Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections (cSSSI)
|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: NCT00424190|
Recruitment Status : Completed
First Posted : January 18, 2007
Results First Posted : November 7, 2010
Last Update Posted : March 14, 2017
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Infections||Drug: IV Vancomycin plus IV Aztreonam Drug: Ceftaroline||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||698 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||February 2007|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
|Experimental: Ceftaroline for Injection||
600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
Other Name: Experimental
|Active Comparator: IV Vancomycin and IV Aztreonam||
Drug: IV Vancomycin plus IV 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
- Clinical Cure Rate at Test of Cure (TOC) (MITT Population) [ Time Frame: 8-15 days after the end of treatment ]
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 [ Time Frame: 8-15 days after last dose of study drug ]
- Microbiological Success Rate at the TOC Visit [ Time Frame: 8-15 days after last dose of study drug ]
- Clinical Response at the End of Therapy (EOT) Visit [ Time Frame: Last day of study drug administration ]
- Clinical and Microbiological Response by Pathogen at the TOC Visit [ Time Frame: 8-15 days after last dose of study drug ]
- Clinical Relapse at the Late Follow Up (LFU) Visit [ Time Frame: 21 to 35 days after the last dose of study drug ]
- Microbiological Reinfection or Recurrence at the LFU Visit [ Time Frame: 21 to 35 days after the last dose of study drug ]
- Assess Safety [ Time Frame: First dose of study drug through TOC visit ]Comparisons of the number of participants with Adverse Events
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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): NCT00424190
|Principal Investigator:||Ralph Corey, MD||Duke University|
|Responsible Party:||Senior Vice President, Clinical Development, Cerexa, Inc|
|Other Study ID Numbers:||
|First Posted:||January 18, 2007 Key Record Dates|
|Results First Posted:||November 7, 2010|
|Last Update Posted:||March 14, 2017|
|Last Verified:||February 2017|
Bacterial infection, skin
Complicated skin and skin structure infection
Methicillin-resistant Staphylococcus Aureus (MRSA)
Skin disease, bacterial
Staphylococcal skin infection
Streptococcal skin infection
Surgical site infection
Bacterial Infections and Mycoses