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Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia (CAP)

Primary Purpose

Bacterial Pneumonia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ceftaroline fosamil for Injection
Ceftriaxone
Placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Pneumonia focused on measuring ceftaroline, Community-acquired pneumonia, CAP, Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydophila spp, Legionella ssp, multi-drug resistant Streptococcus pneumoniae (MDRSP), antimicrobial resistance, pneumococci, beta-lactam, ceftaroline fosamil, ceftriaxone, antibiotic

Eligibility Criteria

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

Inclusion Criteria:

Subjects with community-acquired pneumonia requiring:

  • initial hospitalization or treatment in an emergency room or urgent care setting
  • infection requiring initial treatment with IV antimicrobial

Exclusion Criteria:

  • Community-acquired pneumonia suitable for outpatient therapy with an oral antimicrobial agent
  • Respiratory tract infections not due to community-acquired bacterial pathogens
  • Infections resistant to ceftriaxone
  • Any condition requiring concomitant systemic corticosteroids
  • History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ceftaroline fosamil for injection

IV Ceftriaxone

Arm Description

Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).

Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).

Outcomes

Primary Outcome Measures

Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population
Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome
Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population

Secondary Outcome Measures

Clinical Response at End of Therapy (EOT)
Microbiological Success Rate at TOC
Overall Clinical and Radiographic Success Rate at TOC
Clinical and Microbiological Response by Pathogen at TOC
Clinical Relapse at Late Follow Up (LFU) Visit
Microbiological Reinfection/Recurrence at LFU
Evaluate Safety

Full Information

First Posted
July 27, 2007
Last Updated
February 2, 2017
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00509106
Brief Title
Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia
Acronym
CAP
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone in the Treatment of Adult Subjects With Community-Acquired Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.
Detailed Description
Clinical trials is being held in different countries. The purpose of the study is to determine if the antibiotic ceftaroline is safe and effective in the treatment of community-acquired pneumonia in adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Pneumonia
Keywords
ceftaroline, Community-acquired pneumonia, CAP, Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydophila spp, Legionella ssp, multi-drug resistant Streptococcus pneumoniae (MDRSP), antimicrobial resistance, pneumococci, beta-lactam, ceftaroline fosamil, ceftriaxone, antibiotic

