Catho Gaud, De Kraker Marlieke, Waldispühl Suter Brigitte, Valotti Roberta, Harbarth Stephan, Kaiser Laurent, Elzi Luigia, Meyer Rodolphe, Bernasconi Enos, Huttner Benedikt D
Division of Infectious Diseases, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.
Infection Control Program, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.
BMJ Open. 2018 Jun 27;8(6):e022666. doi: 10.1136/bmjopen-2018-022666.
Inappropriate use of antimicrobials in hospitals contributes to antimicrobial resistance. Antimicrobial stewardship (AMS) interventions aim to improve antimicrobial prescribing, but they are often resource and personnel intensive. Computerised decision supportsystems (CDSSs) seem a promising tool to improve antimicrobial prescribing but have been insufficiently studied in clinical trials.
The COMPuterized Antibiotic Stewardship Study trial, is a publicly funded, open-label, cluster randomised, controlled superiority trial which aims to determine whether a multimodal CDSS intervention integrated in the electronic health record (EHR) reduces overall antibiotic exposure in adult patients hospitalised in wards of two secondary and one tertiary care centre in Switzerland compared with 'standard-of-care' AMS. Twenty-four hospital wards will be randomised 1:1 to either intervention or control, using a 'pair-matching' approach based on baseline antibiotic use, specialty and centre. The intervention will consist of (1) decision support for the choice of antimicrobial treatment and duration of treatment for selected indications (based on indication entry), (2) accountable justification for deviation from the local guidelines (with regard to the choice of molecules and duration), (3) alerts for self-guided re-evaluation of treatment on calendar day 4 of antimicrobial therapy and (4) monthly ward-level feedback of antimicrobial prescribing indicators. The primary outcome will be the difference in overall systemic antibiotic use measured in days of therapy per admission based on administration data recorded in the EHR over the whole intervention period (12 months), taking into account clustering. Secondary outcomes include qualitative and quantitative antimicrobial use indicators, economic outcomes and clinical, microbiological and patient safety indicators.
Ethics approval was obtained for all participating sites (Comission Cantonale d'Éthique de la Recherche (CCER)2017-00454). The results of the trial will be submitted for publication in a peer-reviewed journal. Further dissemination activities will be presentations/posters at national and international conferences.
NCT03120975; Pre-results.
医院中抗菌药物的不当使用会导致抗菌药物耐药性。抗菌药物管理（AMS）干预旨在改善抗菌药物的处方，但通常需要大量资源和人员。计算机化决策支持系统（CDSSs）似乎是改善抗菌药物处方的一个有前景的工具，但在临床试验中尚未得到充分研究。
计算机化抗生素管理研究试验是一项由公共资金资助的、开放标签的、整群随机对照优势试验，旨在确定与“标准护理”AMS相比，集成在电子健康记录（EHR）中的多模式CDSS干预是否能减少瑞士两家二级和一家三级护理中心病房住院成年患者的总体抗生素暴露。将使用基于基线抗生素使用、专科和中心的“配对匹配”方法，将24个医院病房按1:1随机分为干预组或对照组。干预措施将包括：（1）针对选定适应症（基于适应症输入）的抗菌治疗选择和治疗持续时间的决策支持；（2）偏离当地指南（关于分子选择和持续时间）的可问责理由；（3）在抗菌治疗第4个日历日进行自我指导的治疗重新评估的警报；（4）每月病房层面的抗菌药物处方指标反馈。主要结局将是基于整个干预期（12个月）EHR中记录的给药数据，考虑到聚类情况，以每次入院治疗天数衡量的总体全身抗生素使用差异。次要结局包括定性和定量的抗菌药物使用指标、经济结局以及临床、微生物学和患者安全指标。
所有参与地点均获得了伦理批准（瑞士沃州研究伦理委员会（CCER）2017 - 00454）。试验结果将提交至同行评审期刊发表。进一步的传播活动将是在国内和国际会议上进行报告/展示海报。
NCT03120975；预结果。
