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

Completed · Phase 3

Conditions studied: Healthcare-associated Pneumonia (HCAP), Hospital Acquired Pneumonia (HAP), Ventilator Associated Pneumonia (VAP)

In brief

The primary objective of this study is to compare all-cause mortality at Day 14 in participants receiving cefiderocol with participants receiving the comparator, meropenem, in adults with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP) caused by Gram-negative pathogens.

Key facts

Study ID

NCT03032380

Run by

Shionogi

People needed

300

Starts

2017-10-24

Expected to finish

2019-04-01

Last updated by the study team

2020-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Shionogi Research Site — DeLand, Florida, United States
• Shionogi Research Site — Chicago, Illinois, United States
• Shionogi Research Site — Council Bluffs, Iowa, United States
• Shionogi Research Site — Louisville, Kentucky, United States
• Shionogi Research Site — Baton Rouge, Louisiana, United States
• Shionogi Research Site — Shreveport, Louisiana, United States
• Shionogi Research Site — Annapolis, Maryland, United States
• Shionogi Research Site — Detroit, Michigan, United States
• Shionogi Research Site — St Louis, Missouri, United States
• Shionogi Research Site — Cleveland, Ohio, United States
• Shionogi Research Site — Columbus, Ohio, United States
• Shionogi Research Site — Bethlehem, Pennsylvania, United States
• Shionogi Research Site — Philadelphia, Pennsylvania, United States
• Shionogi Research Site — Salt Lake City, Utah, United States
• Shionogi Research Site — Brussels, Belgium
• Shionogi Research Site — Brussels, Belgium
• Shionogi Research Site — Halifax, Nova Scotia, Canada
• Shionogi Research Site — Kingston, Ontario, Canada
• Shionogi Research Site — Brno, Czechia
• Shionogi Research Site — Hradec Králové, Czechia
• Shionogi Research Site — Kolín, Czechia
• Shionogi Research Site — Kyjov, Czechia
• Shionogi Research Site — Ostrava-Poruba, Czechia
• Shionogi Research Site — Prague, Czechia
• Shionogi Research Site — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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