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

Sponsor:	Cempra Pharmaceuticals
Information provided by (Responsible Party):	Cempra Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00948142

Purpose

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).

Condition	Intervention	Phase
Skin Diseases, Bacterial	Drug: CEM-102 Drug: Linezolid	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Skin Conditions Skin Infections

Drug Information available for: Linezolid Fusidate Sodium Fusidic acid

U.S. FDA Resources

Further study details as provided by Cempra Pharmaceuticals:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 [ Time Frame: 7 to 14 days after the last dose of study drug ] [ Designated as safety issue: No ]
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 [ Time Frame: 10-14 days of study drug ] [ Designated as safety issue: No ]
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 [ Time Frame: 7 to 14 days after the last dose of study drug ] [ Designated as safety issue: No ]
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 [ Time Frame: 10-14 days of study drug ] [ Designated as safety issue: No ]
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 [ Time Frame: 10-14 days of study drug ] [ Designated as safety issue: No ]
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 [ Time Frame: 10-14 days of study drug ] [ Designated as safety issue: No ]
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 [ Time Frame: 7-14 days after the last dose of study drug ] [ Designated as safety issue: No ]
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 [ Time Frame: 7-14 days after the last dose of study drug ] [ Designated as safety issue: No ]
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 [ Time Frame: 7 to 14 days after the last dose of study drug ] [ Designated as safety issue: No ]
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 [ Time Frame: 7-14 days after the last dose of study drug ] [ Designated as safety issue: No ]
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 [ Time Frame: 7-14 days after the last dose of study drug ] [ Designated as safety issue: No ]
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 [ Time Frame: 7-14 days after the last dose of study drug ] [ Designated as safety issue: No ]
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 [ Time Frame: 7-14 days after the last dose of study drug ] [ Designated as safety issue: No ]
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

Enrollment:	198
Study Start Date:	August 2009
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Linezolid 600 mg BID	Drug: Linezolid 600 mg BID oral tablets Other Name: Zyvox
Experimental: CEM-102 Regimen A	Drug: CEM-102 600 mg BID oral tablets for 10-14 days Other Name: fusidic acid
Experimental: CEM-102 Regimen B	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 Name: fusidic acid

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948142

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
United States, Georgia

Columbus, Georgia, United States, 31904

Savannah, Georgia, United States, 31406
United States, Illinois

Springfield, Illinois, United States, 62701
United States, Michigan

Detroit, Michigan, United States, 48202
United States, Montana

Butte, Montana, United States, 59701
United States, New Jersey

Somers Point, New Jersey, United States, 08244
United States, Ohio

Akron, Ohio, United States, 44304

Sponsors and Collaborators

Cempra Pharmaceuticals

More Information

No publications provided by Cempra Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Cempra Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00948142 History of Changes
Other Study ID Numbers:	CE06-300
Study First Received:	July 28, 2009
Last Updated:	September 15, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cempra Pharmaceuticals:

Acute Bacterial Skin and Skin Struction Infections; Bacterial Skin Diseases; Staphylococcal Skin Infections; MRSA

Additional relevant MeSH terms:

Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Bacterial
Infection
Bacterial Infections
Fusidic Acid
Linezolid

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012