Safety and Efficacy Study of Ceftaroline in Subjects With Staphylococcus Aureus Bacteremia or With Persistent Methicillin-Resistant Staphylococcus Aureus Bacteremia

Completed · Phase 4

Conditions studied: Staphylococcus Aureus Bacteremia, Methicillin-resistant Staphylococcus Aureus (MRSA) Bacteremia

In brief

This is a study of safety and efficacy of ceftaroline fosamil in Subjects with Staphylococcus aureus Bacteremia or with Methicillin-Resistant Staphylococcus aureus (MRSA) Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment.

Key facts

Study ID

NCT01701219

Run by

Forest Laboratories

People needed

56

Starts

2013-01-01

Expected to finish

2014-07-01

Last updated by the study team

2014-07-31

Who can join

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

You may qualify if…

• Presence of bacteremia due solely to:
• S. aureus on at least 1 blood culture within 72 hours of beginning study drug (Cohort A) OR
• MRSA on a baseline blood culture and on at least 1 additional blood culture after at least 72 hours of vancomycin and/or daptomycin treatment (Cohort B).
• Male or female ≥ 18 years of age.
• If female of childbearing potential must be willing to practice sexual abstinence or dual methods of contraception during treatment and for at least 30 days after the last dose of study drug.
• Expectation of survival for at least 2 months.

You may not qualify if…

• For subjects in Cohort A: previous therapy for more than 48 hours with any parenteral antibiotic with activity against S. aureus within 72 hours of positive blood culture results.
• For subjects in Cohort B: previous therapy for more than 48 hours with any parenteral antibiotic with activity against MRSA, except vancomycin and/or daptomycin, within 72 hours of positive blood culture results confirming persistence.
• Previous episode of S. aureus bacteremia within 3 months.
• Known left-sided endocarditis or prosthetic heart valve.
• Osteomyelitis or prosthetic joint infection except new onset nonhardware-associated vertebral osteomyelitis.
• History of any hypersensitivity or allergic reaction to any β-lactam antibacterial agent.
• Evidence of significant hepatic, hematologic, or immunologic impairment.
• Pregnant or nursing females.

Where it is running

• Investigational Site — Birmingham, Alabama, United States
• Investigational Site — Sacramento, California, United States
• Investigational Site — San Francisco, California, United States
• Investigational Site — Sylmar, California, United States
• Investigational Site — Torrance, California, United States
• Investigational Site — Hartford, Connecticut, United States
• Investigational Site — Pensacola, Florida, United States
• Investigational Site — Stuart, Florida, United States
• Investigational Site — Decatur, Georgia, United States
• Investigational Site — Macon, Georgia, United States
• Investigational Site — Chicago, Illinois, United States
• Investigational Site — Fort Wayne, Indiana, United States
• Investigational Site — Louisville, Kentucky, United States
• Investigational Site — Boston, Massachusetts, United States
• Investigational Site — Detroit, Michigan, United States
• Investigational Site — Detroit, Michigan, United States
• Investigational Site — Grosse Pointe Woods, Michigan, United States
• Investigational Site — Royal Oak, Michigan, United States
• Investigational Site — Laconia, New Hampshire, United States
• Investigational Site — Neptune City, New Jersey, United States
• Investigational Site — Newark, New Jersey, United States
• Investigational Site — Jamaica, New York, United States
• Investigational Site — Toledo, Ohio, United States
• Investigational Site — Greenville, South Carolina, United States
• Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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