Cefiderocol Concentrations in the Lungs of Hospitalized Patients With Bacterial Pneumonia

Inclusion Criteria

• •1. Subject is 18 years or older at the time written informed consent is obtained
• •2. Subject has provided written informed consent or informed consent has been provided by subject's legally authorized representative
• •3. Subject has a diagnosis or suspicion of bacterial pneumonia (even if later known that the subject does not have bacterial pneumonia, discontinuation of the study is not necessary)
• •4. Subject is hospitalized and receiving standard of care antibiotic treatment for pneumonia
• •5. Subject is mechanically ventilated or expected to be mechanically ventilated at least 48 hours (or 72 hours for subjects with severe renal impairment) after the first dose of cefiderocol
• •6. Subject has a life expectancy of at least 3 weeks from the Screening visit
• •7. Subject is male (no contraception required) or female and meets 1 of the following criteria:
• •1. Surgically sterile (has had a hysterectomy and/or bilateral oophorectomy, or a bilateral salpingectomy or tubal ligation for the purpose of contraception for at least 6 weeks with appropriate documentation of such surgery)
• •2. Postmenopausal (defined as older than 45 years of age with cessation of regular menstrual periods for at least 6 months and a follicle-stimulating hormone level of \> 40 mIU/mL, or amenorrhea for at least 12 months)
• •3. Of childbearing potential and using combined (estrogen and progestogen) or progestogen-only hormonal contraception associated with inhibition of ovulation (including oral, intravaginal, injectable, implantable, and transdermal contraceptives), or an intrauterine device (IUD), or intrauterine hormone-releasing system for the entire duration of the study
• •4. Of childbearing potential and practicing abstinence as a preferred and usual life style and/or agrees to continue practicing abstinence from Screening for the entire duration of the study
• •5. Of childbearing potential and whose sole heterosexual partner has been successfully vasectomized and agrees to not have other heterosexual partners for the entire duration of the study