Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections
Information source: Cempra Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Skin Diseases, Bacterial
Intervention: CEM-102 (Drug); Linezolid (Drug); CEM-102 (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Cempra Pharmaceuticals
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: 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
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Clinical Success at Test of Cure (TOC) for the intent-to-treat (ITT) populationClinical Success at Test of Cure (TOC) for the clinically evaluable (CE) population
Secondary outcome: Clinical Success at end of treatment (EOT) for the intent-to-treat (ITT) populationClinical Success at the test of cure (TOC) in the microbiological intent-to-treat (MITT) and population Clinical Success at the end of treatment (EOT) for the Clinically evaluable (CE) population Clinical success at the end of treatment (EOT) for the microbiological intent-to-treat (MITT) population Clinical Success at end of treatment (EOT) for the microbiologically evaluable (ME) population Clinical Success at test of cure (TOC) for the microbiologically evaluable (ME) population Clinical success at the test of cure (TOC) by baseline pathogen for the microbiological intent-to-treat (MITT) population Clinical success at test of cure (TOC) by baseline pathogen for the microbiologically evaluable (ME) population By-pathogen microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population By-pathogen microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population By-patient microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population By-patient microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Chula Vista, California 91911, United States
La Mesa, California 91942, United States
Los Angeles, California 90015, United States
Oceanside, California 92056, United States
Oxnard, California 93030, United States
Pasadena, California 91105, United States
Santa Ana, California 92701, United States
Torrance, California 90501, United States
Torrance, California 90509, United States
Columbus, Georgia 31904, United States
Savannah, Georgia 31406, United States
Springfield, Illinois 62701, United States
Detroit, Michigan 48202, United States
Butte, Montana 59701, United States
Somers Point, New Jersey 08244, United States
Akron, Ohio 44304, United States
Additional Information
Starting date: August 2009
Last updated: September 15, 2011
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