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

Primary Purpose

Bacterial Pneumonia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ceftaroline fosamil for Injection
IV Ceftriaxone
Placebo
Clarithromycin
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, IV (intravenous), Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydophila spp, Legionella spp, Multi-drug resistant Streptococcus pneumoniae (MDRSP), antimicrobial resistance, pneumococci, Ceftriaxone, bacteria, ß-lactam, beta-lactam, antibiotic

Eligibility Criteria

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

Inclusion Criteria:

Subjects are required to meet the following inclusion criteria:

  • Community-acquired pneumonia
  • initial hospitalization, or treatment in an emergency room or urgent care setting
  • infection would require initial treatment with IV antimicrobials.

Exclusion Criteria:

Subjects must NOT meet any of the following exclusion criteria:

  • CAP suitable for outpatient therapy with an oral antimicrobial agent
  • respiratory tract infections not due to community-acquired bacterial
  • Non-infectious causes of pulmonary infiltrates
  • Pleural empyema
  • Infection with an atypical organism
  • History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial
  • History of any hypersensitivity or allergic reaction to clarithromycin or any macrolide/ ketolide

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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). In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.

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). In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.

Outcomes

Primary Outcome Measures

Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations
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 to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population

Secondary Outcome Measures

Clinical Response at End of Therapy (EOT)
Microbiological Success Rate at Test of Cure (TOC)
Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC)
Clinical and Microbiological Response by Pathogen at TOC
Clinical Relapse at Late Follow Up (LFU)
Microbiological Re-infection/Recurrence at LFU
Evaluate Safety

Full Information

First Posted
February 11, 2008
Last Updated
February 2, 2017
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00621504
Brief Title
Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects 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, With Adjunctive Clarithromycin, 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
January 2008 (undefined)
Primary Completion Date
December 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 this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia
Detailed Description
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia. Clinical trials for this study is held in many countries

