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

Primary Purpose

Bacterial Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IV Vancomycin plus IV Aztreonam
Ceftaroline
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, 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 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 for Injection

IV Vancomycin and IV Aztreonam

Arm Description

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 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
Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population

Secondary Outcome Measures

Microbiological Success Rate at the TOC Visit
Clinical Response at the End of Therapy (EOT) Visit
Clinical and Microbiological Response by Pathogen at the TOC Visit
Clinical Relapse at the Late Follow Up (LFU) Visit
Microbiological Reinfection or Recurrence at the LFU Visit
Assess Safety
Comparisons of the number of participants with Adverse Events

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
NCT00424190
Brief Title
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections
Acronym
cSSSI
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 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 the 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, 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
698 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ceftaroline for Injection
Arm Type
Experimental
Arm Title
IV Vancomycin and IV Aztreonam
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
IV Vancomycin plus IV 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)
Ceftaroline
Other Intervention Name(s)
Experimental
Intervention Description
600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
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 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 the end of treatment
Title
Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population
Time Frame
8-15 days after last dose of study drug
Secondary Outcome Measure Information:
Title
Microbiological Success Rate at the TOC Visit
Time Frame
8-15 days after last dose of study drug
Title
Clinical Response at the End of Therapy (EOT) Visit
Time Frame
Last day of study drug administration
Title
Clinical and Microbiological Response by Pathogen at the TOC Visit
Time Frame
8-15 days after last dose of study drug
Title
Clinical Relapse at the Late Follow Up (LFU) Visit
Time Frame
21 to 35 days after the last dose of study drug
Title
Microbiological Reinfection or Recurrence at the LFU Visit
Time Frame
21 to 35 days after the last dose of study drug
Title
Assess Safety
Description
Comparisons of the number of participants with Adverse Events
Time Frame
First dose of study drug through TOC visit

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 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
Ralph Corey, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Investigational Site
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36301
Country
United States
Facility Name
Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
Facility Name
Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Investigational Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
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 Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Investigational Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Investigational Site
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46280
Country
United States
Facility Name
Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Investigational Site
City
Landsdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Investigational Site
City
Buenos Aires
ZIP/Postal Code
164
Country
Argentina
Facility Name
Investigational Site
City
Buenos Aires
Country
Argentina
Facility Name
Invetigational Site
City
Buenos Aires
Country
Argentina
Facility Name
Investigational Site
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
1240 C1180AAX
Country
Argentina
Facility Name
Investigational Site
City
Cordoba
Country
Argentina
Facility Name
Invetigational Site
City
Cordoba
Country
Argentina
Facility Name
Investigational Site
City
Entre Rios
Country
Argentina
Facility Name
Investigational Site
City
Santa Fe
Country
Argentina
Facility Name
Investigational Site
City
Curiuba-Parans
ZIP/Postal Code
1089
Country
Brazil
Facility Name
Investigational Site
City
Sao Paulo
ZIP/Postal Code
04039-020
Country
Brazil
Facility Name
Investigational Site
City
Santiago
Country
Chile
Facility Name
Investigational Site
City
Vina del Mar
Country
Chile
Facility Name
Investigational Site
City
Berlin
ZIP/Postal Code
D-10249
Country
Germany
Facility Name
Investigational Site
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Investigational Site
City
Hanau
Country
Germany
Facility Name
Investigational Site
City
Plauen
ZIP/Postal Code
08529
Country
Germany
Facility Name
Investigational Site
City
Quedlinburg
ZIP/Postal Code
06484
Country
Germany
Facility Name
Investigational Site
City
Chihuahua
ZIP/Postal Code
31238
Country
Mexico
Facility Name
Invetigational Site
City
Lima
ZIP/Postal Code
29
Country
Peru
Facility Name
Investigational Site
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Investigational Site
City
Krakow
ZIP/Postal Code
31-913
Country
Poland
Facility Name
Investigational Site
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Investigational Site
City
Sosnowiec
ZIP/Postal Code
41-200
Country
Poland
Facility Name
Investigational Site
City
Todz
ZIP/Postal Code
91-425
Country
Poland
Facility Name
Investigational Site
City
Bucharest
ZIP/Postal Code
010816
Country
Romania
Facility Name
Investigational Site
City
Bucharest
ZIP/Postal Code
041915
Country
Romania
Facility Name
Investigational Site
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Investigational Site
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Investigational Site
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
Investigational Site
City
Moscow
ZIP/Postal Code
129327
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
192242
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
196247
Country
Russian Federation
Facility Name
Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49600
Country
Ukraine
Facility Name
Investigational Site
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
Investigational Site
City
Lviv
ZIP/Postal Code
79659
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
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
21115454
Citation
Corey GR, Wilcox MH, Talbot GH, Thye D, Friedland D, Baculik T; CANVAS 1 investigators. CANVAS 1: the first 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:iv41-51. doi: 10.1093/jac/dkq254.
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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