NCT01701219

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

1.3 years

First QC Date

October 3, 2012

Last Update Submit

July 30, 2014

Conditions

Staphylococcus Aureus BacteremiaMethicillin-resistant Staphylococcus Aureus (MRSA) Bacteremia

Keywords

Staphylococcus aureus bacteremiaMethicillin-resistant Staphylococcus aureus bacteremiaMRSA bacteremiaBloodAdultInfectionsBlood Culture

Outcome Measures

Primary Outcomes (1)

  • 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

    60 days following completion of antibacterial therapy and discharge from the hospital, anticipated between 74 to 119 days

Secondary Outcomes (1)

  • 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

    Between 3 and 119 days

Study Arms (2)

Cohort A

OTHER

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

Drug: Ceftaroline fosamil

Cohort B

OTHER

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

Interventions

Ceftaroline fosamilDRUG

Ceftaroline fosamil 600 mg intravenous (IV) infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) (dosing may be adjusted for renal function)

Also known as: Teflaro®, PPI-0903, TAK-599, TAK599, PPI0903, Zinforo
Cohort ACohort B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Investigational Site

Birmingham, Alabama, 35294, United States

Location

Investigational Site

Sacramento, California, 95817, United States

Location

Investigational Site

San Francisco, California, 94110, United States

Location

Investigational Site

Sylmar, California, 91342, United States

Location

Investigational Site

Torrance, California, 90502, United States

Location

Investigational Site

Hartford, Connecticut, 06102, United States

Location

Investigational Site

Pensacola, Florida, 32504, United States

Location

Investigational Site

Stuart, Florida, 34994, United States

Location

Investigational Site

Decatur, Georgia, 30030, United States

Location

Investigational Site

Macon, Georgia, 31201, United States

Location

Investigational Site

Chicago, Illinois, 60612, United States

Location

Investigational Site

Fort Wayne, Indiana, 46845, United States

Location

Investigational Site

Louisville, Kentucky, 40202, United States

Location

Investigational Site

Boston, Massachusetts, 02111, United States

Location

Investigational Site

Detroit, Michigan, 48201, United States

Location

Investigational Site

Detroit, Michigan, 48202, United States

Location

Investigational Site

Grosse Pointe Woods, Michigan, 48236, United States

Location

Investigational Site

Royal Oak, Michigan, 48073, United States

Location

Investigational Site

Laconia, New Hampshire, 03246, United States

Location

Investigational Site

Neptune City, New Jersey, 07753, United States

Location

Investigational Site

Newark, New Jersey, 07102, United States

Location

Investigational Site

Jamaica, New York, 11418, United States

Location

Investigational Site

Toledo, Ohio, 43620, United States

Location

Investigational Site

Greenville, South Carolina, 29605, United States

Location

Investigational Site

Houston, Texas, 77030, United States

Location

Investigational Site

Annandale, Virginia, 22003, United States

Location

Investigational Site

Roanoke, Virginia, 24014, United States

Location

Related Links

MeSH Terms

Conditions

BacteremiaInfections

Interventions

Ceftaroline

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2012

First Posted

October 5, 2012

Study Start

January 1, 2013

Primary Completion

May 1, 2014

Study Completion

July 1, 2014

Last Updated

July 31, 2014

Record last verified: 2014-07

Locations

US(27)