- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00948142
Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Chula Vista, California, United States, 91911
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La Mesa, California, United States, 91942
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Los Angeles, California, United States, 90015
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Oceanside, California, United States, 92056
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Oxnard, California, United States, 93030
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Pasadena, California, United States, 91105
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Santa Ana, California, United States, 92701
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Torrance, California, United States, 90509
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Torrance, California, United States, 90501
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Georgia
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Columbus, Georgia, United States, 31904
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Savannah, Georgia, United States, 31406
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Illinois
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Springfield, Illinois, United States, 62701
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Michigan
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Detroit, Michigan, United States, 48202
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Montana
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Butte, Montana, United States, 59701
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New Jersey
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Somers Point, New Jersey, United States, 08244
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Ohio
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Akron, Ohio, United States, 44304
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Linezolid
600 mg BID
|
600 mg BID oral tablets
Other Names:
|
Experimental: CEM-102 Regimen A
|
600 mg BID oral tablets for 10-14 days
Other Names:
1500 mg BID oral tablets on Day 1 followed by 600 mg BID oral tablets for a total of 10-14 days
Other Names:
|
Experimental: CEM-102 Regimen B
|
600 mg BID oral tablets for 10-14 days
Other Names:
1500 mg BID oral tablets on Day 1 followed by 600 mg BID oral tablets for a total of 10-14 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Success at Test of Cure (TOC) for the intent-to-treat (ITT) population
Time Frame: 7 to 14 days after the last dose of study drug
|
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
Time Frame: 7 to 14 days after the last dose of study drug
|
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
Time Frame: 10-14 days of study drug
|
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
Time Frame: 7 to 14 days after the last dose of study drug
|
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
Time Frame: 10-14 days of study drug
|
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
Time Frame: 10-14 days of study drug
|
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
Time Frame: 10-14 days of study drug
|
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
Time Frame: 7-14 days after the last dose of study drug
|
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
Time Frame: 7-14 days after the last dose of study drug
|
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
Time Frame: 7 to 14 days after the last dose of study drug
|
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
Time Frame: 7-14 days after the last dose of study drug
|
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
Time Frame: 7-14 days after the last dose of study drug
|
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
Time Frame: 7-14 days after the last dose of study drug
|
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
Time Frame: 7-14 days after the last dose of study drug
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE06-300
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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