Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens

Inclusion Criteria

• •Subjects 18 years or older at the time of signing informed consent
• •Subjects who have provided written informed consent or their informed consent has been provided by a legally authorized representative
• •Subjects who meet the clinical diagnosis criteria for hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP)
• •All subjects must fulfill at least 1 of the following clinical criteria at screening:
• •1. New onset or worsening of pulmonary symptoms or signs, such as cough, dyspnea, tachypnea (eg, respiratory rate \> 25 breaths/minute), expectorated sputum production, or requirement for mechanical ventilation
• •2. Hypoxemia (eg, a partial pressure of oxygen \[PaO2\] \< 60 mm Hg while the subject is breathing room air, as determined by arterial blood gas \[ABG\], or worsening of the ratio of the PaO2 to the fraction of inspired oxygen \[PaO2/FiO2\])
• •3. Need for acute changes in the ventilator support system to enhance oxygenation, as determined by worsening oxygenation (ABG or PaO2/FiO2) or needed changes in the amount of positive end-expiratory pressure
• •4. New onset of or increase in (quantity or characteristics) suctioned respiratory secretions, demonstrating evidence of inflammation and absence of contamination
• •All subjects must have at least 1 of the following signs:
• •1. Documented fever (ie, core body temperature \[tympanic, rectal, esophageal\] ≥ 38°C \[100.4°F\], oral temperature ≥ 37.5°C, or axillary temperature ≥ 37°C)
• •2. Hypothermia (ie, core body temperature \[tympanic, rectal, esophageal\] ≤ 35°C \[95.0°F\], oral temperature ≤ 35.5°C and axillary temperature ≤ 36°C)
• •3. Leukocytosis with a total peripheral white blood cell (WBC) count ≥ 10,000 cells/mm³
• •4. Leukopenia with total peripheral WBC count ≤ 4500 cells/mm³
• •5. Greater than 15% immature neutrophils (bands) noted on peripheral blood smear
• •All subjects must have a chest radiograph during screening showing the presence of new or progressive infiltrate(s) suggestive of bacterial pneumonia. A computed tomography (CT) scan in the same time window showing the same findings could also be acceptable
• •All subjects must have a suspected Gram-negative infection involving the lower respiratory tract