Safety and Efficacy of CEM-102 Compared to Linezolid in Acute Bacterial Skin Infections
NCT ID: NCT00948142
Last Updated: 2019-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
198 participants
INTERVENTIONAL
2009-08-31
2010-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
NCT02570490
Contezolid Acefosamil Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
NCT03747497
Clinical and Economic Outcomes of Ceftaroline Fosamil for ABSSSI Documented or at Risk of MRSA
NCT02582203
A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections
NCT01283581
Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections
NCT02569541
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Linezolid
600 mg BID
Linezolid
600 mg BID oral tablets
CEM-102 Regimen A
CEM-102
600 mg BID oral tablets for 10-14 days
CEM-102 Regimen B
CEM-102
1500 mg BID oral tablets on Day 1 followed by 600 mg BID oral tablets for a total of 10-14 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CEM-102
600 mg BID oral tablets for 10-14 days
Linezolid
600 mg BID oral tablets
CEM-102
1500 mg BID oral tablets on Day 1 followed by 600 mg BID oral tablets for a total of 10-14 days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Arrevus Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chula Vista, California, United States
La Mesa, California, United States
Los Angeles, California, United States
Oceanside, California, United States
Oxnard, California, United States
Pasadena, California, United States
Santa Ana, California, United States
Torrance, California, United States
Torrance, California, United States
Columbus, Georgia, United States
Savannah, Georgia, United States
Springfield, Illinois, United States
Detroit, Michigan, United States
Butte, Montana, United States
Somers Point, New Jersey, United States
Akron, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CE06-300
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.