ISRCTN65693049进行中（未招募）未知
Pragmatic randomized controlled trial of molecular point-of-care testing for respiratory pathogens versus routine clinical care in critically ill adults with Pneumonia: SARIPOC
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
2022 Results article in https://doi.org/10.1016/j.jinf.2022.09.003 (added 30/09/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 12/02/2020:
- •1. Admitted to the Respiratory High Dependency Unit (RHDU), or an Intensive Care Unit (ICU), or about to be transferred to RHDU, GICU, NICU or under the care of the RHDU or ICU team in another hospital area, within University Hospital Southampton NHS Foundation Trust (UHS)
- •2. Aged =18 years
- •3. Has a working diagnosis of CAP, HAP or VAP* and physician decides to start new antibiotic treatment or modify existing antibiotic treatment.
- •*CAP defined by the BTS as: ‘symptoms and signs of acute lower respiratory tract infection associated with new radiographic shadowing for which there is no other explanation’. CAP patients who are intubated and ventilated remain classified as CAP.
- •HAP defined as by the IDSA as: ‘new lung infiltrate, plus clinical evidence that the infiltrate is of an infectious origin, which includes the new onset of fever, purulent sputum, leucocytosis, and decline in oxygenation... arising >48 h after hospital admission’. HAP patients who are intubated and ventilated remain classified as HAP.
- •VAP defined as by the IDSA as: ‘new lung infiltrate plus clinical evidence that the infiltrate is of an infectious origin, which include the new onset of fever, purulent sputum, leucocytosis, and decline in oxygenation... occurring >48 h after endotracheal intubation’
- •Previous participant inclusion criteria:
- •1. Admitted to the Respiratory High Dependency Unit (RHDU), or an Intensive Care Unit (ICU), or about to be transferred to either RHDU or ICU, or under the care of the RHDU or ICU team in another hospital area, within University Hospital Southampton NHS Foundation Trust (UHS)
- •2. Aged =18 years old
- •3. Duration of respiratory illness less than 10 days prior to hospitalisation
- •4. Presented to hospital less than 72 hours prior to enrolment
- •5. Has a severe acute respiratory illness*
- •*An episode of severe acute respiratory illness is defined as an acute pulmonary illness (including pneumonia, bronchitis and influenza-like illness) or an acute exacerbation of a chronic respiratory illness (including exacerbation of COPD, asthma or bronchiectasis), requiring high dependency or intensive care. For the study, a severe acute respiratory illness as a provisional, working, differential or confirmed diagnosis must be made by a treating clinician.
排除标准
- •Current participant exclusion criteria as of 12/02/2020:
- •1. A purely palliative approach being taken by the treating clinicians
- •2. Previously included in this study
- •3. Consent declined or consultee consent declined
- •4. Underlying Cystic Fibrosis or other condition characterized by persistent colonization with resistant organisms
- •5. Not expected to survive the next 24 h in the opinion of the responsible clinical team
- •Involvement in observational trials may not exclude a participant from this trial, and this is at the CI’s discretion.
- •Previous participant exclusion criteria:
- •1. Not fulfilling all the inclusion criteria
- •2. A purely palliative approach being taken by the treating clinicians
- •3. Previously included in this study
- •4. Declines nasal / pharyngeal swabbing
- •5. Consent declined or consultee consent declined
- •6. Severe acute respiratory illness is related to solely to critical illness and/or is not the principal illness leading to ICU/HDU admission
研究者
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