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

July 30, 2014 updated by: Forest Laboratories

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Investigational Site
    • California
      • Sacramento, California, United States, 95817
        • Investigational Site
      • San Francisco, California, United States, 94110
        • Investigational Site
      • Sylmar, California, United States, 91342
        • Investigational Site
      • Torrance, California, United States, 90502
        • Investigational Site
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Investigational Site
    • Florida
      • Pensacola, Florida, United States, 32504
        • Investigational Site
      • Stuart, Florida, United States, 34994
        • Investigational Site
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Investigational Site
      • Macon, Georgia, United States, 31201
        • Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Investigational Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Investigational Site
      • Detroit, Michigan, United States, 48201
        • Investigational Site
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Investigational Site
      • Royal Oak, Michigan, United States, 48073
        • Investigational Site
    • New Hampshire
      • Laconia, New Hampshire, United States, 03246
        • Investigational Site
    • New Jersey
      • Neptune, New Jersey, United States, 07753
        • Investigational Site
      • Newark, New Jersey, United States, 07102
        • Investigational Site
    • New York
      • Jamaica, New York, United States, 11418
        • Investigational Site
    • Ohio
      • Toledo, Ohio, United States, 43620
        • Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Investigational Site
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Investigational Site
      • Roanoke, Virginia, United States, 24014
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cohort A
S. aureus on at least 1 blood culture within 72 hours of beginning study drug
Drug: Ceftaroline fosamil
Ceftaroline fosamil 600 mg intravenous (IV) infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) (dosing may be adjusted for renal function)
Other Names:
  • PPI-0903
  • TAK-599
  • TAK599
  • PPI0903
  • Teflaro®
  • Zinforo
Other: Cohort B
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
Ceftaroline fosamil 600 mg intravenous (IV) infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) (dosing may be adjusted for renal function)
Other Names:
  • PPI-0903
  • TAK-599
  • TAK599
  • PPI0903
  • Teflaro®
  • Zinforo

What is the study measuring?

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
Time Frame: 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
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
Time Frame: 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
Between 3 and 119 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

October 3, 2012

First Posted (Estimate)

October 5, 2012

Study Record Updates

Last Update Posted (Estimate)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 30, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPT-MD-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Staphylococcus Aureus Bacteremia

Clinical Trials on Ceftaroline fosamil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe