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

October 3, 2012
February 10, 2014
January 2013
March 2014   (final data collection date for primary outcome 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 [ 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
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 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
Complete list of historical versions of study NCT01701219 on ClinicalTrials.gov Archive Site
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
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 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
Not Provided
Not Provided
 
Safety and Efficacy Study of Ceftaroline in Subjects With Staphylococcus Aureus Bacteremia or With Persistent Methicillin-Resistant Staphylococcus Aureus Bacteremia
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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Staphylococcus Aureus Bacteremia
  • Methicillin-resistant Staphylococcus Aureus (MRSA) Bacteremia
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 A
    S. aureus on at least 1 blood culture within 72 hours of beginning study drug
    Intervention: Drug: Ceftaroline fosamil
  • 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
    Intervention: Drug: Ceftaroline fosamil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
September 2014
March 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01701219
CPT-MD-32
No
Cerexa, Inc.
Cerexa, Inc.
Not Provided
Not Provided
Cerexa, Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP