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:

Information provided by (Responsible Party):

Forest Laboratories

ClinicalTrials.gov Identifier:

NCT01701219

First received: October 3, 2012

Last updated: July 30, 2014

Last verified: July 2014

History of Changes

Tracking Information
First Received Date ^ICMJE	October 3, 2012
Last Updated Date	July 30, 2014
Start Date ^ICMJE	January 2013
Primary Completion Date	May 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 30, 2014)	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 ] [ Designated as safety issue: No ] Efficacy outcome measures: Time to clearance of bacteremia Time to defervescence Clinical outcome Mortality Readmission
Original Primary Outcome Measures ^ICMJE (submitted: October 3, 2012)	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
Change History	Complete list of historical versions of study NCT01701219 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 30, 2014)	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 ] [ 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
Original Secondary Outcome Measures ^ICMJE (submitted: October 3, 2012)	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
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 Arm (s)	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	56
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.
Gender	Both
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
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	No
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	Forest Laboratories
Study Sponsor ^ICMJE	Forest Laboratories
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	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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