Last updated on April 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hospital Acquired Pneumonia | Ventilator associated pneumonia | Hospital Acquired Pneumonia (HAP) | Healthcare-associated Pneumonia (HCAP)
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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] 38C [100.4F], oral temperature 37.5C, or axillary temperature 37C)
    2. Hypothermia (ie, core body temperature [tympanic, rectal, esophageal] 35C [95.0F], oral temperature 35.5C and axillary temperature 36C)
    3. Leukocytosis with a total peripheral white blood cell (WBC) count 10,000 cells/mm
    4. Leukopenia with total peripheral WBC count 4500 cells/mm
    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.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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