Clinical Study of Cefiderocol (S-649266) for the Treatment of Nosocomial Pneumonia Caused by Gram-negative Pathogens (APEKS-NP)
Healthcare-associated Pneumonia (HCAP), Hospital Acquired Pneumonia (HAP), Ventilator Associated Pneumonia (VAP)
About this trial
This is an interventional treatment trial for Healthcare-associated Pneumonia (HCAP) focused on measuring Hospital-acquired pneumonia (HAP), S-649266, linezolid, meropenem, Healthcare-associated pneumonia (HCAP), nosocomial pneumonia, Ventilator-associated pneumonia (VAP), Gram-negative pathogens, pneumonia, cefiderocol
Eligibility Criteria
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:
- 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
- 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])
- 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
- 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:
- Documented fever (ie, core body temperature [tympanic, rectal, esophageal] ≥ 38°C [100.4°F], oral temperature ≥ 37.5°C, or axillary temperature ≥ 37°C)
- Hypothermia (ie, core body temperature [tympanic, rectal, esophageal] ≤ 35°C [95.0°F], oral temperature ≤ 35.5°C and axillary temperature ≤ 36°C)
- Leukocytosis with a total peripheral white blood cell (WBC) count ≥ 10,000 cells/mm³
- Leukopenia with total peripheral WBC count ≤ 4500 cells/mm³
- 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
Exclusion Criteria:
- Subjects who have known or suspected community-acquired bacterial pneumonia (CABP), atypical pneumonia, viral pneumonia, or chemical pneumonia (including aspiration of gastric contents, inhalation injury)
- Other exclusions based on the prescribing information of meropenem or linezolid, prior antibiotic usage, age, and pregnancy.
Sites / Locations
- Shionogi Research Site
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Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Cefiderocol
Meropenem
Participants will receive 2 g cefiderocol administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.
Participants will receive 2 g meropenem administered intravenously every 8 hours for 7 to 14 days and 600 mg linezolid administered intravenously every 12 hours for at least 5 days.