiotic therapy and even length of stay in the ICU, although their size and selection criteria limit ...[more]

PMID: 23590389

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Project 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. The infectious status of the critically ill patient is often difficult to assess because symptoms cannot be expressed and signs may present atypically. The established biological markers of inflammation (leucocytes, C-reactive protein) may often be influenced by other parameters than infection, 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. Specific and rapid markers of bacterial infection have been sought for use in these patients.Multi-centre randomized controlled interventional trial. Powered for superiority and non-inferiority on all measured end points. Complies with, "Good Clinical Practice" (ICH-GCP Guideline (CPMP/ICH/135/95, Directive 2001/20/EC)). Inclusion: 1) Age > or = 18 years of age, 2) Admitted to the participating intensive care units, 3) Signed written informed consent.Exclusion: 1) Known hyper-bilirubinaemia. or hypertriglyceridaemia, 2) Likely that safety is compromised by blood sampling, 3) Pregnant or breast feeding. Computerized Randomisation: Two arms (1:1), n = 500 per arm: Arm 1: standard of care. Arm 2: standard of care and Procalcitonin guided diagnostics and treatment of infection. Primary Trial Objective: To address whether daily Procalcitonin measurements and immediate diagnostic and therapeutic response on day-to-day changes in procalcitonin can reduce the mortality of critically ill patients.For the first time ever, a mortality-endpoint, large scale randomized controlled trial with a biomarker-guided strategy compared to the best standard of care, is conducted in an Intensive care setting. Results will, with a high statistical power answer the question: Can the survival of critically ill patients be improved by actively using biomarker procalcitonin in the treatment of infections? 700 critically ill patients are currently included of 1000 planned (June 2008). Two interim analyses have been passed without any safety or futility issues, and the third interim analysis is soon to take place. Trial registration number at clinicaltrials.gov: Id. nr.: NCT00271752).

Project description:OBJECTIVE:To analyze and compare the performance of the Simplified-Acute-Physiology-Score (SAPS) 2 and SAPS 3 among intermediate care patients with internal disorders. MATERIALS AND METHODS:We conducted a retrospective single-center analysis in patients (n = 305) admitted to an intermediate-care-unit (ImCU) for internal medicine at the University Hospital Essen, Germany. We employed and compared the SAPS 2 vs. the SAPS 3 scoring system for the assessment of disease severity and prediction of mortality rates among patients admitted to the ImCU within an 18-month period. Both scores, which utilize parameters recorded at admission to the intensive-care-unit (ICU), represent the most widely applied scoring systems in European intensive care medicine. The area-under-the-receiver-operating-characteristic-curve (AUROC) was used to evaluate the SAPS 2 and SAPS 3 discrimination performance. Ultimately, standardized-mortality-ratios (SMRs) were calculated alongside their respective 95%-confidence-intervals (95% CI) in order to determine the observed-to-expected death ratio and calibration belt plots were generated to evaluate the SAPS 2 and SAPS 3 calibration performance. RESULTS:Both scores provided acceptable discrimination performance, i.e., the AUROC was 0.71 (95% CI, 0.65-0.77) for SAPS 2 and 0.77 (95% CI, 0.72-0.82) for SAPS 3. Against the observed in-hospital mortality of 30.2%, SAPS 2 showed a weak performance with a predicted mortality of 17.4% and a SMR of 1.74 (95% CI, 1.38-2.09), especially in association with liver diseases and/or sepsis. SAPS 3 performed accurately, resulting in a predicted mortality of 29.9% and a SMR of 1.01 (95% CI, 0.8-1.21). Based on Calibration belt plots, SAPS 2 showed a poor calibration-performance especially in patients with low mortality risk (P<0.001), while SAPS 3 exhibited a highly accurate calibration performance (P = 0.906) across all risk levels. CONCLUSIONS:In our study, the SAPS 3 exhibited high accuracy in prediction of mortality in ImCU patients with internal disorders. In contrast, the SAPS 2 underestimated mortality particularly in patients with liver diseases and sepsis.

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