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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01701219

First Posted: October 5, 2012

Last Update Posted: July 31, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Forest Laboratories

Tracking Information

First Submitted Date ^ICMJE

October 3, 2012

First Posted Date ^ICMJE

October 5, 2012

Last Update Posted Date

July 31, 2014

Start Date ^ICMJE

January 2013

Primary Completion Date

May 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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 ]

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

Change History

Complete list of historical versions of study NCT01701219 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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 ]

Efficacy outcome measures:

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

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

Intervention ^ICMJE

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

Study Arms

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2014

Primary Completion Date

May 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01701219

Other Study ID Numbers ^ICMJE

CPT-MD-32

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Forest Laboratories

Study Sponsor ^ICMJE

Forest Laboratories

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Forest Laboratories

Verification Date

July 2014

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

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