Clinical trial NCT00423657: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2007-01-18
Enrollment: 680
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical Cure Rate at Test of Cure (TOC) (MITT Population)
timeFrame: 8-15 days after last dose of study drug administration
measure: The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations.
timeFrame: 8-15 days after last dose of study drug
Secondary outcomes:
measure: To Evaluate the Microbiological Success Rate at the TOC Visit
timeFrame: 8-15 days after the last dose of study drug
measure: To Evaluate the Clinical Response at the End of Therapy (EOT) Visit
timeFrame: last day of study drug administration
measure: To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit
timeFrame: 8-15 days after last dose of study drug
measure: To Evaluate Clinical Relapse at the Late Follow Up (LFU) Visit
timeFrame: 21 to 35 days after the last dose of study drug
measure: To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit
timeFrame: 21-35 days after last dose of study drug
measure: To Evaluate Safety
timeFrame: first study drug dose through TOC
Other outcomes:
Locations:
city: Buena Park
country: United States
facility: Investigational Site
state: California
city: Hawaiian Gardens
country: United States
facility: Investigational Site
state: California
city: Los Angeles
country: United States
facility: Investigational Site
state: California
city: Pasadena
country: United States
facility: Investigational Site
state: California
city: San Diego
country: United States
facility: Investigational Site
state: California
city: San Jose
country: United States
facility: Investigational Site
state: California
city: Atlantis
country: United States
facility: Investigational Site
state: Florida
city: Columbus
country: United States
facility: Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Investigational Site
state: Georgia
city: Springfield
country: United States
facility: Investigational Site
state: Illinois
city: Baltimore
country: United States
facility: Investigational Site
state: Maryland
city: Minneapolis
country: United States
facility: Investigational Site
state: Minnesota
city: Butte
country: United States
facility: Investigational Site
state: Montana
city: Somers Point
country: United States
facility: Investigational Site
state: New Jersey
city: Toledo
country: United States
facility: Investigational Site
state: Ohio
city: Tacoma
country: United States
facility: Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Investigational Site
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Investigational Site
city: Cordoba
country: Argentina
facility: Investigational Site
city: Santa Fe
country: Argentina
facility: Investigational Site
city: Braunau
country: Austria
facility: Investigational Site
city: Graz
country: Austria
facility: Investigational Site
city: St. Polten
country: Austria
facility: Investigational Site
city: Sao Paula
country: Brazil
facility: Investigational Site
city: Temuco
country: Chile
facility: Investigational Site
city: Valdivia
country: Chile
facility: Investigational Site
city: Cottbus
country: Germany
facility: Investigational Site
city: Dortmund
country: Germany
facility: Investigational Site
city: Homburg/Saar
country: Germany
facility: Investigational Site
city: Mainz
country: Germany
facility: Investigational Site
city: Wiesbaden
country: Germany
facility: Investigational Site
city: Riga
country: Latvia
facility: Investigational Site
city: Guadalajara
country: Mexico
facility: Investigational Site
state: Jalisco
city: Seattle Zapopan
country: Mexico
facility: Investigational Site
state: Jalisco
city: Bielsko-Biala
country: Poland
facility: Investigational Site
city: Krakow
country: Poland
facility: Investigational Site
city: Kraków
country: Poland
facility: Investigational Site
city: Lodz
country: Poland
facility: Investigational Site
city: Lublin
country: Poland
facility: Investigational Site
city: Poznań
country: Poland
facility: Investigational Site
city: Warszawa
country: Poland
facility: Investigational Site
city: Warszawa
country: Poland
facility: Investigational Site
city: Wroclaw
country: Poland
facility: Investigational Site
city: Moscow Region
country: Russian Federation
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Investigational Site
city: Kharkov
country: Ukraine
facility: Investigational Site
city: Kyiv
country: Ukraine
facility: Investigational Site
city: Lviv
country: Ukraine
facility: Investigational Site
city: Zaporizhya
country: Ukraine
facility: Investigational Site
city: London
country: United Kingdom
facility: Investigational Site
city: London
country: United Kingdom
facility: Investigational Site
Study officials:
affiliation: Old Medical School
name: Mark Wilcox, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.