Clinical trial NCT03032380 (phase 3, status: completed)
Conditions: healthcare-associated pneumonia (hcap), hospital acquired pneumonia (hap), ventilator associated pneumonia (vap)
ICD codes: A01.03, A02.22, A54.84, B01.2, B06.81, B77.81, J12.0, A01.03, A02.22, A54.84, B01.2, B06.81, B77.81, J12.0, J95.851, J95.859, Z99.11, Z99.12
Drugs: cefiderocol, meropenem, linezolid
SMILES: CN(C)CCOC(C)(C1=CC=CC=C1)C1=CC=CC=N1, CC(=O)NC[C@H]1CN(C(=O)O1)C1=CC(F)=C(C=C1)N1CCOCC1
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:

               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

        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.