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

Study Overview
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Brief Summary
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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
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Additional purpose of this study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.

Official Title
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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)

Conditions
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Bacterial Infections

Intervention / Treatment
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* Drug: ceftaroline
* Drug: vancomycin plus aztreonam
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ceftaroline fosamil for Injection<br>Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours. | Drug: ceftaroline<br>* 600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days<br>* Other names: Experimental;Drug: Placebo<br>* Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.<br>|
| Active Comparator: IV Vancomycin plus IV Aztreonam<br>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<br>* 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.<br>* Other names: Active Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| To Evaluate Safety |  | first study drug dose through TOC | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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