Staphylococcus Aureus Bacteremia, Methicillin-resistant Staphylococcus Aureus (MRSA) Bacteremia
Conditions
Keywords
Staphylococcus aureus bacteremia, Methicillin-resistant Staphylococcus aureus bacteremia, MRSA bacteremia, Blood, Adult, Infections, Blood Culture
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.
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.
Interventions
Ceftaroline fosamil 600 mg intravenous (IV) infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) (dosing may be adjusted for renal function)
Sponsors
Forest Laboratories
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Countries
United States
Outcome results
None listed