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, IV (intravenous), Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydophila spp, Legionella spp, Multi-drug resistant Streptococcus pneumoniae (MDRSP), antimicrobial resistance, pneumococci, Ceftriaxone, bacteria, ß-lactam, beta-lactam, antibiotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
606 (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). In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
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). In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
Intervention Type
Drug
Intervention Name(s)
Ceftaroline fosamil for Injection
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)
IV Ceftriaxone
Other Intervention Name(s)
Ceftriaxone
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
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Intervention Description
In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
Primary Outcome Measure Information:
Title
Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations
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 to 15 days after last dose of study drug
Title
Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (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 Test of Cure (TOC)
Time Frame
8-15 days after last dose of study drug
Title
Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC)
Time Frame
8-15 days after last day 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)
Time Frame
21-35 days after last dose of study drug
Title
Microbiological Re-infection/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 are required to meet the following inclusion criteria: Community-acquired pneumonia initial hospitalization, or treatment in an emergency room or urgent care setting infection would require initial treatment with IV antimicrobials. Exclusion Criteria: Subjects must NOT meet any of the following exclusion criteria: CAP suitable for outpatient therapy with an oral antimicrobial agent respiratory tract infections not due to community-acquired bacterial Non-infectious causes of pulmonary infiltrates Pleural empyema Infection with an atypical organism History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial History of any hypersensitivity or allergic reaction to clarithromycin or any macrolide/ ketolide
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas M File, MD, MS
Organizational Affiliation
Summa Health System
Official's Role
Study Director
Facility Information:
Facility Name
Investigational site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Facility Name
Investigational Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Investigational Site
City
Fort Gordon
State/Province
Georgia
ZIP/Postal Code
30905
Country
United States
Facility Name
Investigational Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
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United States
Facility Name
Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
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United States
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Investigational site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55422
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United States
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Investigational Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Investigational Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44305
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United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
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United States
Facility Name
Investigational Site
City
Buenos Aires
State/Province
C.a.b.a.
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Investigational Site
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000IIH
Country
Argentina
Facility Name
Investigational Site
City
Buenos Aires
ZIP/Postal Code
1650
Country
Argentina
Facility Name
Investigational Site
City
Buenos Aires
ZIP/Postal Code
1748
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Argentina
Facility Name
Investigational Site
City
Buenos Aires
ZIP/Postal Code
B1702FWM
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Argentina
Facility Name
Investigational Site
City
Buenos Aires
ZIP/Postal Code
B6700AQJ
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Argentina
Facility Name
Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1155ADP
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Argentina
Facility Name
Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1430BKC
Country
Argentina
Facility Name
Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1437 BZK
Country
Argentina
Facility Name
Investigational Site
City
Vicente Lopez
ZIP/Postal Code
1602
Country
Argentina
Facility Name
Investigational Site
City
Vienna
ZIP/Postal Code
A-1090
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Austria
Facility Name
Investigational Site
City
Wien
ZIP/Postal Code
A-1030
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Austria
Facility Name
Investigational Site
City
Goiania
State/Province
G.o.
ZIP/Postal Code
74465-539
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Brazil
Facility Name
Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
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Brazil
Facility Name
Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-001
Country
Brazil
Facility Name
Investigational Site
City
Sao Jose do Rio Preto
State/Province
SP
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Investigational Site 1
City
Belo Horizonte MG
ZIP/Postal Code
30150-221
Country
Brazil
Facility Name
Investigational Site 2
City
Belo Horizonte
ZIP/Postal Code
30140-062
Country
Brazil
Facility Name
Investigational Site
City
Campinas
ZIP/Postal Code
SP 13059-900
Country
Brazil
Facility Name
Investigational Site
City
Curitiba-PR
ZIP/Postal Code
80810-040
Country
Brazil
Facility Name
