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

Sponsor:	Cempra Pharmaceuticals
Information provided by:	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
Acute Bacterial Skin Structure Infections	Drug: CEM-102 Drug: Linezolid	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	An Adaptive Design, 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:

Drug Information available for: Linezolid

U.S. FDA Resources

Further study details as provided by Cempra Pharmaceuticals:

Primary Outcome Measures:

Clinical Success rates in the clinically evaluable (CE) and Intent-to-Treat (ITT) patient populations at the test of cure (TOC) visit. [ Time Frame: 16 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Response in the Microbiological ITT (MITT), CE, and Microbiologically Evaluable (ME) populations at end of treatment (EOT) [ Time Frame: 16 months ] [ Designated as safety issue: No ]
Clinical Response in the MITT and ME populations at TOC [ Time Frame: 16 months ] [ Designated as safety issue: No ]
By patient and by pathogen Microbiological Response in the MITT and ME populations at EOT and TOC [ Time Frame: 16 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	880
Study Start Date:	August 2009
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Linezolid: Active Comparator 600 mg BID	Drug: Linezolid BID
CEM-102 Regimen A: Experimental Regimen A BID	Drug: CEM-102 BID
CEM-102 Regimen B: Experimental Regimen B BID	Drug: CEM-102 BID

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 all 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).
Infection which in the opinion of the investigator will require 10-14 days of antibacterial therapy.
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.
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.
Participation in any study involving use of an investigational drug or device (i.e. a drug or device without an FDA or Health Canada approved indication) within the 30 previous days.

Contacts and Locations

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

Contacts

Contact: Kay Clark, RN, BSHA

315-224-4901

kclark@cempra.com

Locations

United States, California
	Recruiting
Santa Ana, California, United States
	Recruiting
Chula Vista, California, United States
	Recruiting
Torrance, California, United States
	Recruiting
La Mesa, California, United States
	Recruiting
Los Angeles, California, United States
	Recruiting
Oxnard, California, United States
	Recruiting
Pasadena, California, United States
	Recruiting
Oceanside, California, United States
United States, Georgia
	Recruiting
Columbus, Georgia, United States
	Recruiting
Savannah, Georgia, United States
United States, Michigan
	Recruiting
Detroit, Michigan, United States
United States, Minnesota
	Recruiting
Minneapolis, Minnesota, United States
United States, Montana
	Recruiting
Butte, Montana, United States
United States, New Jersey
	Recruiting
Somers Point, New Jersey, United States

Sponsors and Collaborators

Cempra Pharmaceuticals

More Information

No publications provided

Responsible Party:	Cempra Pharmaceuticals ( J. Gordon Still/Chief Medical Officer )
Study ID Numbers:	CE06-300
Study First Received:	July 28, 2009
Last Updated:	September 10, 2009
ClinicalTrials.gov Identifier:	NCT00948142 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Protein Synthesis Inhibitors
Anti-Infective Agents
Communicable Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Infection
Linezolid
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010