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Ceftaroline fosamil for injection
Arm Type
Experimental
Arm Description
Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
Arm Title
IV Ceftriaxone
Arm Type
Active Comparator
Arm Description
Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
Intervention Type
Drug
Intervention Name(s)
Ceftaroline fosamil for Injection
Other Intervention Name(s)
Experimental
Intervention Description
2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days
Intervention Type
Drug
Intervention Name(s)
Ceftriaxone
Other Intervention Name(s)
Active comparator
Intervention Description
1 g dose parenteral infused over 30 minutes, every 24 hours for 5 to 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind
Primary Outcome Measure Information:
Title
Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population
Description
Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome
Time Frame
8-15 days after last dose of study drug
Title
Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population
Time Frame
8-15 days after last dose of study drug
Secondary Outcome Measure Information:
Title
Clinical Response at End of Therapy (EOT)
Time Frame
Last day of study drug administration
Title
Microbiological Success Rate at TOC
Time Frame
8-15 days after last dose of study drug
Title
Overall Clinical and Radiographic Success Rate at TOC
Time Frame
8-15 days after last dose of study drug
Title
Clinical and Microbiological Response by Pathogen at TOC
Time Frame
8-15 days after last dose of study drug
Title
Clinical Relapse at Late Follow Up (LFU) Visit
Time Frame
21-35 days after last dose of study drug
Title
Microbiological Reinfection/Recurrence at LFU
Time Frame
21 to 35 days after last dose of study drug
Title
Evaluate Safety
Time Frame
first dose, throughout the treatment period, and up to the TOC visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with community-acquired pneumonia requiring: initial hospitalization or treatment in an emergency room or urgent care setting infection requiring initial treatment with IV antimicrobial Exclusion Criteria: Community-acquired pneumonia suitable for outpatient therapy with an oral antimicrobial agent Respiratory tract infections not due to community-acquired bacterial pathogens Infections resistant to ceftriaxone Any condition requiring concomitant systemic corticosteroids History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
IM Hoepelman, MD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
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United States
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Investigational Site
City
Autonoma
State/Province
Buenos Aires
ZIP/Postal Code
B1722FJN
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Argentina
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Investigational Site
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Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
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Argentina
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Investigational Site
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Merlo
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Buenos Aires
ZIP/Postal Code
B1722FJN
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Argentina
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Investigational Site
City
Buenos Aires
ZIP/Postal Code
174
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Argentina
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Investigational Site
City
Buenos Aires
ZIP/Postal Code
B1602DOH
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Argentina
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Investigational Site
City
Buenos Aires
ZIP/Postal Code
B1657BHD
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Argentina
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Investigational Site
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Buenos Aires
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B1870CID
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Argentina
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Investigational Site
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Buenos Aires
ZIP/Postal Code
B1902AVG
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Argentina
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Buenos Aires
ZIP/Postal Code
B8000AAT
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Argentina
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Investigational Site
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Buenos Aires
ZIP/Postal Code
C1039AAO
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Argentina
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Buenos Aires
ZIP/Postal Code
C1180AAX
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Argentina
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Buenos Aires
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Argentina
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Cordoba
ZIP/Postal Code
520
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Argentina
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Cordoba
ZIP/Postal Code
X5000HGX
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Argentina
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Cordoba
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X5000JQB
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Argentina
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Cordoba
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X5000JRD
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Argentina
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Cordoba
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X5004CDT
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Argentina
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Entre Rios
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E3100BBJ
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Argentina
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Granadero Baiggoria
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S152EDD
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Argentina
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Parana
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E3100BBJ
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Argentina
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Santa Fe
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S2152EDD
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Argentina
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Santa Fe
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S3000EOY
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Argentina
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Grieskirchner
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Wels
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4600
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Austria
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Steyr
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4400
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Austria
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Wels
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42
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Austria
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Wien
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1141
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Austria
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Plovdiv
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4002
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Bulgaria
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Rousse
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7000
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Bulgaria
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Sofia
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1233
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Bulgaria
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Sofia
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1431
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Bulgaria
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Sofia
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1606
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Bulgaria
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Sofia