Investigational Site
City
Juiz de Fora
ZIP/Postal Code
36036-110
Country
Brazil
Facility Name
Investigational site
City
Porto Alegre
ZIP/Postal Code
90035-001
Country
Brazil
Facility Name
Investigational Site
City
Sao Paolo
ZIP/Postal Code
04038-905
Country
Brazil
Facility Name
Investigational Site
City
Sao Paolo
ZIP/Postal Code
17201-340
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Brazil
Facility Name
Investigational Site
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
Investigational Site
City
Sofia
ZIP/Postal Code
1431
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Bulgaria
Facility Name
Investigational Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Investigational Site
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Investigational Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Investigational Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Investigational Site
City
Annecy
ZIP/Postal Code
74000
Country
France
Facility Name
Investigational Site
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Facility Name
Investigational Site
City
Paris
ZIP/Postal Code
750120
Country
France
Facility Name
Investigational Site
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Investigational Site
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Investigational Site
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Facility Name
Investigational Site
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Investigational Site
City
Lindenberger
State/Province
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Investigational Site
City
Bochum
ZIP/Postal Code
44793
Country
Germany
Facility Name
Investigational Site
City
Bochum
ZIP/Postal Code
44879
Country
Germany
Facility Name
Investigational Site
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Name
Investigational Site
City
Heppenheim
ZIP/Postal Code
64646
Country
Germany
Facility Name
Investigational Site
City
Lich
ZIP/Postal Code
53545
Country
Germany
Facility Name
Investigational Site
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Investigational Site
City
Luedenscheid
ZIP/Postal Code
58515
Country
Germany
Facility Name
Investigational Site
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Facility Name
Investigational Site
City
Schkeuditz
ZIP/Postal Code
04435
Country
Germany
Facility Name
Investigational Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Investigational Site
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
Facility Name
Investigational Site
City
Tatabanya
State/Province
Szanatorium
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Investigational Site
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Investigational Site
City
Matrahaza
ZIP/Postal Code
3233
Country
Hungary
Facility Name
Investigational Site
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Investigational Site
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Investigational Site
City
Sopron
ZIP/Postal Code
9400
Country
Hungary
Facility Name
Investigational Site
City
Tatabanya
ZIP/Postal Code
2800
Country
Hungary
Facility Name
Investigational Site
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Investigational Site
City
Vellore
State/Province
Tamilnadu
ZIP/Postal Code
632004
Country
India
Facility Name
Investigational Site
City
Kaunas
ZIP/Postal Code
LT-45130
Country
Lithuania
Facility Name
Investigational Site
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Investigational Site
City
Klaipeda
ZIP/Postal Code
LT-92231
Country
Lithuania
Facility Name
Investigational Site
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
Investigational Site
City
Siauliai
ZIP/Postal Code
LT-76231
Country
Lithuania
Facility Name
Investigational Site
City
Vilnius
ZIP/Postal Code
LT-10207
Country
Lithuania
Facility Name
Investigational Site
City
Johor Bahru
State/Province
Johor
ZIP/Postal Code
80100
Country
Malaysia
Facility Name
Inestigational Site
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
05460
Country
Malaysia
Facility Name
Investigational Site
City
Georgetown
State/Province
Penang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Investigational Site
City
Kedah
ZIP/Postal Code
05460
Country
Malaysia
Facility Name
Investigational Site
City
Kuala Lumpur
ZIP/Postal Code
50590
Country
Malaysia
Facility Name
Investigational Site
City
Bedzin
ZIP/Postal Code
42-500
Country
Poland
Facility Name
Investigational Site
City
Brzesku
ZIP/Postal Code
32-800
Country
Poland
Facility Name
Investigational Site
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Investigational Site
City
Chodziez
ZIP/Postal Code
64-800
Country
Poland
Facility Name
Investigational Site
City
Czestochowa
ZIP/Postal Code
42-200
Country
Poland
Facility Name
Investigational Site
City
Katowice-Ochojec
ZIP/Postal Code
40-635
Country
Poland
Facility Name
Investigational Site
City
Krakow
ZIP/Postal Code
30-053
Country
Poland
Facility Name
Investigational Site
City
Lublin
ZIP/Postal Code
20-178
Country
Poland
Facility Name
Investigational Site
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Investigational Site
City
Poznan
ZIP/Postal Code
60-479
Country
Poland
Facility Name
Investigational Site
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Investigational Site
City
Tychy
ZIP/Postal Code
43-100
Country
Poland
Facility Name
Investigational Site
City
Warszawa
ZIP/Postal Code
01-138
Country
Poland
Facility Name
Investigational Site
City
Warszawa
ZIP/Postal Code
03-401
Country
Poland
Facility Name
Investigational Site
City
Warszawa
ZIP/Postal Code
03-737
Country
Poland
Facility Name
Investigational Site
City
Warszawa
ZIP/Postal Code
127 02-507
Country
Poland
Facility Name
Investigational Site
City
Wroclaw
ZIP/Postal Code
53-439
Country
Poland
Facility Name
Inestigational Site
City
Bucharest
ZIP/Postal Code
042122
Country
Romania
Facility Name
Investigational Site
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
Investigational Site
City
Cluj Napoca
ZIP/Postal Code
