Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Other | S. aureus on at least 1 blood culture within 72 hours of beginning study drug |
|
| Cohort B | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftaroline fosamil | Drug | Ceftaroline fosamil 600 mg intravenous (IV) infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) (dosing may be adjusted for renal function) |
|
| 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:
| 60 days following completion of antibacterial therapy and discharge from the hospital, anticipated between 74 to 119 days |
| 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:
|
Not provided
Inclusion Criteria:
Presence of bacteremia due solely to:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Birmingham | Alabama | 35294 | United States | ||
| Investigational Site |
Not provided
| Label | URL |
|---|---|
| Sponsor Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Between 3 and 119 days |
| Sacramento |
| California |
| 95817 |
| United States |
| Investigational Site | San Francisco | California | 94110 | United States |
| Investigational Site | Sylmar | California | 91342 | United States |
| Investigational Site | Torrance | California | 90502 | United States |
| Investigational Site | Hartford | Connecticut | 06102 | United States |
| Investigational Site | Pensacola | Florida | 32504 | United States |
| Investigational Site | Stuart | Florida | 34994 | United States |
| Investigational Site | Decatur | Georgia | 30030 | United States |
| Investigational Site | Macon | Georgia | 31201 | United States |
| Investigational Site | Chicago | Illinois | 60612 | United States |
| Investigational Site | Fort Wayne | Indiana | 46845 | United States |
| Investigational Site | Louisville | Kentucky | 40202 | United States |
| Investigational Site | Boston | Massachusetts | 02111 | United States |
| Investigational Site | Detroit | Michigan | 48201 | United States |
| Investigational Site | Detroit | Michigan | 48202 | United States |
| Investigational Site | Grosse Pointe Woods | Michigan | 48236 | United States |
| Investigational Site | Royal Oak | Michigan | 48073 | United States |
| Investigational Site | Laconia | New Hampshire | 03246 | United States |
| Investigational Site | Neptune City | New Jersey | 07753 | United States |
| Investigational Site | Newark | New Jersey | 07102 | United States |
| Investigational Site | Jamaica | New York | 11418 | United States |
| Investigational Site | Toledo | Ohio | 43620 | United States |
| Investigational Site | Greenville | South Carolina | 29605 | United States |
| Investigational Site | Houston | Texas | 77030 | United States |
| Investigational Site | Annandale | Virginia | 22003 | United States |
| Investigational Site | Roanoke | Virginia | 24014 | United States |
| ID | Term |
|---|---|
| D016470 | Bacteremia |
| D007239 | Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000097583 | Ceftaroline |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided