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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: Ceftaroline fosamil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort A<br>S. aureus on at least 1 blood culture within 72 hours of beginning study drug | Drug: Ceftaroline fosamil<br>* Ceftaroline fosamil 600 mg intravenous (IV) infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) (dosing may be adjusted for renal function)<br>* Other names: Zinforo;|
| Other: Cohort B<br>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<br>* Ceftaroline fosamil 600 mg intravenous (IV) infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) (dosing may be adjusted for renal function)<br>* Other names: Zinforo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Efficacy outcome measures: Time to clearance of bacteremia Time to defervescence Clinical outcome Mortality Readmission | 60 days following completion of antibacterial therapy and discharge from the hospital, anticipated between 74 to 119 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Between 3 and 119 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Staphylococcus aureus bacteremia, Methicillin-resistant Staphylococcus aureus bacteremia, MRSA bacteremia, Blood, Adult, Infections, Blood Culture