A Clinically-Oriented Antimicrobial Resistance Surveillance Network for Healthcare-associated infections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15,000
- 试验地点
- 3
- 主要终点
- Incidence & prevalence of multidrug resistant organisms (MDRO) in HA-BSI or VAP quantified in terms of i) hospitalisation, ii) patient bed-days & iii) microbiology cultures
研究概览
简要总结
A Clinically-Oriented Antimicrobial ResistanceSurveillance Network (ACORN) isa large-scale multicentre study which expands on the WHO Global AntimicrobialResistance Surveillance System to estimate syndromic and pathogen outcomesalong with associated health economic costs. It aims to implement an efficientclinically-oriented AMR surveillance system, incorporated as part of routineworkflow in hospitals in low- and middle-income country settings (LMICs). LMICshold the highest burdens of AMR and are responsible for the increasing trend inantibiotic consumption globally.High-quality patient-level surveillance data from LMICs are necessary todetermine the impact of AMR, enable evaluation of interventions, inform policydecisions on resource allocation, and drive research priorities. The ACORN studyinvolves various clinical units including intensive care units (ICUs) at eachsite. Patients with community-acquired infections are expected to form themajority of the enrolment.
Implementation of a robust surveillance network for HAIscaused by MDROs is the necessary first step towards designing infectionprevention and control policies, guiding resource allocation, and motivatingnovel treatment therapy clinical trials. A focus on severe HAIs with thehighest health and economic consequences will align the interests andexpectations from various stakeholders including patients, clinicians, healthministries and pharmaceutical industry. Such data will engage all parties todirect a concerted effort to tackle the urgent issues in AMR.
This is a large-scale multicentrestudy for surveillance of HA-BSI and VAP, with a focus on LMICs.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthcare-associated bloodstream infection 1) Prescription/commencement of an intravenous antibiotic AND 2) Positive growth of bacterial or Candida spp pathogen(s) identified from blood specimen(s) taken on or after day 3 of admission (Day 1 refers to the day of admission), or within 3 months of significant healthcare exposure; AND 3) Bacterial pathogen(s) in the blood specimen(s) satisfies either of the following: i) one or more non-common commensal bacterial pathogen(s) identified from one or more blood specimens obtained by a culture; OR ii) the same common commensal bacterial pathogen identified from two or more blood specimens collected on separate occasions Ventilator-associated pneumonia 1) Clinical suspicion of VAP; AND 2) Prescription/commencement of an intravenous antibiotic; AND 3) Positive growth of bacterial pathogen(s) identified from respiratory specimen(s) taken on or after day 3 of ventilation.
排除标准
- •Healthcare-associated bloodstream infection Patient who has positive growth of organisms belonging to the following genera which are typically causes of community-associated infections and are rarely or are not known to be causes of healthcare-associated infections, or associated with severe immune suppression: a)Burkholderia pseudomallei, b)Brucella spp, including but not limited to, B.
- •melitensis, B.
- •canis, c)Campylobacter, Salmonella, Shigella, Listeria, Vibrio and Yersinia.
- •Ventilator-associated pneumonia Patient who has positive growth of organisms belonging to the following genera which are typically causes of community-associated infections and/or are rarely or are not known to be causes of healthcare-associated infections: a)Streptococcus pneumoniae, Streptococcus suis, Haemophilus influenzae, b)Burkholderia pseudomallei, c)Coagulase-negative staphylococci, d)Talaromyces marneffei, e)Mycobacterium Tuberculosis, f)Rapidly growing Mycobacteria, including but not limited to, M.
- •mucogenicum, M.
- •fortuitum, M.
- •abscessus, M.
- •chelonae, M.
结局指标
主要结局
Incidence & prevalence of multidrug resistant organisms (MDRO) in HA-BSI or VAP quantified in terms of i) hospitalisation, ii) patient bed-days & iii) microbiology cultures
时间窗: Onset of clinical syndrome is on or after day 3 of hospital admission, or within 3 months of significant healthcare exposure.
次要结局
- Severity of disease (requirement for intensive care, duration of hospitalisation, functional status at discharge, mortality), types of antibiotic treatment(28 days from onset of the last infection episode)
- Attributable mortality of HA-BSI or VAP caused by MDROs versus susceptible organisms or MDROs of different resistance patterns(All-cause mortality of HA-BSI or VAP)
- Bacterial species & phenotypic resistance patterns across the study sites from various geographical regions over the study period.(Over the study period)
- Genomic characteristics in terms of bacterial strains/clones, resistance genes across the study sites from various geographical regions(Over the study period)