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1784
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Bulgaria
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Varna
ZIP/Postal Code
9010
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Bulgaria
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San Ignacio
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Valparaiso
ZIP/Postal Code
725
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Chile
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Santiago
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3 Piso
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Chile
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Santiago
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4 Piso
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Chile
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Santiago
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Chile
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Talcahuano
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Chile
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Temuco
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Chile
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Valdivia
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Of.5
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Chile
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Valdivia
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Chile
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Valparaiso
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Chile
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Aachen
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52057
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Germany
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Aachen
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D-52057
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Germany
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Berlin
ZIP/Postal Code
12559
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Germany
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Berlin
ZIP/Postal Code
14165
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Germany
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Berlin
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14165
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Germany
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Berlin
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D-12351
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Germany
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Dachau
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85221
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Germany
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Frankfurt am Main
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60487
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Germany
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Frankfurt
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60487
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Germany
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Greifswald
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17475
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Germany
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Halle/Saale
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06120
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Germany
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Hannover
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30625
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Germany
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Heidelberg
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69120
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Germany
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Hofheim
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65719
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Germany
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Immenhausen
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34376
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Germany
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Lubeck
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23538
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Germany
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Rotenburg (Wuemme)
ZIP/Postal Code
27356
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Germany
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Rotenburg
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27356
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Germany
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Wuppertal
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42283
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Germany
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Gyor
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9023
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Hungary
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Nyiregyhaza
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4400
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Hungary
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Nyiregyhaza
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4412
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Hungary
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Seregelyesi
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ut3
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Hungary
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Sostoi
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ut.62
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Hungary
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Szekesfehervar
ZIP/Postal Code
8000
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Hungary
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Szent Instvan
ZIP/Postal Code
u.68
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Hungary
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Vasvari Pal
ZIP/Postal Code
u.2
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Hungary
Facility Name
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Bangalore
ZIP/Postal Code
560034
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India
Facility Name
Investigational Site
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Gujarat
ZIP/Postal Code
380054
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India
Facility Name
Investigational Site
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Karnataka
ZIP/Postal Code
560054
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India
Facility Name
Investigational Site
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Karnataka
ZIP/Postal Code
575001
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India
Facility Name
Investigational Site
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Noida
ZIP/Postal Code
201301
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India
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Investigational Site
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Pradesh
Country
India
Facility Name
Investigational Site
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Daugavpils
ZIP/Postal Code
LV-5417
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Latvia
Facility Name
Investigational Site
City
Latvia
ZIP/Postal Code
LV-1002
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Latvia
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Investigational Site
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Liepaja
ZIP/Postal Code
LV-5417
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Latvia
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Riga
ZIP/Postal Code
LV-1001
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Latvia
Facility Name
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Chihuahua
ZIP/Postal Code
31238
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Mexico
Facility Name
Investigational Site
City
Chihuahua
ZIP/Postal Code
CP44280
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Mexico
Facility Name
Investigational Site
City
Jalisco
ZIP/Postal Code
44280
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Mexico
Facility Name
Investigational Site
City
Jalisco
ZIP/Postal Code
45170
