Clinical Study of 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

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.