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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cerexa, Inc.
ClinicalTrials.gov Identifier:
NCT01701219
First received: October 3, 2012
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Staphylococcus Aureus Bacteremia
Methicillin-resistant Staphylococcus Aureus (MRSA) Bacteremia
Drug: Ceftaroline fosamil
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cerexa, Inc.:

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 [ Time Frame: Between 3 and 119 days ] [ Designated as safety issue: Yes ]

    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


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 [ Time Frame: 60 days following completion of antibacterial therapy and discharge from the hospital, anticipated between 74 to 119 days ] [ Designated as safety issue: No ]

    Efficacy outcome measures:

    • Time to clearance of bacteremia
    • Time to defervescence
    • Clinical outcome
    • Mortality
    • Readmission


Estimated Enrollment: 60
Study Start Date: January 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Teflaro®
  • PPI-0903
  • TAK-599
  • TAK599
  • PPI0903
  • Zinforo
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:
  • Teflaro®
  • PPI-0903
  • TAK-599
  • TAK599
  • PPI0903
  • Zinforo

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01701219

  Show 27 Study Locations
Sponsors and Collaborators
Cerexa, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Cerexa, Inc.
ClinicalTrials.gov Identifier: NCT01701219     History of Changes
Other Study ID Numbers: CPT-MD-32
Study First Received: October 3, 2012
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Cerexa, Inc.:
Staphylococcus aureus bacteremia
Methicillin-resistant Staphylococcus aureus bacteremia
MRSA bacteremia
Blood
Adult
Infections
Blood Culture

Additional relevant MeSH terms:
Bacteremia
Staphylococcal Infections
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Gram-Positive Bacterial Infections
Methicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014