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Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections

Primary Purpose

Complicated Skin and Soft Tissue Infection

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ceftaroline fosamil
Vancomycin
Aztreonam
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complicated Skin and Soft Tissue Infection focused on measuring complicated skin and soft tissue infections (cSSTI), skin infection, ceftaroline, wound infection, cellulitis, burn infection, bacterial infection, vancomycin

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, aged 18 years or older
  • Complicated skin and skin structure infection (cSSTI)
  • Infection of sufficient severity to warrant hospitalization
  • Infection of sufficient severity such that it is expected to require at least 5 days of intravenous antibiotic therapy

Exclusion Criteria:

  • Received systemic antibacterial drugs for greater than 24 hours within 96 hours prior to first dose of study drug
  • Uncomplicated skin and skin structure infections, skin infections suspected to be caused by viral or fungal pathogens
  • Diabetic foot infections, decubitus ulcers, ulcers due to peripheral vascular disease
  • Infection caused by human or animal bites, sternal wound infections, bone infection or arthritis due to an infection, critical limb ischemia of the affected limb
  • Chronic liver disease or severe impaired renal function, severe low white blood cell count, burns on greater than 15% of total body surface area, necrotizing skin infection, amputation required of primary site of infection, sustained shock

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ceftaroline fosamil

Vancomycin plus aztreonam

Arm Description

Patients will receive 600 mg of ceftaroline fosamil administered as a 120-minute intravenous infusion very 8 hours. Each dose will be infused in a volume of 250 mL over 120-minutes followed by aztreonam placebo in a volume of 100 mL infused over 30 minutes every 8 hours. In addition vancomycin placebo will be given in a volume of 250 mL infused over 120 minutes every 12 hours. Doses will be adjusted according to the patient's renal function.

Patients will receive combination of vancomycin plus aztreonam. Dose of vancomycin will be based on the patient's actual weight and will receive intravenous vancomycin every 12 hours with each dose infused over 120-minutes. Aztreonam dose will be 1 gram intravenously in a volume of 100 mL infused over 30 minutes every 8 hours. In addition, ceftaroline fosamil placebo will be given in a volume of 250 mL infused over 120 minutes every 8 hours. Doses adjusted according to patients renal function

Outcomes

Primary Outcome Measures

Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.

Secondary Outcome Measures

Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set
Difference in microbiological favorable response rate at TOC in mMITT analysis set. Favorable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.
Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set
Difference in microbiological favorable response rate at TOC in ME. Favourable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.
Clinical Response at End of Treatment (EOT) in MITT Analysis Set
The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline.
Clinical Response at EOT in CE Analysis Set
The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline.
Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC
The observed difference in the clinical relapse rates at LFU (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical relapse rate at LFU is measured by comparing a patient's signs and symptoms at late follow-up to those when they were cured at TOC.
Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set
The observed difference in the early success rates at 48 to 72 hours of treatment (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Early response rate as measured by comparing the participant's signs and symptoms at the 48-72 hour visit to those recorded at study baseline.
Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME
Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set

Full Information

First Posted
December 16, 2011
Last Updated
September 1, 2017
Sponsor
Pfizer
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01499277
Brief Title
Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections
Official Title
A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg Every 8 Hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Forest Laboratories

