Clinical trial NCT01701219: Safety and Efficacy Study of Ceftaroline in Subjects With Staphylococcus Aureus Bacteremia or With Persistent Methicillin-Resistant Staphylococcus Aureus Bacteremia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Staphylococcus Aureus Bacteremia
Methicillin-resistant Staphylococcus Aureus (MRSA) Bacteremia
Keywords: Staphylococcus aureus bacteremia
Methicillin-resistant Staphylococcus aureus bacteremia
MRSA bacteremia
Blood
Adult
Infections
Blood Culture
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2012-10-05
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 60 days following completion of antibacterial therapy and discharge from the hospital, anticipated between 74 to 119 days
Secondary outcomes:
measure: 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
timeFrame: Between 3 and 119 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site
state: Alabama
city: Sacramento
country: United States
facility: Investigational Site
state: California
city: San Francisco
country: United States
facility: Investigational Site
state: California
city: Sylmar
country: United States
facility: Investigational Site
state: California
city: Torrance
country: United States
facility: Investigational Site
state: California
city: Hartford
country: United States
facility: Investigational Site
state: Connecticut
city: Pensacola
country: United States
facility: Investigational Site
state: Florida
city: Stuart
country: United States
facility: Investigational Site
state: Florida
city: Decatur
country: United States
facility: Investigational Site
state: Georgia
city: Macon
country: United States
facility: Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Investigational Site
state: Illinois
city: Fort Wayne
country: United States
facility: Investigational Site
state: Indiana
city: Louisville
country: United States
facility: Investigational Site
state: Kentucky
city: Boston
country: United States
facility: Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: Investigational Site
state: Michigan
city: Detroit
country: United States
facility: Investigational Site
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Investigational Site
state: Michigan
city: Royal Oak
country: United States
facility: Investigational Site
state: Michigan
city: Laconia
country: United States
facility: Investigational Site
state: New Hampshire
city: Neptune
country: United States
facility: Investigational Site
state: New Jersey
city: Newark
country: United States
facility: Investigational Site
state: New Jersey
city: Jamaica
country: United States
facility: Investigational Site
state: New York
city: Toledo
country: United States
facility: Investigational Site
state: Ohio
city: Greenville
country: United States
facility: Investigational Site
state: South Carolina
city: Houston
country: United States
facility: Investigational Site
state: Texas
city: Annandale
country: United States
facility: Investigational Site
state: Virginia
city: Roanoke
country: United States
facility: Investigational Site
state: Virginia
Study officials:
References: