Safety and Efficacy Study of Ceftaroline in Subjects With Staphylococcus Aureus Bacteremia or With Persistent Methicillin-Resistant Staphylococcus Aureus Bacteremia
NCT ID: NCT01701219
Last Updated: 2014-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
56 participants
INTERVENTIONAL
2013-01-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A
S. aureus on at least 1 blood culture within 72 hours of beginning study drug
Ceftaroline fosamil
Ceftaroline fosamil 600 mg intravenous (IV) infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) (dosing may be adjusted for renal function)
Cohort B
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
Ceftaroline fosamil
Ceftaroline fosamil 600 mg intravenous (IV) infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) (dosing may be adjusted for renal function)
Interventions
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Ceftaroline fosamil
Ceftaroline fosamil 600 mg intravenous (IV) infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) (dosing may be adjusted for renal function)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
2. Male or female ≥ 18 years of age.
3. 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.
4. Expectation of survival for at least 2 months.
Exclusion Criteria
2. 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.
3. Previous episode of S. aureus bacteremia within 3 months.
4. Known left-sided endocarditis or prosthetic heart valve.
5. Osteomyelitis or prosthetic joint infection except new onset nonhardware-associated vertebral osteomyelitis.
6. History of any hypersensitivity or allergic reaction to any β-lactam antibacterial agent.
7. Evidence of significant hepatic, hematologic, or immunologic impairment.
8. Pregnant or nursing females.
18 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Locations
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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
Investigational Site
Annandale, Virginia, United States
Investigational Site
Roanoke, Virginia, United States
Countries
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Related Links
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Sponsor Website
Other Identifiers
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CPT-MD-32
Identifier Type: -
Identifier Source: org_study_id