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Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections

Primary Purpose

Bacterial Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ceftaroline
vancomycin plus aztreonam
Placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Infections focused on measuring Abscess, Antibacterial, Antibiotic, Antimicrobial, Bacterial infection, skin, Ceftaroline, Ceftaroline acetate, Cellulitis, Cephalosporin, Complicated skin and skin structure infection (cSSSI), cSSSI, Intravenous, Methicillin-resistant Staphylococcus Aureus (MRSA), PPI-0903, Prodrug, Skin disease, bacterial, Skin infection, Staphylococcal skin infection, Staphylococcus aureus, Streptococcal skin infection, Surgical site infection, TAK-599

Eligibility Criteria

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

Inclusion Criteria:

  • Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease.

Exclusion Criteria:

  • Prior treatment of current complicated skin and skin structure infection (cSSSI) with an antimicrobial.
  • Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ceftaroline fosamil for Injection

IV Vancomycin plus IV Aztreonam

Arm Description

Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.

Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.

Outcomes

Primary Outcome Measures

Clinical Cure Rate at Test of Cure (TOC) (MITT Population)
Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary. Failure: Requirement of alternative antimicrobial therapy for primary infection of complicated skin and skin structure infection (cSSSI) due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI. Indeterminate: Inability to determine an outcome
The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations.

Secondary Outcome Measures

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

Full Information

First Posted
January 16, 2007
Last Updated
February 2, 2017
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00423657
Brief Title
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
Official Title
A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection (cSSSI)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

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 complicated skin infections in adults.
Detailed Description
Additional purpose of this study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections
Keywords
Abscess, Antibacterial, Antibiotic, Antimicrobial, Bacterial infection, skin, Ceftaroline, Ceftaroline acetate, Cellulitis, Cephalosporin, Complicated skin and skin structure infection (cSSSI), cSSSI, Intravenous, Methicillin-resistant Staphylococcus Aureus (MRSA), PPI-0903, Prodrug, Skin disease, bacterial, Skin infection, Staphylococcal skin infection, Staphylococcus aureus, Streptococcal skin infection, Surgical site infection, TAK-599

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Ceftaroline fosamil for Injection
Arm Type
Experimental
Arm Description
Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
Arm Title
IV Vancomycin plus IV Aztreonam
Arm Type
Active Comparator
Arm Description
Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
Intervention Type
Drug
Intervention Name(s)
ceftaroline
Other Intervention Name(s)
Experimental
Intervention Description
600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
Intervention Type
Drug
Intervention Name(s)
vancomycin plus aztreonam
Other Intervention Name(s)
Active Comparator
Intervention Description
vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
Primary Outcome Measure Information:
Title
Clinical Cure Rate at Test of Cure (TOC) (MITT Population)
Description
Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary. Failure: Requirement of alternative antimicrobial therapy for primary infection of complicated skin and skin structure infection (cSSSI) due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI. Indeterminate: Inability to determine an outcome
Time Frame
8-15 days after last dose of study drug administration
Title
The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations.
Time Frame
8-15 days after last dose of study drug
Secondary Outcome Measure Information:
Title
To Evaluate the Microbiological Success Rate at the TOC Visit
Time Frame
8-15 days after the last dose of study drug
Title
To Evaluate the Clinical Response at the End of Therapy (EOT) Visit
Time Frame
last day of study drug administration
Title
To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit
Time Frame
8-15 days after last dose of study drug
Title
To Evaluate Clinical Relapse at the Late Follow Up (LFU) Visit
Time Frame
21 to 35 days after the last dose of study drug
Title
To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit
Time Frame
21-35 days after last dose of study drug
Title
To Evaluate Safety
Time Frame
first study drug dose through TOC

