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

NCT00423657 | Completed Phase 3 Results

• 1 other identifier: P903-07
• Study Type: interventional
• Target: 680
• Locations: 12 countries
• Sites: 54

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

  8-15 days after last dose of study drug administration

• The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations.

  8-15 days after last dose of study drug

Secondary Outcomes (6)

• To Evaluate the Microbiological Success Rate at the TOC Visit

  8-15 days after the last dose of study drug

• To Evaluate the Clinical Response at the End of Therapy (EOT) Visit

  last day of study drug administration

• To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit

  8-15 days after last dose of study drug

• To Evaluate Clinical Relapse at the Late Follow Up (LFU) Visit

  21 to 35 days after the last dose of study drug

• To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit

  21-35 days after last dose of study drug

Study Arms (2)

Ceftaroline fosamil for Injection

EXPERIMENTAL

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

Drug: ceftaroline; Drug: Placebo

IV Vancomycin plus IV Aztreonam

ACTIVE COMPARATOR

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

Drug: vancomycin plus aztreonam

Interventions

ceftaroline DRUG

600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days

Also known as: Experimental

Ceftaroline fosamil for Injection

vancomycin plus aztreonam DRUG

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.

Also known as: Active Comparator

IV Vancomycin plus IV Aztreonam

Placebo DRUG

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

Ceftaroline fosamil for Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (54)

Investigational Site

Buena Park, California, 90620, United States

Location

Investigational Site

Hawaiian Gardens, California, 90716, United States

Location

Investigational Site

Los Angeles, California, 90033, United States

Location

Investigational Site

Pasadena, California, 91105, United States

Location

Investigational Site

San Diego, California, 92114, United States

Location

Investigational Site

San Jose, California, 95124, United States

Location

Investigational Site

Atlantis, Florida, 33462, United States

Location

Investigational Site

Columbus, Georgia, 31904, United States

Location

Investigational Site

Marietta, Georgia, 30060, United States

Location

Investigational Site

Springfield, Illinois, 62701, United States

Location

Investigational Site

Baltimore, Maryland, 21201, United States

Location

Investigational Site

Minneapolis, Minnesota, 55422, United States

Location

Investigational Site

Butte, Montana, 59701, United States

Location

Investigational Site

Somers Point, New Jersey, 08244, United States

Location

Investigational Site

Toledo, Ohio, 43608, United States

Location

Investigational Site

Tacoma, Washington, 98405, United States

Location

Investigational Site

Milwaukee, Wisconsin, 53215, United States

Location

Investigational Site

Buenos Aires, Argentina

Location

Investigational Site

Córdoba, Argentina

Location

Investigational Site

Santa Fe, Argentina

Location

Investigational Site

Braunau am Inn, Austria

Location

Investigational Site

Graz, 8036, Austria

Location

Investigational Site

Sankt Pölten, 3100, Austria

Location

Investigational Site

Sao Paula, Brazil

Location

Investigational Site

Temuco, Chile

Location

Investigational Site

Valdivia, Chile

Location

Investigational Site

Cottbus, 03048, Germany

Location

Investigational Site

Dortmund, 44145, Germany

Location

Investigational Site

Homburg/Saar, D-66421, Germany

Location

Investigational Site

Mainz, D-55101, Germany

Location

Investigational Site

Wiesbaden, 65191, Germany

Location

Investigational Site

Riga, LV-1001, Latvia

Location

Investigational Site

Guadalajara, Jalisco, 44280, Mexico

Location

Investigational Site

Seattle Zapopan, Jalisco, 45170, Mexico

Location

Investigational Site

Bielsko-Biala, 43-316, Poland

Location

Investigational Site

Krakow, 31-501, Poland

Location

Investigational Site

Krakow, 31-820, Poland

Location

Investigational Site

Lodz, 91-425, Poland

Location

Investigational Site

Lublin, 20-954, Poland

Location

Investigational Site

Poznan, 61-848, Poland

Location

Investigational Site

Warsaw, 02-097, Poland

Location

Investigational Site

Warsaw, 03-401, Poland

Location

Investigational Site

Wroclaw, 50-326, Poland

Location

Investigational Site

Moscow, 111020, Russia

Location

Investigational Site

Moscow, 119048, Russia

Location

Investigational Site

Moscow Region, 143405, Russia

Location

Investigational Site

Saint Petersburg, 192242, Russia

Location

Investigational Site

Saint Petersburg, Russia

Location

Investigational Site

Kharkiv, 61176, Ukraine

Location

Investigational Site

Kyiv, 03110, Ukraine

Location

Investigational Site

Lviv, 79044, Ukraine

Location

Investigational Site

Zaporizhya, 69000, Ukraine

Location

Investigational Site

London, N19 5LW, United Kingdom

Location

Investigational Site

London, SW10 9NH, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 34922058 DERIVED

• 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.

  PMID: 34741280 DERIVED

• 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.

  PMID: 30716446 DERIVED

• 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.

  PMID: 30597021 DERIVED

• 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.

  PMID: 21115456 DERIVED

• 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.

  PMID: 21115455 DERIVED

• 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.

  PMID: 20695801 DERIVED

MeSH Terms

Conditions

Bacterial Infections; Abscess; Skin Diseases, Bacterial; Cellulitis; Staphylococcal Skin Infections; Staphylococcal Infections; Surgical Wound Infection

Interventions

Ceftaroline; Vancomycin; Aztreonam

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Suppuration; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Connective Tissue Diseases; Gram-Positive Bacterial Infections; Wound Infection; Postoperative Complications

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Monobactams; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Vice President, Clinical Sciences
• Organization: Cerexa, Inc.

clinicaltrials@cerexa.com

(510) 285-9200

Study Officials

• Mark Wilcox, MD

  Old Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 16, 2007
• First Posted: January 18, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 14, 2017
• Results First Posted: November 18, 2010

Record last verified: 2017-02

Locations

BR (1); PL (9); LA (1); UA (4); US (17); ME (2); CL (2); AR (3); RU (5); GB (2); DE (5); AU (3)