EUCTR2013-004154-22-IT进行中（未招募）1 期
A Phase 3 Randomized Double-blind Study Comparing TR-701 FA and Linezolid in Ventilated Gram-positive Nosocomial Pneumonia - TR701-132
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 726
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients who meet all the following diagnostic and inclusion criteria are
- •eligible for the study.
- •1. Males or females = 18 years old
- •2. Adequate venous access for IV study drug administration
- •3. Intubated (via endotracheal tube, including tracheostomy patients)
- •XML File Identifier: Q8pjY7iOcLQVtt1rOFWxPDzqpy4=
- •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
- •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
- •4. Chest radiograph shows the presence of new or progressive
- •infiltrate(s) suggestive of bacterial pneumonia (based on Investigator
- •evaluation; report from qualified medical professional who is not the
- •Investigator to be provided) 5. Clinical findings to support diagnosis of HABP/VABP
- •New onset of suctioned respiratory secretions characterized by
- •purulent appearance indicative of bacterial pneumonia
- •And at least 1 of the following:
- •o Documented fever (oral =38°C [100.4°F] or a tympanic, temporal,
- •rectal, or core temperature =38.3°C [101°F]) OR
- •o Hypothermia (core body temperature =35°C [95.2°F]) OR
- •o Total peripheral white blood cell (WBC) count =10,000 cells/mm3 OR
- •o Leukopenia with total WBC =4500 cells/mm3 OR
- •o =15% immature neutrophils (bands; if local laboratory has
- •capabilities to measure)
- •6. High probability of pneumonia caused by gram-positive cocci only or
- •in a mixed infection defined as follows:
- •Respiratory Sample
- •o Sample acquired and Gram stain performed within 24 hours prior to
- •first infusion of study drug using an acceptable purulent respiratory
- •specimen such as sputum or endotracheal aspirate sample with <10
- •squamous epithelial cells (SEC) per low-power field and more than 25
- •polymorphonuclear cells per low-power field showing gram-posit
排除标准
- •Patients who meet any of the following criteria are not eligible to
- •participate in this study:
- •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 last known 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 (if no evidence of pneumonia)
- •3. Received systemic or inhaled antibiotic therapy effective for grampositive
- •pathogens that cause VNP for >24 hours (for example, >1 dose
- •of a once-daily antibiotic, >2 doses of a twice daily antibiotic) in the last
- •Progression of disease on the prior antibacterial regimen for this
- •episode of VNP after >48 hours of treatment; requires microbiological
- •confirmation of a gram-positive pathogen,
- •Patient developed symptoms of pneumonia and a new infiltrate while
- •receiving the prior antibacterial regimen for reasons other than the
- •current VNP,
- •Patient received systemic antibacterial therapy that does not cover the
- •gram positive pathogen isolated on respiratory culture,
- •Antibiotic therapy for gut decontamination or gut motility (example,
- •low-dose erythromycin) or C. difficile infection
- •4. Receipt of monoamine oxidase A and B inhibitors (see Appendix 1)
- •from 2 weeks prior to randomization or planned use through the End of
- •Therapy (EOT) Visit
- •5. Planned use of agents with serotonergic activity (see Appendix 1 and
- •Section 1.4) through the EOT Visit
- •6. Administration of linezolid or tedizolid phosphate =30 days before the
- •first infusion of study drug, except for receipt of a single administration
- •of linezolid, within 24 hours prior to the first administration of study
- •drug to treat the current VNP.
- •7. Bronchial obstruction or a history of postobstructive pneumonia (this
- •does not exclude patients with pneumonia who have underlying chronic
- •obstructive pulmonary disease)
- •8. Primary lung cancer or another malignancy metastatic to the lungs
- •9. Recent opportunistic infections where the underlying cause of the
- •infection is still active (eg, leukemia, transplant, acquired
- •immunodeficiency syndrome) 10. Expected survival <72 hours or any 1 of the following:
- •Comfort care measures only
- •Acute respiratory distress syndrome/acute lung injury secondary to
- •septic shock, or due to third degree burns or inhalation injury
- •Nonresolving pulmonary edema secondary to c
研究者
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