Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections
This study has been completed.
Sponsor:
Cerexa, Inc.
Information provided by (Responsible Party):
Cerexa, Inc.
ClinicalTrials.gov Identifier:
NCT00633152
First received: March 3, 2008
Last updated: October 9, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults.
| Condition | Intervention | Phase |
|---|---|---|
|
Bacterial Infection |
Drug: ceftaroline Drug: linezolid Drug: Aztreonam |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2, Multicenter, Randomized, Open-label, Comparative Study to Evaluate the Efficacy and Safety of Intramuscular Ceftaroline Versus Intravenous Linezolid in Adult Subjects With Complicated Skin and Skin Structure Infections |
Resource links provided by NLM:
Further study details as provided by Cerexa, Inc.:
Primary Outcome Measures:
- Clinical Response at the Test of Cure (TOC) Visit in the Modified Intent-to-treat (MITT) Population [ Time Frame: Test of Cure Visit (8 to 15 days after end of therapy) ] [ Designated as safety issue: No ]The coprimary efficacy outcome measures were the per-subject clinical cure rate at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) and (Modified-Intent-to-Treat) MITT Populations. Subjects were considered clinically cured at the Test of Cure (TOC) Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.
- Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population [ Time Frame: Test of Cure Visit (8 to 15 Days after end of therapy) ] [ Designated as safety issue: No ]The coprimary efficacy outcome measures were the per-subject clinical cure rate at the TOC Visit in the CE and MITT Populations. Subjects were considered clinically cured at the TOC Visit if they had total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy was necessary.
Secondary Outcome Measures:
- Clinical Cure Rate at the TOC Visit in the cMITT Population [ Time Frame: TOC Visit (8 to 15 days after end of therapy) ] [ Designated as safety issue: No ]Evaluate per-subject the clinical response at the Test-of-Cure (TOC) Visit in the Clinical Modified Intent-to-treat (cMITT) Population.
- Clinical Response at the End-of-Therapy (EOT) Visit in the MITT, cMITT and CE Populations. [ Time Frame: End-of-therapy (EOT) visit ] [ Designated as safety issue: No ]Evaluate per-subject the clinical response at the End-of-therapy (EOT) Visit in the MITT, cMITT and CE populations.
- The Microbiological Response at the TOC Visit in the mMITT and ME Populations. [ Time Frame: TOC Visit (8 to 15 days after end of therapy) ] [ Designated as safety issue: No ]Evaluate per-subject the microbiological response at the TOC Visit in the Microbiological Modified Intent-to-treat (mMITT) and Microbiologically Evaluable (ME) populations.
- Clinical and Microbiological Response by Pathogen at the TOC Visit in the mMITT and ME Populations [ Time Frame: TOC Visit (8 to 15 days after end of therapy) ] [ Designated as safety issue: No ]Evaluate the clinical and microbiological response by pathogen at the TOC Visit in the mMITT and ME populations.
- Clinical Relapse at the Late Follow-up Visit [ Time Frame: Late Follow-up (LFU) Visit (21 to 35 days after end of therapy) ] [ Designated as safety issue: No ]Evaluate Clinical relapse rate at Late Follow-up (LFU) (21 to 45 days after the final dose of study drug)in those subjects clinically cured at the TOC visit.
- The Microbiological Reinfection or Recurrence at the Late Follow-up (LFU) Visit [ Time Frame: LFU Visit (21 to 35 days after end of therapy) ] [ Designated as safety issue: No ]Evaluate per-subject reinfection or recurrence rate at the LFU Visit in those subjects who had a favorable microbiological outcome (eradication or presumed eradication) at the TOC Visit.
- The Safety of Ceftaroline Fosamil [ Time Frame: First dose of study drug through LFU Visit or 30 days after the last dose of study drug ] [ Designated as safety issue: Yes ]Evaluate safety of Ceftaroline fosamil IM in adults with cSSSI
| Enrollment: | 150 |
| Study Start Date: | February 2008 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ceftaroline
Intramuscular every 12 hours
|
Drug: ceftaroline
600 mg injected every 12 hours for at least 5 but not more than 14 days
Other Names:
|
|
Active Comparator: linezolid plus optional aztreonam
Intravenous every 12 hours
|
Drug: linezolid
600 mg parenteral infused over 60 minutes for a minimum of 5 days and a maximum of 14 days
Other Names:
Drug: Aztreonam
1000 mg infused over 60 minutes every 24 hours may be started with linezolid or added later (up to 72 hours after the first dose of linezolid) for subjects with a gram-negative infection indicated.
|
Detailed Description:
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults. The primary focus is bacterial infection.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Complicated skin and skin structure infection (cSSSI)
- Require initial hospitalization, or treatment in an emergency room or urgent care setting
Exclusion Criteria:
- Hypersensitivity or allergic reaction to any ß-lactam, ceftaroline, linezolid, aztreonam, or to their components
- Concomitant use of adrenergic or serotonergic agent
- Uncomplicated skin and skin structure infection
- Concomitant therapy with any drug known to exhibit a contraindicated drug-drug interaction
- More than 24 hours of treatment with an antimicrobial within 96 hours before randomization
- Known or suspected endocarditis, osteomyelitis, or septic arthritis
- Severely impaired renal function
- Evidence of significant hepatic, hematologic, or immunologic disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633152
Locations
| United States, California | |
| Investigational Site | |
| Buena Park, California, United States, 96020 | |
| Investigational Site | |
| Long Beach, California, United States, 90813 | |
| Investigational Site | |
| Los Angeles, California, United States, 90015 | |
| Investigational Site | |
| Rolling Hills Estate, California, United States, 90274 | |
| Investigational Site | |
| San Diego, California, United States, 92114 | |
| United States, Florida | |
| Investigational Site | |
| Atlantis, Florida, United States, 33462 | |
| United States, Georgia | |
| Investigational Site | |
| Columbus, Georgia, United States, 31904 | |
| Investigational Site | |
| Savannah, Georgia, United States, 31405 | |
| United States, Minnesota | |
| Investigational Site | |
| Minneapolis, Minnesota, United States, 55422 | |
| United States, Montana | |
| Investigational Site | |
| Butte, Montana, United States, 59701 | |
| United States, New Jersey | |
| Investigational Site | |
| Somers Point, New Jersey, United States, 08244 | |
| United States, Ohio | |
| Investigational Site | |
| Columbus, Ohio, United States, 43215 | |
| Investigational Site | |
| Toledo, Ohio, United States, 43608 | |
Sponsors and Collaborators
Cerexa, Inc.
Investigators
| Study Director: | Medical Monitor Cerexa | Cerexa, Inc. |
More Information
No publications provided
| Responsible Party: | Cerexa, Inc. |
| ClinicalTrials.gov Identifier: | NCT00633152 History of Changes |
| Other Study ID Numbers: | P903-19 |
| Study First Received: | March 3, 2008 |
| Results First Received: | July 25, 2012 |
| Last Updated: | October 9, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Cerexa, Inc.:
|
complicated skin and skin structure infections linezolid ceftaroline clinical response microbiological response Cellulitis Abscess Wound infection |
Deeper soft tissue Significant surgical intervention Gram-positive bacterial infection Gram-negative bacterial infection bacterial infection cephalosporin broad-spectrum activity |
Additional relevant MeSH terms:
|
Bacterial Infections Aztreonam Linezolid Anti-Bacterial Agents Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013