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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00423657
Recruitment Status : Completed
First Posted : January 18, 2007
Results First Posted : November 18, 2010
Last Update Posted : March 14, 2017
Sponsor:
Information provided by:
Forest Laboratories

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bacterial Infections Drug: ceftaroline Drug: vancomycin plus aztreonam Drug: Placebo Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Ceftaroline fosamil for Injection
Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
 Drug: ceftaroline
600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
Other Name: Experimental

Drug: Placebo
Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
Active Comparator: IV Vancomycin plus IV Aztreonam
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
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.
Other Name: Active Comparator


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Cure Rate at Test of Cure (TOC) (MITT Population) [ Time Frame: 8-15 days after last dose of study drug administration ]

    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


  2. 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 Measures :
  1. To Evaluate the Microbiological Success Rate at the TOC Visit [ Time Frame: 8-15 days after the last dose of study drug ]
  2. To Evaluate the Clinical Response at the End of Therapy (EOT) Visit [ Time Frame: last day of study drug administration ]
  3. To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit [ Time Frame: 8-15 days after last dose of study drug ]
  4. To Evaluate Clinical Relapse at the Late Follow Up (LFU) Visit [ Time Frame: 21 to 35 days after the last dose of study drug ]
  5. To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit [ Time Frame: 21-35 days after last dose of study drug ]
  6. To Evaluate Safety [ Time Frame: first study drug dose through TOC ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00423657


Locations
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Sponsors and Collaborators
Forest Laboratories
Investigators
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Principal Investigator: Mark Wilcox, MD Old Medical School
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Senior Vice President, Clinical Development, Cerexa, Inc
ClinicalTrials.gov Identifier: NCT00423657    
Other Study ID Numbers: P903-07
First Posted: January 18, 2007    Key Record Dates
Results First Posted: November 18, 2010
Last Update Posted: March 14, 2017
Last Verified: February 2017
Keywords provided by Forest Laboratories:
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
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Bacterial Infections
Disease Attributes
Pathologic Processes
Bacterial Infections and Mycoses
 Vancomycin
Ceftaroline fosamil
Aztreonam
Anti-Bacterial Agents
Anti-Infective Agents