NCT04193878终止3 期
ARrest RESpiraTory Failure From PNEUMONIA (ARREST PNEUMONIA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 465
- 试验地点
- 21
- 主要终点
- Acute respiratory failure (ARF)
研究概览
简要总结
This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Patients 18 years or older with
- •Severe pneumonia defined as:
- •1. Hospitalization for acute (defined as ≤ 14 days) onset of symptoms (cough, sputum production, or dyspnea), AND
- •Radiographic evidence of pneumonia by chest radiograph or CT scan, AND
- •One of the following:
- •Evidence of systemic inflammation (temperature < 35◦C or > 38◦C OR WBC > or < upper or lower limits for site OR procalcitonin > 0.5 mcg/L), OR
- •Known current immunosuppression preventing inflammatory response, OR
- •High clinical suspicion of pneumonia with microbiologic confirmation of infection. Microbiologic confirmation will include a positive nasal swab for a known respiratory virus; a sputum culture growing a likely pathogenic organism plus moderate or greater WBCs (not required for immunocompromised patients); or a positive blood culture with a likely pathogenic organism - e.g., ¼ vials with S. Epidermidis would NOT qualify)
- •AND Hypoxemia defined as new requirement for daytime supplemental oxygen with SpO2 < 92% on room air, ≤ 96% on ≥ 2 L/min oxygen, or > 6L/min or non-invasive ventilation regardless of SpO2 at enrollment. Patients admitted with pneumonia but not meeting criteria for hypoxemia will be followed for up to 48 hours from ED admission to enrolling hospital to assess for development of qualifying hypoxemia.
排除标准
- •Inability to randomize within 48 hours of presentation to enrolling hospital (randomization beyond 24 hours will be limited to patients with persistent hypoxemia defined by an SpO2 < 97% while on > 3L/min O2)
- •Intubation (or impending intubation) prior to enrollment
- •a. Patients receiving HFNC oxygen or NIV prior to enrollment are not excluded
- •A condition requiring inhaled corticosteroids or beta-agonists (patients receiving inhaled beta-agonists in the ED without an established indication will be eligible if treating clinician is willing to discontinue subsequent treatments)
- •Chronic systemic steroid therapy equivalent to >10 mg prednisone
- •COVID-19 positive patients receiving > 6 mg dexamethasone (40 mg prednisone equivalent dose) except for stress dose steroids for septic shock
- •Non-COVID-19 pneumonia patients receiving systemic steroid > 10 mg prednisone except for stress dose steroids for septic shock
- •Chronic lung or neuromuscular disease requiring daytime oxygen or mechanical ventilation other than for obstructive sleep apnea (OSA) or obesity hypoventilation syndrome
- •Not anticipated to survive > 48 hours or not expected to require > 48 hours of hospitalization
- •Contraindication or allergy to inhaled corticosteroids or beta-agonists
- •Patients with heart rate > 130 bpm, ventricular tachycardia or new supraventricular tachycardia within last 4 hours will be potentially eligible for enrollment after the condition has resolved
- •Patients with K+ < 3.0 will be potentially eligible for enrollment after the condition has resolved
- •Patient not committed to full support other than intubation or resuscitation (i.e., DNR/DNI status allowed)
- •Pregnancy
- •Incarcerated individual
- •Physician refusal of consent to protocol
- •Patient/surrogate refusal of consent to protocol
研究组 & 干预措施
Placebo
Placebo Comparator
4 ml aerosolized 0.9% saline every 12 hours x 10 doses
干预措施: Inhaled placebo (Drug)
Intervention
Active Comparator
aerosolized formoterol (20 mcg/2 ml) and budesonide (1.0 mg/2 ml) every 12 hours x 10 doses
干预措施: Inhaled budesonide and formoterol (Drug)
结局指标
主要结局
Acute respiratory failure (ARF)
时间窗: within 7 days of randomization
High flow nasal cannula (HFNC \>=20L/mon O2) and/or Noninvasive ventilation (NIV) use for greater than 36 hours OR Invasive mechanical ventilation for greater than 36 hours OR Death in a patient placed on respiratory support (HFNC, NIV, ventilator) who dies before 36 hours
Acute Respiratory Failure (ARF)
时间窗: within 7 days of randomization (day 0)
High flow nasal cannula (HFNC \>=20L/mon O2) and/or Noninvasive ventilation (NIV) use for greater than 36 hours OR Invasive mechanical ventilation for greater than 36 hours OR Death in a patient placed on respiratory support (HFNC, NIV, ventilator) who dies before 36 hours
次要结局
- Hospital length of stay(within 60 days of randomization)
- Oxygen failure free days to day 28(Until Day 28)
- Proportion of patients intubated for respiratory failure(Within 7 days of randomization)
- Duration of need for supplemental oxygen(within 30 days of randomization)
- Progression to systemic steroid therapy for pneumonia(during course of the study)
- Hospital Length of Stay(within 60 days of randomization (day 0))
- Duration of Need for Supplemental Oxygen(within 30 days of randomization (day 0))
- Proportion of Patients Intubated for Respiratory Failure(Within 7 days of randomization (day 0))
- Oxygen Failure Free Days to Day 28(Until Day 28)
- Progression to Systemic Steroid Therapy for Pneumonia(Within 7 days of randomization (day 0))
研究者
Joseph Levitt, MD
Clinical Assistant Professor
Stanford University
研究点 (21)
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