A PHASE 3 RANDOMIZED DOBLE-BLIND STUDY COMPARING TR-701 FA AND LINEZOLID IN VENTILATED GRAM-POSITIVE NOSOCOMIAL PNEUMONIA

Cubist Pharmaceuticals LLC.,0 个研究点目标入组 4 人开始时间: 2014年4月16日最近更新: 2023年9月4日

试验速览

暂无简介。

•1.Males or females ≥18 years old
•2. Adequate venous access for IV study drug administration
•3. Intubated (via endotracheal tube, including tracheostomy patients) and mechanically ventilated, AND
•For HABP, at least 1 of the following signs or symptoms presenting within 24 hours prior to intubation of a patient hospitalized, including patients institutionalized in long-term care facilities, for ≥48 hours. If the patient has been discharged, discharge must have been within 7 days:
•o A new onset of cough (or worsening of baseline cough)
•o Dyspnea, tachypnea, or respiratory rate >30/minute, particularly if any or all of these signs or symptoms are progressive in nature
•o Hypoxemia (eg, a partial pressure of oxygen <60 mm Hg while the patient is breathing on room air as determined by arterial blood gas (ABG) or oxygen saturation <90% while the patient is breathing on
•room air as determined by pulse oximetry, or worsening (decline from any earlier finding) of the ratio of the partial pressure of oxygen to the fraction of inspired oxygen (PaO2/FiO2), or respiratory failure
•requiring mechanical ventilation
•For VABP, receiving mechanical ventilation ≥48 hours:
•Acute changes made in the ventilator support system to enhance oxygenation, as determined by ABG, or worsening PaO2/FiO2

•1. Known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia
•2. Any of the following health conditions:
•Legionella infection (Legionella pneumophila pneumonia)
•Cystic fibrosis
•Bronchiectasis
•Human immunodeficiency virus (HIV) infection with CD4 count
•<200 cell/mm³ (HIV testing is not required)
•Known or suspected Pneumocystitis jiroveci pneumonia
•Known or suspected active tuberculosis
•Lung abscess
•Evidence of endocarditis
•Tracheobronchitis

发起方