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease. Exclusion Criteria: Prior treatment of current complicated skin and skin structure infection (cSSSI) with an antimicrobial. Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Wilcox, MD
Organizational Affiliation
Old Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Investigational Site
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
Facility Name
Investigational Site
City
Hawaiian Gardens
State/Province
California
ZIP/Postal Code
90716
Country
United States
Facility Name
Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Investigational Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
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
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Facility Name
Investigational Site
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Investigational Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Investigational Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Investigational Site
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Investigational Site
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Facility Name
Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
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United States
Facility Name
Investigational Site
City
Buenos Aires
Country
Argentina
Facility Name
Investigational Site
City
Cordoba
Country
Argentina
Facility Name
Investigational Site
City
Santa Fe
Country
Argentina
Facility Name
Investigational Site
City
Braunau
Country
Austria
Facility Name
Investigational Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Investigational Site
City
St. Polten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Investigational Site
City
Sao Paula
Country
Brazil
Facility Name
Investigational Site
City
Temuco
Country
Chile
Facility Name
Investigational Site
City
Valdivia
Country
Chile
Facility Name
Investigational Site
City
Cottbus
ZIP/Postal Code
03048
Country
Germany
Facility Name
Investigational Site
City
Dortmund
ZIP/Postal Code
44145
Country
Germany
Facility Name
Investigational Site
City
Homburg/Saar
ZIP/Postal Code
D-66421
Country
Germany
Facility Name
Investigational Site
City
Mainz
ZIP/Postal Code
D-55101
Country
Germany
Facility Name
Investigational Site
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
Investigational Site
City
Riga
ZIP/Postal Code
LV-1001
Country
Latvia
Facility Name
Investigational Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Investigational Site
City
Seattle Zapopan
State/Province
Jalisco
ZIP/Postal Code
45170
Country
Mexico
Facility Name
Investigational Site
City
Bielsko-Biala
ZIP/Postal Code
43-316
Country
Poland
Facility Name
Investigational Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Investigational Site
City
Kraków
ZIP/Postal Code
31-820
Country
Poland
Facility Name
Investigational Site
City
Lodz
ZIP/Postal Code
91-425
Country
Poland
Facility Name
Investigational Site
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Investigational Site
City
Poznań
ZIP/Postal Code
61-848
Country
Poland
Facility Name
Investigational Site
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Investigational Site
City
Warszawa
ZIP/Postal Code
03-401
Country
Poland
Facility Name
Investigational Site
City
Wroclaw
ZIP/Postal Code
50-326
Country
Poland
Facility Name
Investigational Site
City
Moscow Region
ZIP/Postal Code
143405
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
119048
Country
Russian Federation
Facility Name
Investigational Site
City
St. Petersburg
ZIP/Postal Code
192242
Country
Russian Federation
Facility Name
Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Investigational Site
City
Kharkov
ZIP/Postal Code
61176
Country
Ukraine
Facility Name
Investigational Site
City
Kyiv
ZIP/Postal Code
03110
Country
Ukraine
Facility Name
Investigational Site
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Investigational Site
City
Zaporizhya
ZIP/Postal Code
69000
Country
Ukraine
Facility Name
Investigational Site
City
London
ZIP/Postal Code
N19 5LW
Country
United Kingdom
Facility Name
Investigational Site
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom

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
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
21115456
Citation
Corrado ML. Integrated safety summary of CANVAS 1 and 2 trials: Phase III, randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother. 2010 Nov;65 Suppl 4:iv67-iv71. doi: 10.1093/jac/dkq256.
Results Reference
derived
PubMed Identifier
21115455
Citation
Wilcox MH, Corey GR, Talbot GH, Thye D, Friedland D, Baculik T; CANVAS 2 investigators. CANVAS 2: the second Phase III, randomized, double-blind study evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother. 2010 Nov;65 Suppl 4:iv53-iv65. doi: 10.1093/jac/dkq255.
Results Reference
derived
PubMed Identifier
20695801
Citation
Corey GR, Wilcox M, Talbot GH, Friedland HD, Baculik T, Witherell GW, Critchley I, Das AF, Thye D. Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure infection. Clin Infect Dis. 2010 Sep 15;51(6):641-50. doi: 10.1086/655827.
Results Reference
derived

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Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections

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