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

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ceftaroline fosamil
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Staphylococcus Aureus Bacteremia focused on measuring Staphylococcus aureus bacteremia, Methicillin-resistant Staphylococcus aureus bacteremia, MRSA bacteremia, Blood, Adult, Infections, Blood Culture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site
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  • Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Cohort A

Cohort B

Arm Description

S. aureus on at least 1 blood culture within 72 hours of beginning study drug

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 3, 2012
Last Updated
July 30, 2014
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01701219
Brief Title
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A
Arm Type
Other
Arm Description
S. aureus on at least 1 blood culture within 72 hours of beginning study drug
Arm Title
Cohort B
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ceftaroline fosamil
Other Intervention Name(s)
Teflaro®, PPI-0903, TAK-599, TAK599, PPI0903, Zinforo
Intervention Description
Ceftaroline fosamil 600 mg intravenous (IV) infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) (dosing may be adjusted for renal function)
Primary Outcome Measure Information:
Title
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
Description
Efficacy outcome measures: Time to clearance of bacteremia Time to defervescence Clinical outcome Mortality Readmission
Time Frame
60 days following completion of antibacterial therapy and discharge from the hospital, anticipated between 74 to 119 days
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
Between 3 and 119 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Investigational Site
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Investigational Site
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Investigational Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Investigational Site
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Facility Name
Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Investigational Site
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Investigational Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Investigational Site
City
Grosse Pointe Woods
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Investigational Site
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Investigational Site
City
Laconia
State/Province
New Hampshire
ZIP/Postal Code
03246
Country
United States
Facility Name
Investigational Site
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Investigational Site
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Investigational Site
City
Jamaica
State/Province
New York
ZIP/Postal Code
11418
Country
United States
Facility Name
Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43620
Country
United States
Facility Name
Investigational Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Investigational Site
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Investigational Site
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.cerexa.com
Description
Sponsor Website

Learn more about this trial

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

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