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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01701219
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : July 31, 2014
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Staphylococcus Aureus Bacteremia Methicillin-resistant Staphylococcus Aureus (MRSA) Bacteremia Drug: Ceftaroline fosamil Phase 4

Detailed Description:
Subjects with either S. aureus bacteremia or persistent MRSA bacteremia will be treated with open label ceftaroline fosamil, safety will be monitored and clearance of bacteremia will be evaluated.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, 2-Cohort Study to Describe the Safety and Efficacy of Ceftaroline Fosamil in Subjects With Staphylococcus Aureus Bacteremia or With Persistent Methicillin-Resistant Staphylococcus Aureus Bacteremia
Study Start Date : January 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRSA

Arms and Interventions
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Arm Intervention/treatment
Cohort A
S. aureus on at least 1 blood culture within 72 hours of beginning study drug
 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)
Other Names:
  • Teflaro®
  • PPI-0903
  • TAK-599
  • TAK599
  • PPI0903
  • Zinforo
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
 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)
Other Names:
  • Teflaro®
  • PPI-0903
  • TAK-599
  • TAK599
  • PPI0903
  • Zinforo


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the safety of ceftaroline fosamil in adult Subjects (≥ 18 years of age) with Staphylococcus aureus Bacteremia or with MRSA Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment [ Time Frame: 60 days following completion of antibacterial therapy and discharge from the hospital, anticipated between 74 to 119 days ]

    Efficacy outcome measures:

    • Time to clearance of bacteremia
    • Time to defervescence
    • Clinical outcome
    • Mortality
    • Readmission


Secondary Outcome Measures :
  1. Evaluate the efficacy of ceftaroline fosamil in adult Subjects (≥ 18 years of age) with Staphylococcus aureus Bacteremia or with MRSA Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment [ Time Frame: Between 3 and 119 days ]

    Safety evaluations will be conducted and assessments will include:

    • Adverse events including deaths will be evaluated
    • Laboratory: complete blood count (CBC) with differential and chemistry panel


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  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:

  1. 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.
  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701219


Locations
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United States, Alabama
Investigational Site
Birmingham, Alabama, United States, 35294
United States, California
Investigational Site
Sacramento, California, United States, 95817
Investigational Site
San Francisco, California, United States, 94110
Investigational Site
Sylmar, California, United States, 91342
Investigational Site
Torrance, California, United States, 90502
United States, Connecticut
Investigational Site
Hartford, Connecticut, United States, 06102
United States, Florida
Investigational Site
Pensacola, Florida, United States, 32504
Investigational Site
Stuart, Florida, United States, 34994
United States, Georgia
Investigational Site
Decatur, Georgia, United States, 30030
Investigational Site
Macon, Georgia, United States, 31201
United States, Illinois
Investigational Site
Chicago, Illinois, United States, 60612
United States, Indiana
Investigational Site
Fort Wayne, Indiana, United States, 46845
United States, Kentucky
Investigational Site
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Investigational Site
Boston, Massachusetts, United States, 02111
United States, Michigan
Investigational Site
Detroit, Michigan, United States, 48201
Investigational Site
Detroit, Michigan, United States, 48202
Investigational Site
Grosse Pointe Woods, Michigan, United States, 48236
Investigational Site
Royal Oak, Michigan, United States, 48073
United States, New Hampshire
Investigational Site
Laconia, New Hampshire, United States, 03246
United States, New Jersey
Investigational Site
Neptune, New Jersey, United States, 07753
Investigational Site
Newark, New Jersey, United States, 07102
United States, New York
Investigational Site
Jamaica, New York, United States, 11418
United States, Ohio
Investigational Site
Toledo, Ohio, United States, 43620
United States, South Carolina
Investigational Site
Greenville, South Carolina, United States, 29605
United States, Texas
Investigational Site
Houston, Texas, United States, 77030
United States, Virginia
Investigational Site
Annandale, Virginia, United States, 22003
Investigational Site
Roanoke, Virginia, United States, 24014
Sponsors and Collaborators
Forest Laboratories
More Information
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Additional Information:

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Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01701219    
Other Study ID Numbers: CPT-MD-32
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: July 2014
Keywords provided by Forest Laboratories:
Staphylococcus aureus bacteremia
Methicillin-resistant Staphylococcus aureus bacteremia
MRSA bacteremia
Blood
 Adult
Infections
Blood Culture
Additional relevant MeSH terms:
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Bacteremia
Staphylococcal Infections
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
Gram-Positive Bacterial Infections
Ceftaroline fosamil
Anti-Bacterial Agents
Anti-Infective Agents