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.
Detailed Description
A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients with Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complicated Skin and Soft Tissue Infection
Keywords
complicated skin and soft tissue infections (cSSTI), skin infection, ceftaroline, wound infection, cellulitis, burn infection, bacterial infection, vancomycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
802 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ceftaroline fosamil
Arm Type
Experimental
Arm Description
Patients will receive 600 mg of ceftaroline fosamil administered as a 120-minute intravenous infusion very 8 hours. Each dose will be infused in a volume of 250 mL over 120-minutes followed by aztreonam placebo in a volume of 100 mL infused over 30 minutes every 8 hours. In addition vancomycin placebo will be given in a volume of 250 mL infused over 120 minutes every 12 hours. Doses will be adjusted according to the patient's renal function.
Arm Title
Vancomycin plus aztreonam
Arm Type
Active Comparator
Arm Description
Patients will receive combination of vancomycin plus aztreonam. Dose of vancomycin will be based on the patient's actual weight and will receive intravenous vancomycin every 12 hours with each dose infused over 120-minutes. Aztreonam dose will be 1 gram intravenously in a volume of 100 mL infused over 30 minutes every 8 hours. In addition, ceftaroline fosamil placebo will be given in a volume of 250 mL infused over 120 minutes every 8 hours. Doses adjusted according to patients renal function
Intervention Type
Drug
Intervention Name(s)
Ceftaroline fosamil
Intervention Description
IV ceftaroline 600mg every 8 hours
Intervention Type
Drug
Intervention Name(s)
Vancomycin
Intervention Description
IV vancomycin 15mg/kg every 12 hours
Intervention Type
Drug
Intervention Name(s)
Aztreonam
Intervention Description
IV aztreonam 1 g every 8 hours
Primary Outcome Measure Information:
Title
Clinical Response at Test of Cure (TOC) in Modified Intent-to-treat (MITT) Analysis Set
Description
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
Time Frame
7 to 20 days after the last dose of study drug
Title
Clinical Response at TOC in Clinically Evaluable (CE) Analysis Set
Description
The observed difference in the clinical cure rates at TOC (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at TOC visit to those recorded at study baseline.
Time Frame
7 to 20 days after the last dose of study drug
Secondary Outcome Measure Information:
Title
Per Patient Microbiological Response at TOC in Microbiologically Modified-intent-to-treat (mMITT) Analysis Set
Description
Difference in microbiological favorable response rate at TOC in mMITT analysis set. Favorable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.
Time Frame
7 to 20 days after the last dose of study drug
Title
Per-patient Micro Response at TOC in Microbiologically Evaluable (ME) Analysis Set
Description
Difference in microbiological favorable response rate at TOC in ME. Favourable microbiological response rate is measured by comparing TOC microbiological data to baseline microbiological data. In the absence of TOC microbiological data it is presumed from the clinical response.
Time Frame
7 to 20 days after the last dose of study drug
Title
Clinical Response at End of Treatment (EOT) in MITT Analysis Set
Description
The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline.
Time Frame
On day of last dose of study drug (or + 1 day)
Title
Clinical Response at EOT in CE Analysis Set
Description
The observed difference in the clinical cure rates at EOT (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical cure rate is measured by comparing the participant's signs and symptoms at EOT visit to those recorded at study baseline.
Time Frame
On day of last dose of study drug (or +1 day)
Title
Clinical Relapse at Late Follow-up (LFU) in CE Patients Who Were Cured at TOC
Description
The observed difference in the clinical relapse rates at LFU (ceftaroline group minus vancomycin plus aztreonam group) in CE. Clinical relapse rate at LFU is measured by comparing a patient's signs and symptoms at late follow-up to those when they were cured at TOC.
Time Frame
21 to 42 days after the last dose of study drug
Title
Early Response at 48 to 72 Hours of Treatment in MITT Analysis Set
Description
The observed difference in the early success rates at 48 to 72 hours of treatment (ceftaroline group minus vancomycin plus aztreonam group) in MITT. Early response rate as measured by comparing the participant's signs and symptoms at the 48-72 hour visit to those recorded at study baseline.
Time Frame
48 to 72 hours after first dose of study drug
Title
Per-pathogen Microbiological Response at TOC by Baseline Pathogen From Site of Skin Infection in ME
Description
Per-pathogen microbiological response at TOC by baseline pathogen from site of skin infection in ME analysis set
Time Frame
7 to 20 days after the last dose of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, aged 18 years or older Complicated skin and skin structure infection (cSSTI) Infection of sufficient severity to warrant hospitalization Infection of sufficient severity such that it is expected to require at least 5 days of intravenous antibiotic therapy Exclusion Criteria: Received systemic antibacterial drugs for greater than 24 hours within 96 hours prior to first dose of study drug Uncomplicated skin and skin structure infections, skin infections suspected to be caused by viral or fungal pathogens Diabetic foot infections, decubitus ulcers, ulcers due to peripheral vascular disease Infection caused by human or animal bites, sternal wound infections, bone infection or arthritis due to an infection, critical limb ischemia of the affected limb Chronic liver disease or severe impaired renal function, severe low white blood cell count, burns on greater than 15% of total body surface area, necrotizing skin infection, amputation required of primary site of infection, sustained shock
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Melnick, MSD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Chula Vista
State/Province
California
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
Country
United States
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Research Site
City
West Palm Beach
State/Province
Florida
Country
United States
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City
Carmel
State/Province
Indiana
Country
United States
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City
Hazard
State/Province
Kentucky
Country
United States
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Springfield
State/Province
Massachusetts
Country
United States
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Detroit
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Michigan
Country
United States
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Las Vegas
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Nevada
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United States
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Garden City
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New York
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United States
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Bellaire
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Texas
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United States
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Córdoba
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Argentina
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Santa Fe
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Argentina
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Parkville
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Australia
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Bruxelles
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Belgium
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Belo Horizonte
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Brazil
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Passo Fundo
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Brazil
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Salvador
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Brazil
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São José do Rio Preto
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Brazil
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Pleven
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Bulgaria
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City
Ruse
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Bulgaria
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Sofia
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Bulgaria
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Temuco
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Chile
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Viña del Mar
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Chile
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Beijing
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China
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Changchun
Country
China
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Changsha
Country
China
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Chengdu
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China
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Chongqing
