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NCT Number: NCT00948142

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

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Key information

Conditions

Skin Diseases, Bacterial Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcal Skin Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chula Vista, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CEM-102

Drug

600 mg BID oral tablets for 10-14 days

Other names: fusidic acid

Linezolid

Drug

600 mg BID oral tablets

Other names: Zyvox

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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. 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

  8. 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

  9. 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.

  10. 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.

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

Arrevus Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 29, 2009
Registry last updated
Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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