Status:
COMPLETED
Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections
Lead Sponsor:
Arrevus Inc.
Conditions:
Skin Diseases, Bacterial
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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).
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. Th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00948142
Start Date
August 1 2009
End Date
March 1 2010
Last Update
April 19 2019
Active Locations (16)
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1
Chula Vista, California, United States, 91911
2
La Mesa, California, United States, 91942
3
Los Angeles, California, United States, 90015
4
Oceanside, California, United States, 92056