Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections
Information source: Cempra Pharmaceuticals
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Bacterial Skin Structure Infections
Intervention: CEM-102 (Drug); Linezolid (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Cempra Pharmaceuticals Overall contact:
Kay Clark, RN, BSHA, Phone: 315-224-4901, Email: kclark@cempra.com
Summary
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).
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Primary outcome: Clinical Success rates in the clinically evaluable (CE) and Intent-to-Treat (ITT) patient populations at the test of cure (TOC) visit.
Secondary outcome: Clinical Response in the Microbiological ITT (MITT), CE, and Microbiologically Evaluable (ME) populations at end of treatment (EOT)Clinical Response in the MITT and ME populations at TOC By patient and by pathogen Microbiological Response in the MITT and ME populations at EOT and TOC
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Kay Clark, RN, BSHA, Phone: 315-224-4901, Email: kclark@cempra.com
Santa Ana, California, United States; Recruiting
Chula Vista, California, United States; Recruiting
Torrance, California, United States; Recruiting
Pasadena, California, United States; Recruiting
Los Angeles, California, United States; Recruiting
Oxnard, California, United States; Recruiting
La Mesa, California, United States; Recruiting
Oceanside, California, United States; Recruiting
Columbus, Georgia, United States; Recruiting
Savannah, Georgia, United States; Recruiting
Detroit, Michigan, United States; Recruiting
Minneapolis, Minnesota, United States; Recruiting
Butte, Montana, United States; Recruiting
Somers Point, New Jersey, United States; Recruiting
Additional Information
Starting date: August 2009
Last updated: September 10, 2009
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