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

April 15, 2019 updated by: Arrevus Inc.

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
198

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
      • La Mesa, California, United States, 91942
      • Los Angeles, California, United States, 90015
      • Oceanside, California, United States, 92056
      • Oxnard, California, United States, 93030
      • Pasadena, California, United States, 91105
      • Santa Ana, California, United States, 92701
      • Torrance, California, United States, 90509
      • Torrance, California, United States, 90501
    • Georgia
      • Columbus, Georgia, United States, 31904
      • Savannah, Georgia, United States, 31406
    • Illinois
      • Springfield, Illinois, United States, 62701
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Montana
      • Butte, Montana, United States, 59701
    • New Jersey
      • Somers Point, New Jersey, United States, 08244
    • Ohio
      • Akron, Ohio, United States, 44304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Linezolid
600 mg BID
Drug: Linezolid
600 mg BID oral tablets
Other Names:
  • Zyvox
Experimental: CEM-102 Regimen A
Drug: CEM-102
600 mg BID oral tablets for 10-14 days
Other Names:
  • fusidic acid
Drug: CEM-102
1500 mg BID oral tablets on Day 1 followed by 600 mg BID oral tablets for a total of 10-14 days
Other Names:
  • fusidic acid
Experimental: CEM-102 Regimen B
Drug: CEM-102
600 mg BID oral tablets for 10-14 days
Other Names:
  • fusidic acid
Drug: CEM-102
1500 mg BID oral tablets on Day 1 followed by 600 mg BID oral tablets for a total of 10-14 days
Other Names:
  • fusidic acid

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arrevus Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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