Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and efficacy of CEM-102 compared to Linezolid in the treatment of acute bacterial skin structure infections (ABSSIs).

Detailed Description
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ABSSIs are common and affect all age groups. In recent years, ABSSIs caused by multi-drug resistant pathogens, especially methicillin-resistant Staphylococcus aureus (MRSA) have become more common. There is an urgent need for additional antibacterial drugs with modes of action different from those currently available. CEM-102 is one such agent with excellent activity against S. aureus, including MRSA.

Official Title
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A Phase 2, Randomized, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of CEM-102 Compared to Linezolid in the Treatment of Acute Bacterial Skin Structure Infections

Conditions
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Skin Diseases, Bacterial

Intervention / Treatment
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* Drug: CEM-102
* Drug: Linezolid
* Drug: CEM-102


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of acute bacterial skin-structure infection (ABSSI) of no more than 7 days duration which was suspected or proven to be caused, at least in part, by a gram-positive pathogen. Eligible infections included cellulitis measuring at least 10 cm length and width or 100 cm squared, with or without a focal abscess, and surgical or traumatic wound infections Infection which in the opinion of the investigator will require 10-14 days of antibacterial therapy. Have at least 3 of the following local and/or systemic symptoms and/or signs of infection: purulent or seropurulent drainage/discharge, erythema, fluctuance, heat/localized warmth, pain/tenderness to palpation, swelling/induration, regional lymph node swelling or tenderness, temperature >=100.4 degree F, increased white blood cell count, or bandemia. Must not have received treatment with another systemic antibiotic for the current ABSSI. Exclusion Criteria: Superficial skin structure infections such as folliculitis, carbuncles, furunculosis, cutaneous abscesses, and simple cellulitis. Infections involving burns, human or animal bites, or chronic diabetic foot ulcers. Suspected polymicrobial infection involving Pseudomonas aeruginosa Anticipated need for >14 days of antibiotic therapy. Infections complicated by the presence of prosthetic materials that will not be removed, such as permanent cardiac pacemaker battery packs, mesh, or joint replacement prosthesis. Known significant renal, hepatic, or hematologic impairment. Received prior potentially effective antimicrobial therapy for the acute bacterial skin and skin structure infection, unless they were failing therapy after 48 hours or had a gram-positive pathogen non-susceptible to prior therapy identified as a causative pathogen.

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 |
| --- | --- |
| Active Comparator: Linezolid<br>600 mg BID | Drug: Linezolid<br>* 600 mg BID oral tablets<br>* Other names: Zyvox;|
| Experimental: CEM-102 Regimen A<br> | Drug: CEM-102<br>* 600 mg BID oral tablets for 10-14 days<br>* Other names: fusidic acid;|
| Experimental: CEM-102 Regimen B<br> | Drug: CEM-102<br>* 1500 mg BID oral tablets on Day 1 followed by 600 mg BID oral tablets for a total of 10-14 days<br>* Other names: fusidic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success at Test of Cure (TOC) for the intent-to-treat (ITT) population | Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required | 7 to 14 days after the last dose of study drug | 
| Clinical Success at Test of Cure (TOC) for the clinically evaluable (CE) population | Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required | 7 to 14 days after the last dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success at end of treatment (EOT) for the intent-to-treat (ITT) population | Meets the following definition for clinical success: Complete resolution of the signs and symptoms of the ABSSI and no further study drug therapy is required. | 10-14 days of study drug | 
| Clinical Success at the test of cure (TOC) in the microbiological intent-to-treat (MITT) and population | Meets the following definition for clinical success: Complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required. | 7 to 14 days after the last dose of study drug | 
| Clinical Success at the end of treatment (EOT) for the Clinically evaluable (CE) population | Meets the following definition for clinical success: complete resolution of the signs and symptoms of the ABSSI and no further study drug therapy is required. | 10-14 days of study drug | 
| Clinical success at the end of treatment (EOT) for the microbiological intent-to-treat (MITT) population | Meets the following definition for clinical success at the end of treatment: complete resolutoin of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required | 10-14 days of study drug | 
| Clinical Success at end of treatment (EOT) for the microbiologically evaluable (ME) population | Meets the following definition for clinical success: complete resolution of signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required. | 10-14 days of study drug | 
| Clinical Success at test of cure (TOC) for the microbiologically evaluable (ME) population | Meets the following definition of clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required. | 7-14 days after the last dose of study drug | 
| Clinical success at the test of cure (TOC) by baseline pathogen for the microbiological intent-to-treat (MITT) population | Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additonal systemic antibacterial therapy is required | 7-14 days after the last dose of study drug | 
| Clinical success at test of cure (TOC) by baseline pathogen for the microbiologically evaluable (ME) population | Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required | 7 to 14 days after the last dose of study drug | 
| By-pathogen microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population | Successful responses included: eradication: the basline causative pathogen was absent from the culture(s) presumed eradication: the patient's clincial response was success, and no culture available. | 7-14 days after the last dose of study drug | 
| By-pathogen microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population | Successful responses included: eradication: the basline causative pathogen was absent from the culture(s) presumed eradication: the patient's clincial response was success, and no culture available. | 7-14 days after the last dose of study drug | 
| By-patient microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population | Successful responses included: eradication: the baseline causative organisms have a response of eradication. presumed eradication: all baseline causative organism(s) have a response of presumed eradication combined eradication/presumed eradication: in cases where baseline causative organisms were from a blood and an ABSSI culture | 7-14 days after the last dose of study drug | 
| By-patient microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population | Successful responses included: eradication: the baseline causative organisms have a response of eradication. presumed eradication: all baseline causative organism(s) have a response of presumed eradication combined eradication/presumed eradication: in cases where baseline causative organisms were from a blood and an ABSSI culture | 7-14 days after the last dose of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Bacterial Skin and Skin Struction Infections; Bacterial Skin Diseases; Staphylococcal Skin Infections; MRSA