Cefiderocol Concentrations in the Lungs of Hospitalized Patients With Bacterial Pneumonia

Therapuetic Areas:Pulmonary / Respiratory Diseases
Age Range:18 - Any
Start Date:February 20, 2019
End Date:April 30, 2019
Contact:Shionogi Clinical Trials Administrator Clinical Support Help Line

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An Open-label Study to Assess the Intrapulmonary Concentrations of Cefiderocol at Steady State in Hospitalized Subjects With Bacterial Pneumonia on Treatment With Standard of Care Antibiotics and Requiring Mechanical Ventilation

The primary purpose of the study is to determine the degree of penetration of cefiderocol
into infected lung tissue in hospitalized adults with bacterial pneumonia who are being
mechanically ventilated.

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

4. Subject is hospitalized and receiving SOC 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

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

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from the study:

1. Subject has a chemical pneumonia that does not require antibiotic treatment (including
aspiration of gastric acid, inhalation injury). The term chemical pneumonia refers to
the aspiration of substances that are toxic to the lower airways causing chemical burn
and injuries in the airway.

2. Subject has a history of any moderate or severe hypersensitivity or allergic reaction
to any β-lactam (Note: for β-lactams, a history of a mild rash followed by uneventful
re-exposure is not a contraindication to enrollment)

3. Subject has extensive cystic lesion(s) or severe structural abnormality (eg, cystic
fibrosis, emphysema, cystic lesions of sarcoidosis or tuberculosis, postobstructive
pneumonia due to lung cancer, etc) of the lung that hinders recovery of
bronchoalveolar lavage fluid (BALF)

4. Subject is receiving peritoneal dialysis

5. Subject has severe renal impairment requiring hemodialysis (HD) or end-stage renal
disease requiring HD

6. Subject is in refractory septic shock defined as persistent hypotension despite
adequate fluid resuscitation or despite vasopressive therapy at Screening

7. Subject is a female who has a positive pregnancy test at Screening or who is lactating

8. Subject has received another investigational drug within 30 days prior to Screening

9. Subject has previously participated in this clinical study and has received at least 1
dose of cefiderocol within 7 days

10. Subject has any condition or circumstance that, in the opinion of the investigator,
would compromise the safety of the subject or the quality of the study data
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2500 California Plaza
Omaha, Nebraska 68102
(402) 280-2700
Creighton University Creighton University, located in Omaha, Neb., offers a top-ranked education in the Jesuit...
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Aurora, Colorado 80045
Aurora, CO
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Chicago, Illinois 60611
Chicago, IL
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
Hartford, CT
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Jacksonville, Florida 32209
Jacksonville, FL
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Miami, Florida 33136
Miami, FL
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New York, New York 10021
New York, NY
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