400238
Country
Romania
Facility Name
Investigational Site
City
Constanta
Country
Romania
Facility Name
Investigational Site
City
Oradea
ZIP/Postal Code
410176
Country
Romania
Facility Name
Investigational Site
City
St. Brasov
ZIP/Postal Code
25-27
Country
Romania
Facility Name
Investigational Site
City
Targu Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Investigational Site
City
Timisoara
Country
Romania
Facility Name
Investigational Site
City
Petrozavodsk
State/Province
Republic of Karelia
ZIP/Postal Code
185014
Country
Russian Federation
Facility Name
Investigational Site
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Investigational Site
City
Moscow
ZIP/Postal Code
119048
Country
Russian Federation
Facility Name
Investigational Site
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Investigational Site
City
Moscow
ZIP/Postal Code
125206
Country
Russian Federation
Facility Name
Investigational Site
City
Rostov-on-Don
ZIP/Postal Code
344010
Country
Russian Federation
Facility Name
Investigational Site
City
Saratov
ZIP/Postal Code
410-002
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
191104
Country
Russian Federation
Facility Name
Investigational Site
City
St. Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
Investigational Site
City
Tatarstan
ZIP/Postal Code
420-101
Country
Russian Federation
Facility Name
Investigational Site
City
Yekaterinburg
ZIP/Postal Code
620109
Country
Russian Federation
Facility Name
Investigational Site
City
Yekaterinburg
ZIP/Postal Code
620137
Country
Russian Federation
Facility Name
Investigational Site
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Investigational Site
City
Knez Selo
ZIP/Postal Code
18204
Country
Serbia
Facility Name
Investigational Site
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Investigational Site
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
Slovakia
City
Nitra-Zobor
ZIP/Postal Code
948 88
Country
Slovakia
Facility Name
Investigational Site
City
Bellville
State/Province
Capetown
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Investigational Site
City
Benomi
ZIP/Postal Code
1500
Country
South Africa
Facility Name
Investigational Site
City
Cape Town
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Investigational Site
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Investigational Site
City
Krugersdorp
ZIP/Postal Code
1752
Country
South Africa
Facility Name
Investigational Site
City
Port Elizabeth
ZIP/Postal Code
6020
Country
South Africa
Facility Name
Investigational Site
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Investigational Site
City
Pretoria
ZIP/Postal Code
0084
Country
South Africa
Facility Name
Investigational Site
City
Pretoria
ZIP/Postal Code
0140
Country
South Africa
Facility Name
Investigational Site
City
Pretoria
ZIP/Postal Code
0188
Country
South Africa
Facility Name
Investigational Site
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Investigational Site
City
Worcester
ZIP/Postal Code
6850
Country
South Africa
Facility Name
Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Investigational Site
City
Elche
ZIP/Postal Code
03203
Country
Spain
Facility Name
Investigational Site
City
Leon
ZIP/Postal Code
24411
Country
Spain
Facility Name
Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Investigational Site
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Investigational Site
City
Vizcaya
ZIP/Postal Code
48960
Country
Spain
Facility Name
Investigational Site
City
Biel
ZIP/Postal Code
2501
Country
Switzerland
Facility Name
Investigational Site
City
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Investigational Site
City
La Chaux-de-Fonds
ZIP/Postal Code
2300
Country
Switzerland
Facility Name
Investigational Site
City
Lugano
ZIP/Postal Code
46,6903
Country
Switzerland
Facility Name
Investigational Site
City
Bangkok
ZIP/Postal Code
10110
Country
Thailand
Facility Name
Investigational Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
InvestigationalSite
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Investigational Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Investigational Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Investigational Site
City
Khonkaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Investigational Site
City
Nonthaburi
ZIP/Postal Code
11000
Country
Thailand
Facility Name
Investigational Site
City
Aviv
ZIP/Postal Code
79013
Country
Ukraine
Facility Name
Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49074
Country
Ukraine
Facility Name
Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Investigational Site
City
Donetsk
ZIP/Postal Code
83099
Country
Ukraine
Facility Name
Investigational Site
City
Ivano-Frankivsk
ZIP/Postal Code
76025
Country
Ukraine
Facility Name
Investigational Site
City
Kharkiv
ZIP/Postal Code
61018
Country
Ukraine
Facility Name
Investigational Site
City
Kharkiv
ZIP/Postal Code
61035
Country
Ukraine
Facility Name
Inestigational Site
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Investigational Site
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Investigational Site
City
Lugansk
ZIP/Postal Code
91045
Country
Ukraine
Facility Name
Investigational Site
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Investigational Site
City
Poltava
ZIP/Postal Code
36038
Country
Ukraine
Facility Name
Investigational Site
City
Uzhorod
ZIP/Postal Code
88015
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
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
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
21482566
Citation
File TM Jr, Low DE, Eckburg PB, Talbot GH, Friedland HD, Lee J, Llorens L, Critchley IA, Thye DA; FOCUS 1 investigators. FOCUS 1: 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:iii19-32. doi: 10.1093/jac/dkr096.
Results Reference
derived
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 Adult Subjects With Community-Acquired Pneumonia

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