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China
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Fuzhou
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China
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Guangzhou
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China
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Haikou
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China
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Nanning
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China
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Qingdao
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China
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Shanghai
Country
China
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Shenyang
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China
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Shijiazhuang
Country
China
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Wuhan
Country
China
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Xi'an
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China
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Slavonski Brod
Country
Croatia
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Zagreb
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Croatia
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Jihlava
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Czechia
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Pardubice
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Czechia
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Orleans
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France
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Dessau
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Germany
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Hanau
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Germany
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Heilbronn
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Germany
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Athens
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Greece
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Kowloon
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Hong Kong
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Pokfulam
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Hong Kong
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Haifa
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Israel
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Ramat-Gan
Country
Israel
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Safed
Country
Israel
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Tel Aviv
Country
Israel
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Milano
Country
Italy
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City
Ansan
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Korea, Republic of
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City
Deagu
Country
Korea, Republic of
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City
Incheon
Country
Korea, Republic of
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City
Seoul
Country
Korea, Republic of
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City
Won-ju
Country
Korea, Republic of
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Guadalajara
Country
Mexico
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Cusco
Country
Peru
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Lima
Country
Peru
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Manila
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Philippines
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Quezon City
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Philippines
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Lublin
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Poland
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Łódź
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Poland
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Bucharest
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Romania
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Moscow
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Russian Federation
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Perm
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Russian Federation
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Saint Petersburg
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Russian Federation
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Smolensk
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Russian Federation
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Vsevolozhsk
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Russian Federation
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Yaroslavl
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Russian Federation
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Benoni
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South Africa
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Cape Town
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South Africa
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Johannesburg
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South Africa
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Worcester
Country
South Africa
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Barcelona
Country
Spain
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Granada
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Spain
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Madrid
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Spain
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Terrassa
Country
Spain
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Kaohsiung
Country
Taiwan
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City
Taipei
Country
Taiwan
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City
Yung Kang City
Country
Taiwan
Facility Name
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City
Ankara
Country
Turkey
Facility Name
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City
Diyarbakir
Country
Turkey
Facility Name
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City
Izmir
Country
Turkey
Facility Name
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City
Cherkasy
Country
Ukraine
Facility Name
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Ivano-Frankivsk
Country
Ukraine
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Kharkov
Country
Ukraine
Facility Name
Research Site
City
Odesa
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
34922058
Citation
Dryden M, Kantecki M, Yan JL, Stone GG, Leister-Tebbe H, Wilcox M. Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials. J Glob Antimicrob Resist. 2022 Mar;28:108-114. doi: 10.1016/j.jgar.2021.10.027. Epub 2021 Dec 16.
Results Reference
derived
PubMed Identifier
34741280
Citation
Wilcox M, Yan JL, Gonzalez PL, Dryden M, Stone GG, Kantecki M. Impact of Underlying Comorbidities on Outcomes of Patients Treated with Ceftaroline Fosamil for Complicated Skin and Soft Tissue Infections: Pooled Results from Three Phase III Randomized Clinical Trials. Infect Dis Ther. 2022 Feb;11(1):217-230. doi: 10.1007/s40121-021-00557-w. Epub 2021 Nov 6.
Results Reference
derived
PubMed Identifier
32607967
Citation
Sanchez-Garcia M, Hammond J, Yan JL, Kantecki M, Ansari W, Dryden M. Baseline Characteristics and Outcomes Among Patients with Complicated Skin and Soft Tissue Infections Admitted to the Intensive Care Unit: Analysis of the Phase 3 COVERS Randomized Trial of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam. Infect Dis Ther. 2020 Sep;9(3):609-623. doi: 10.1007/s40121-020-00297-3. Epub 2020 Jun 30.
Results Reference
derived
PubMed Identifier
30716446
Citation
Corey GR, Wilcox MH, Gonzalez J, Jandourek A, Wilson DJ, Friedland HD, Das S, Iaconis J, Dryden M. Ceftaroline fosamil therapy in patients with acute bacterial skin and skin-structure infections with systemic inflammatory signs: A retrospective dose comparison across three pivotal trials. Int J Antimicrob Agents. 2019 Jun;53(6):830-837. doi: 10.1016/j.ijantimicag.2019.01.016. Epub 2019 Feb 1.
Results Reference
derived
PubMed Identifier
30597021
Citation
Cheng K, Pypstra R, Yan JL, Hammond J. Summary of the safety and tolerability of two treatment regimens of ceftaroline fosamil: 600 mg every 8 h versus 600 mg every 12 h. J Antimicrob Chemother. 2019 Apr 1;74(4):1086-1091. doi: 10.1093/jac/dky519.
Results Reference
derived
PubMed Identifier
30380060
Citation
Das S, Li J, Iaconis J, Zhou D, Stone GG, Yan JL, Melnick D. Ceftaroline fosamil doses and breakpoints for Staphylococcus aureus in complicated skin and soft tissue infections. J Antimicrob Chemother. 2019 Feb 1;74(2):425-431. doi: 10.1093/jac/dky439.
Results Reference
derived
PubMed Identifier
27585969
Citation
Dryden M, Zhang Y, Wilson D, Iaconis JP, Gonzalez J. A Phase III, randomized, controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in patients with complicated skin and soft tissue infection with systemic inflammatory response or underlying comorbidities. J Antimicrob Chemother. 2016 Dec;71(12):3575-3584. doi: 10.1093/jac/dkw333. Epub 2016 Sep 1.
Results Reference
derived

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Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections

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