PROARRAY : Impact on PCT+ FilmArray RP2 Plus Use in LRTI Suspicion in Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioMérieux
- 入组人数
- 444
- 试验地点
- 1
- 主要终点
- Duration of total antibiotic exposure
研究概览
简要总结
The real-time reporting of PCT results along with viral PCR data from the FilmArray® Respiratory Panel 2 plus in conjunction with an antimicrobial stewardship plan will aid in the proper withholding or withdrawing of antibiotics (ATB) when the collective data is indicative of a viral Lower Respiratory Tract Infection (LRTI).
The addition of the FilmArray® RP2plus diagnostic test indicating the presence of a viral infection in subjects presenting with respiratory symptoms could improve the confidence to care-providing physicians to withhold prescribing antibiotics.
详细描述
In the emergency room a nasopharyngeal swab sample will be collected from subjects with a suspected LRTI for the FilmArray respiratory panel assay plus a blood sample for the PCT assay if the PCT measurement has not been already prescribed.
The FilmArray® Respiratory Panel 2 plus (RP2plus) is a multiplexed nucleic acid test intended for use with FilmArray® 2.0 or FilmArray® Torch systems for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infections.
Both results will be reported in real-time to the treating physicians with the recommendation to withhold or withdraw antibiotics if:
- PCT<0.10 µg/L with either a positive (with a viral respiratory pathogen) or negative FilmArray assay or
- PCT<0.25 µg/L and FilmArray positive with a viral respiratory pathogen. For the control arm, patients will benefit from the usual care of patients with suspected LRTI at the discretion of the attending physician. Care may entail a CRP and/or a PCT measurement, but no nasopharyngeal swab sampling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥ 18 years of age attending the ED with LRTI symptom defined as at least one among:
- •sweats, chills, body aches and pain, temperature >38°C) and at least one among:
- •cough, sputum production, dyspnea, chest pain, altered breath sounds at auscultation.
- •Subject signs informed consent
排除标准
- •Subject is a prisoner
- •Subject is a Pregnant
- •Subject has no social insurance
- •Subject is enrolled in end of life care
- •Subject refuses to participate in study procedures
- •Subject is already enrolled (each patient will only be tested one time with the FilmArray® RP2plus)
- •Subject has a contraindication (per the discretion of the attending physician) to a nasopharyngeal swab (for example, nose bone fracture or recent history of maxilla-facial surgery)
结局指标
主要结局
Duration of total antibiotic exposure
时间窗: First 28 days
The primary endpoint in this study is the duration of total antibiotic exposure (measured in days) in the first 28 days after randomization.
次要结局
- Protocol "failure" within 15 days of randomization(within 15 days)
- Initiation of an antibiotic therapy(First 28 days)