Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections
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
1 other identifier
interventional
198
1 country
16
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2009
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2009
CompletedFirst Posted
Study publicly available on registry
July 29, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedApril 19, 2019
April 1, 2019
7 months
July 28, 2009
April 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinical Success at Test of Cure (TOC) for the intent-to-treat (ITT) population
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
7 to 14 days after the last dose of study drug
Clinical Success at Test of Cure (TOC) for the clinically evaluable (CE) population
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
7 to 14 days after the last dose of study drug
Secondary Outcomes (12)
Clinical Success at end of treatment (EOT) for the intent-to-treat (ITT) population
10-14 days of study drug
Clinical Success at the test of cure (TOC) in the microbiological intent-to-treat (MITT) and population
7 to 14 days after the last dose of study drug
Clinical Success at the end of treatment (EOT) for the Clinically evaluable (CE) population
10-14 days of study drug
Clinical success at the end of treatment (EOT) for the microbiological intent-to-treat (MITT) population
10-14 days of study drug
Clinical Success at end of treatment (EOT) for the microbiologically evaluable (ME) population
10-14 days of study drug
- +7 more secondary outcomes
Study Arms (3)
Linezolid
ACTIVE COMPARATOR600 mg BID
CEM-102 Regimen A
EXPERIMENTALCEM-102 Regimen B
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arrevus Inc.lead
Study Sites (16)
Unknown Facility
Chula Vista, California, 91911, United States
Unknown Facility
La Mesa, California, 91942, United States
Unknown Facility
Los Angeles, California, 90015, United States
Unknown Facility
Oceanside, California, 92056, United States
Unknown Facility
Oxnard, California, 93030, United States
Unknown Facility
Pasadena, California, 91105, United States
Unknown Facility
Santa Ana, California, 92701, United States
Unknown Facility
Torrance, California, 90501, United States
Unknown Facility
Torrance, California, 90509, United States
Unknown Facility
Columbus, Georgia, 31904, United States
Unknown Facility
Savannah, Georgia, 31406, United States
Unknown Facility
Springfield, Illinois, 62701, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Butte, Montana, 59701, United States
Unknown Facility
Somers Point, New Jersey, 08244, United States
Unknown Facility
Akron, Ohio, 44304, United States
Related Publications (1)
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. doi: 10.1093/cid/cir167.
PMID: 21546629DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2009
First Posted
July 29, 2009
Study Start
August 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
April 19, 2019
Record last verified: 2019-04