Back to resultsSafety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections
Primary Purpose
Skin Diseases, Bacterial
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CEM-102
Linezolid
CEM-102
Sponsored by
About this trial
This is an interventional treatment trial for Skin Diseases, Bacterial focused on measuring Acute Bacterial Skin and Skin Struction Infections; Bacterial Skin Diseases; Staphylococcal Skin Infections; MRSA
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Linezolid
CEM-102 Regimen A
CEM-102 Regimen B
Arm Description
600 mg BID
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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.
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.
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.
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
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.
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.
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
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
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.
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.
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00948142
Brief Title
Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arrevus Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases, Bacterial
Keywords
Acute Bacterial Skin and Skin Struction Infections; Bacterial Skin Diseases; Staphylococcal Skin Infections; MRSA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Linezolid
Arm Type
Active Comparator
Arm Description
600 mg BID
Arm Title
CEM-102 Regimen A
Arm Type
Experimental
Arm Title
CEM-102 Regimen B
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CEM-102
Other Intervention Name(s)
fusidic acid
Intervention Description
600 mg BID oral tablets for 10-14 days
Intervention Type
Drug
Intervention Name(s)
Linezolid
Other Intervention Name(s)
Zyvox
Intervention Description
600 mg BID oral tablets
Intervention Type
Drug
Intervention Name(s)
CEM-102
Other Intervention Name(s)
fusidic acid
Intervention Description
1500 mg BID oral tablets on Day 1 followed by 600 mg BID oral tablets for a total of 10-14 days
Primary Outcome Measure Information:
Title
Clinical Success at Test of Cure (TOC) for the intent-to-treat (ITT) population
Description
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
Time Frame
7 to 14 days after the last dose of study drug
Title
Clinical Success at Test of Cure (TOC) for the clinically evaluable (CE) population
Description
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
Time Frame
7 to 14 days after the last dose of study drug
Secondary Outcome Measure Information:
Title
Clinical Success at end of treatment (EOT) for the intent-to-treat (ITT) population
Description
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.
Time Frame
10-14 days of study drug
Title
Clinical Success at the test of cure (TOC) in the microbiological intent-to-treat (MITT) and population
Description
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.
Time Frame
7 to 14 days after the last dose of study drug
Title
Clinical Success at the end of treatment (EOT) for the Clinically evaluable (CE) population
Description
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.
Time Frame
10-14 days of study drug
Title
Clinical success at the end of treatment (EOT) for the microbiological intent-to-treat (MITT) population
Description
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
Time Frame
10-14 days of study drug
Title
Clinical Success at end of treatment (EOT) for the microbiologically evaluable (ME) population
Description
Meets the following definition for clinical success: complete resolution of signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required.
Time Frame
10-14 days of study drug
Title
Clinical Success at test of cure (TOC) for the microbiologically evaluable (ME) population
Description
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.
Time Frame
7-14 days after the last dose of study drug
Title
Clinical success at the test of cure (TOC) by baseline pathogen for the microbiological intent-to-treat (MITT) population
Description
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
Time Frame
7-14 days after the last dose of study drug
Title
Clinical success at test of cure (TOC) by baseline pathogen for the microbiologically evaluable (ME) population
Description
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
Time Frame
7 to 14 days after the last dose of study drug
Title
By-pathogen microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population
Description
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.
Time Frame
7-14 days after the last dose of study drug
Title
By-pathogen microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population
Description
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.
Time Frame
7-14 days after the last dose of study drug
Title
By-patient microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population
Description
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
Time Frame
7-14 days after the last dose of study drug
Title
By-patient microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population
Description
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
Time Frame
7-14 days after the last dose of study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90015
Country
United States
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90501
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21546629
Citation
Craft JC, Moriarty SR, Clark K, Scott D, Degenhardt TP, Still JG, Corey GR, Das A, Fernandes P. A randomized, double-blind phase 2 study comparing the efficacy and safety of an oral fusidic acid loading-dose regimen to oral linezolid for the treatment of acute bacterial skin and skin structure infections. Clin Infect Dis. 2011 Jun;52 Suppl 7:S520-6. doi: 10.1093/cid/cir167.
Results Reference
derived
Learn more about this trial
Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections
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