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

Completed

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

Interventional

Enrollment (Actual)

198

Phase

  • 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

    • 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

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
Intervention / Treatment
Active Comparator: Linezolid
600 mg BID
600 mg BID oral tablets
Other Names:
  • Zyvox
Experimental: CEM-102 Regimen A
600 mg BID oral tablets for 10-14 days
Other Names:
  • fusidic acid
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
600 mg BID oral tablets for 10-14 days
Other Names:
  • fusidic acid
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

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

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

Sponsor

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.

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

August 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

July 28, 2009

First Submitted That Met QC Criteria

July 28, 2009

First Posted (Estimate)

July 29, 2009

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

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.

Clinical Trials on Skin Diseases, Bacterial

Clinical Trials on Linezolid

3
Subscribe