None listed
Conditions
Interventions
TR-701 FA 200 mg IV once daily for 7 days versus linezolid (Zyvox®) 600 mg IV every 12 hours for 10 days for the treatment of ventilated patients with presumed gram-positive HABP or VABP
Sponsors
Cubist Pharmaceuticals LLC.,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 • Empyema • Evidence of endocarditis • Tracheobronchitis
Countries
Arabia Saudi, Argentina, Australia, Austria, Belgium, Bosnial and Herzegovina, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Egypt, Estonia, France, Georgia, Germany, Greece, Guatemala, Hungary, Israel, Japan, Jordan, Kazakhstan, Korea South, Latovia, Lebano, Malasya, Mexico, New Zealand, Philippines, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United States
Contacts
Public ContactElizabeth Rospigliosi
INVENTIV HEALTH CLINICAL PERU S.A
Outcome results
None listed