Clinical trial NCT00424190: 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
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
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: 698
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 the 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 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 the end of treatment
measure: Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population
timeFrame: 8-15 days after last dose of study drug
Secondary outcomes:
measure: Microbiological Success Rate at the TOC Visit
timeFrame: 8-15 days after last dose of study drug
measure: Clinical Response at the End of Therapy (EOT) Visit
timeFrame: Last day of study drug administration
measure: Clinical and Microbiological Response by Pathogen at the TOC Visit
timeFrame: 8-15 days after last dose of study drug
measure: Clinical Relapse at the Late Follow Up (LFU) Visit
timeFrame: 21 to 35 days after the last dose of study drug
measure: Microbiological Reinfection or Recurrence at the LFU Visit
timeFrame: 21 to 35 days after the last dose of study drug
measure: Assess Safety
timeFrame: First dose of study drug through TOC visit
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Investigational Site
state: Alabama
city: Long Beach
country: United States
facility: Investigational Site
state: California
city: Los Angeles
country: United States
facility: Investigational Site
state: California
city: Sacramento
country: United States
facility: Investigational Site
state: California
city: Sacramento
country: United States
facility: Investigational Site
state: California
city: San Diego
country: United States
facility: Investigational Site
state: California
city: San Francisco
country: United States
facility: Investigational Site
state: California
city: Torrance
country: United States
facility: Investigational Site
state: California
city: Savannah
country: United States
facility: Investigational Site
state: Georgia
city: Naperville
country: United States
facility: Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Investigational Site
state: Indiana
city: Shreveport
country: United States
facility: Investigational Site
state: Louisiana
city: Columbus
country: United States
facility: Investigational Site
state: Ohio
city: Landsdale
country: United States
facility: Investigational Site
state: Pennsylvania
city: Tacoma
country: United States
facility: Investigational Site
state: Washington
city: Buenos Aires
country: Argentina
facility: Investigational Site
city: Buenos Aires
country: Argentina
facility: Investigational Site
city: Buenos Aires
country: Argentina
facility: Invetigational Site
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Investigational Site
city: Cordoba
country: Argentina
facility: Investigational Site
city: Cordoba
country: Argentina
facility: Invetigational Site
city: Entre Rios
country: Argentina
facility: Investigational Site
city: Santa Fe
country: Argentina
facility: Investigational Site
city: Curiuba-Parans
country: Brazil
facility: Investigational Site
city: Sao Paulo
country: Brazil
facility: Investigational Site
city: Santiago
country: Chile
facility: Investigational Site
city: Vina del Mar
country: Chile
facility: Investigational Site
city: Berlin
country: Germany
facility: Investigational Site
city: Bochum
country: Germany
facility: Investigational Site
city: Hanau
country: Germany
facility: Investigational Site
city: Plauen
country: Germany
facility: Investigational Site
city: Quedlinburg
country: Germany
facility: Investigational Site
city: Chihuahua
country: Mexico
facility: Investigational Site
city: Lima
country: Peru
facility: Invetigational Site
city: Bytom
country: Poland
facility: Investigational Site
city: Krakow
country: Poland
facility: Investigational Site
city: Lublin
country: Poland
facility: Investigational Site
city: Sosnowiec
country: Poland
facility: Investigational Site
city: Todz
country: Poland
facility: Investigational Site
city: Bucharest
country: Romania
facility: Investigational Site
city: Bucharest
country: Romania
facility: Investigational Site
city: Timisoara
country: Romania
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: Smolensk
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: St. Petersburg
country: Russian Federation
facility: Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: Investigational Site
city: Lviv
country: Ukraine
facility: Investigational Site
Study officials:
affiliation: Duke University
name: Ralph Corey, 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: 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.
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.