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Mexico
Facility Name
Investigational Site
City
Jalisco
ZIP/Postal Code
CP44280
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Mexico
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Investigational Site
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Lima
Country
Mexico
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Investigational Site
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Sonora
ZIP/Postal Code
83000
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Mexico
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Investigational Site
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Lima
ZIP/Postal Code
1
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Peru
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Investigational Site
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Lima
ZIP/Postal Code
31
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Peru
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Investigator Site
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Bialystok
ZIP/Postal Code
15-540
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Poland
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Investigational Site
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Bystra
ZIP/Postal Code
43-360
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Poland
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Chrzanow
ZIP/Postal Code
32-500
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Poland
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Krakow
ZIP/Postal Code
31-066
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Poland
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Krakow
ZIP/Postal Code
31-202
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Poland
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Krakow
ZIP/Postal Code
31-202
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Poland
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Krakow
ZIP/Postal Code
31-531
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Poland
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Lodz
ZIP/Postal Code
90-153
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Poland
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Lodz
ZIP/Postal Code
91-520
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Poland
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Lublin
ZIP/Postal Code
20-954
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Poland
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Poznan
ZIP/Postal Code
60-531
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Poland
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Investigational Site
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Poznan
ZIP/Postal Code
60-569
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Poland
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Skierniewice
ZIP/Postal Code
96-100
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Poland
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Inestigational Site
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Warszawa
ZIP/Postal Code
00-909
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Poland
Facility Name
Investigational Site
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Warszawa
ZIP/Postal Code
00-909
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Poland
Facility Name
Investigational Site
City
Warszawa
ZIP/Postal Code
01-138
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Poland
Facility Name
Investigational Site
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Investigational Site
City
Warszawa
ZIP/Postal Code
04-073
Country
Poland
Facility Name
Investigational Site
City
Wilkowice-Bystra
ZIP/Postal Code
43-365
Country
Poland
Facility Name
Investigational Site
City
Wroclaw
ZIP/Postal Code
50-417
Country
Poland
Facility Name
Investigational Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Investigational Site
City
Zabrze
ZIP/Postal Code
41-803
Country
Poland
Facility Name
Investigational Site
City
Bucharest
ZIP/Postal Code
010825
Country
Romania
Facility Name
Investigational Site
City
Bucharest
ZIP/Postal Code
030303
Country
Romania
Facility Name
Investigational Site
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
Investigational Site
City
Bucharest
ZIP/Postal Code
21659
Country
Romania
Facility Name
Investigational Site
City
Craiova
ZIP/Postal Code
200515
Country
Romania
Facility Name
Investigational Site
City
Moscow
ZIP/Postal Code
109240
Country
Russian Federation
Facility Name
Investigational Site
City
Moscow
ZIP/Postal Code
111020
Country
Russian Federation
Facility Name
Investigational Site
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation
Facility Name
Investigational Site
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Investigational Site
City
St. Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Investigational Site
City
St. Petersburg
ZIP/Postal Code
191180
Country
Russian Federation
Facility Name
Investigational Site
City
St. Petersburg
ZIP/Postal Code
194017
Country
Russian Federation
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Investigational Site
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Investigational Site
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Investigational Site
City
ST. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Investigational Site
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49044
Country
Ukraine
Facility Name
Investigational Site
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Investigational site
City
Kyiv
ZIP/Postal Code
01133
Country
Ukraine
Facility Name
Investigational Site
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Investigational site
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Investigational Site
City
Vinnytsya
ZIP/Postal Code
21000
Country
Ukraine
Facility Name
Investigational Site
City
Zaporizhya
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
Investigational Site
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
34922058
Citation
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Results Reference
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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
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PubMed Identifier
26702925
Citation
Taboada M, Melnick D, Iaconis JP, Sun F, Zhong NS, File TM, Llorens L, Friedland HD, Wilson D. Ceftaroline fosamil versus ceftriaxone for the treatment of community-acquired pneumonia: individual patient data meta-analysis of randomized controlled trials. J Antimicrob Chemother. 2016 Apr;71(4):862-70. doi: 10.1093/jac/dkv415. Epub 2015 Dec 24. Erratum In: J Antimicrob Chemother. 2016 Jun;71(6):1748-9.
Results Reference
derived
PubMed Identifier
25487791
Citation
Lodise TP, Anzueto AR, Weber DJ, Shorr AF, Yang M, Smith A, Zhao Q, Huang X, File TM. Assessment of time to clinical response, a proxy for discharge readiness, among hospitalized patients with community-acquired pneumonia who received either ceftaroline fosamil or ceftriaxone in two phase III FOCUS trials. Antimicrob Agents Chemother. 2015 Feb;59(2):1119-26. doi: 10.1128/AAC.03643-14. Epub 2014 Dec 8.
Results Reference
derived
PubMed Identifier
23357290
Citation
Shorr AF, Kollef M, Eckburg PB, Llorens L, Friedland HD. Assessment of ceftaroline fosamil in the treatment of community-acquired bacterial pneumonia due to Streptococcus pneumoniae: insights from two randomized trials. Diagn Microbiol Infect Dis. 2013 Mar;75(3):298-303. doi: 10.1016/j.diagmicrobio.2012.12.002. Epub 2013 Jan 26.
Results Reference
derived
PubMed Identifier
21482568
Citation
Low DE, File TM Jr, Eckburg PB, Talbot GH, David Friedland H, Lee J, Llorens L, Critchley IA, Thye DA; FOCUS 2 investigators. FOCUS 2: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia. J Antimicrob Chemother. 2011 Apr;66 Suppl 3:iii33-44. doi: 10.1093/jac/dkr097.
Results Reference
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PubMed Identifier
21482570
Citation
Rank DR, Friedland HD, Laudano JB. Integrated safety summary of FOCUS 1 and FOCUS 2 trials: Phase III randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with community-acquired pneumonia. J Antimicrob Chemother. 2011 Apr;66 Suppl 3:iii53-9. doi: 10.1093/jac/dkr099.
Results Reference
derived

Learn more about this trial

Comparative Study of Ceftaroline vs. Ceftriaxone in Adults With Community-Acquired Pneumonia

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