Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus

Completed · Phase 4

Conditions studied: Infections

In brief

The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant Staphylococcus aureus (MRSA).

Key facts

Study ID

NCT01645735

Run by

Forest Laboratories

People needed

49

Starts

2012-10-01

Expected to finish

2013-12-01

Last updated by the study team

2016-02-01

Who can join

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

You may qualify if…

• Subjects are required to meet All of the following inclusion criteria:
• Male or female, ≥ 18 years old
• Presence of CABP requiring hospitalization
• Presence of CABP meeting the following criteria:
• I. confirmed pneumonia (new or progressive pulmonary) II. Acute illness (≤ 7 days' duration) with at least 3 clinical signs or symptoms consistent with a lower respiratory tract infection
• MRSA Risk Factors
• MRSA-positive blood culture or respiratory specimen or a risk factor for MRSA such as a history of colonization with MRSA

You may not qualify if…

• Subjects must Not meet any of the following exclusion criteria at baseline:
• History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial
• Suspected or microbiologically-documented infection with a pathogen known to be resistant to any of the study drugs
• Non-infectious causes of pulmonary infiltrates (eg, pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
• More than 24 hours of potentially effective systemic antibacterial therapy for CABP within 96 hours before randomization
• End-stage renal disease [Creatinine Clearance (CrCl) < 15], including hemodialysis
• Evidence of significant hepatic, hematological, or immunocompromising condition

Where it is running

• Investigational Site — Phoenix, Arizona, United States
• Investigational Site — Sylmar, California, United States
• Investigational Site — DeLand, Florida, United States
• Investigational Site — Chicago, Illinois, United States
• Investigational Site — Kansas City, Kansas, United States
• Investigational Site — Royal Oak, Michigan, United States
• Investigational Site — Minneapolis, Minnesota, United States
• Investigational Site — St Louis, Missouri, United States
• Investigational Site — Omaha, Nebraska, United States
• Investigational Site — Laconia, New Hampshire, United States
• Investigational Site — Columbus, Ohio, United States
• Investigational Site — Lima, Ohio, United States
• Investigational Site — Oklahoma City, Oklahoma, United States
• Investigational Site — Tbilisi, Georgia
• Investigational Site — Mátraháza, Hungary
• Investigational Site — Lodz, Poland
• Investigational Site — Lublin, Poland
• Investigational Site — Wilkowice-Bystra, Poland
• Investigational Site — Craiova, Dolj, Romania
• Investigational Site — Bucharest, Romania
• Investigational Site — Iași, Romania
• Investigational Site — Moscow, Russia
• Investigational Site — Saint Petersburg, Russia
• Investigational Site — Yaroslavl, Russia
• Investigational Site — Alicante, Spain

Full record on ClinicalTrials.gov

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