Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
A Randomized, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of Oral Sodium Fusidate (CEM-102) Compared to Oral Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infections
1 other identifier
interventional
716
2 countries
62
Brief Summary
Phase 3, randomized, double-blind, multi-center efficacy and safety study to evaluate an oral CEM-102 loading dose regimen compared to oral linezolid in the treatment of subjects with ABSSSI
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2015
Shorter than P25 for phase_3
62 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
October 5, 2015
CompletedFirst Posted
Study publicly available on registry
October 7, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedApril 19, 2019
June 1, 2017
1 year
October 5, 2015
April 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of subjects with a response for Early Clinical Response
Proportion of subjects with a response for Early Clinical Response (ECR), defined as alive and achieved ≥ 20% reduction from baseline in the lesion size at 48-72 hours after start of study drug, without receipt of additional non-study antibiotic therapy.
48 to 72 hours after starting treatment
Secondary Outcomes (2)
Proportion of subjects with clinical success at Post-treatment Evaluation
7 to 14 days after end of treatment
Incidence of adverse events [Safety and tolerability], Clinical Laboratory Evaluations
Up to 24 months
Study Arms (2)
CEM-102 (Sodium fusidate)
EXPERIMENTAL1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy (10 days total)
Linezolid
ACTIVE COMPARATOR600 mg by mouth every 12 hours for 10 days
Interventions
Eligibility Criteria
You may qualify if:
- Adolescents between 12 to 18 years old must weigh \>60 kg
- Patients diagnosed with ABSSSI with at least one systemic sign of infection
- Diagnosed with cellulitis, major cutaneous abscess, or wound infections (traumatic or surgical)
- Surface redness, edema or induration must be of a minimum surface area of 75 cm2, or extending ≥5 cm from the peripheral margin of the abscess
- Suspected or documented ABSSSI caused by a Gram-positive pathogen
You may not qualify if:
- Involving a chronic diabetic foot infection (diabetic foot ulcer)
- Involving burns
- Involving an anatomical location (e.g. perirectal area) where the incidence of Gram-negative and/or anaerobic pathogen involvement is likely
- Documented bacteremia associated with the current ABSSSI
- Known severe renal impairment, as indicated by estimated CrCl \<30 mL/min (by Cockcroft-Gault calculation)
- Evidence of significant liver disease: ALT \>3x ULN, or direct bilirubin \>ULN; known cirrhosis with decompensation (i.e. Child-Pugh Class B or C disease)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arrevus Inc.lead
Study Sites (62)
Unknown Facility
Anaheim, California, 92804, United States
Unknown Facility
Bakersfield, California, 93301, United States
Unknown Facility
Buena Park, California, 90620, United States
Unknown Facility
Fountain Valley, California, 92708, United States
Unknown Facility
La Mesa, California, 91942, United States
Unknown Facility
La Palma, California, 90623, United States
Unknown Facility
Long Beach, California, 90813, United States
Unknown Facility
Los Angeles, California, 90020, United States
Unknown Facility
Modesto, California, 95350, United States
Unknown Facility
National City, California, 91950, United States
Unknown Facility
Oceanside, California, 92056, United States
Unknown Facility
Riverside, California, 92506, United States
Unknown Facility
San Diego, California, 89109, United States
Unknown Facility
San Diego, California, 91911, United States
Unknown Facility
San Diego, California, 91942, United States
Unknown Facility
San Diego, California, 92114, United States
Unknown Facility
San Diego, California, 92120, United States
Unknown Facility
San Dimas, California, 91773, United States
Unknown Facility
Stockton, California, 95204, United States
Unknown Facility
Sylmar, California, 91342, United States
Unknown Facility
DeBary, Florida, 32713, United States
Unknown Facility
DeLand, Florida, 32720, United States
Unknown Facility
Doral, Florida, 33126, United States
Unknown Facility
Doral, Florida, 33166, United States
Unknown Facility
Hollywood, Florida, 33021, United States
Unknown Facility
Miami, Florida, 33015, United States
Unknown Facility
Miami, Florida, 33126, United States
Unknown Facility
Miami, Florida, 33144, United States
Unknown Facility
Miami, Florida, 33155, United States
Unknown Facility
Miami, Florida, 33175, United States
Unknown Facility
Miami Lakes, Florida, 33014, United States
Unknown Facility
Orlando, Florida, 32806, United States
Unknown Facility
South Miami, Florida, 33143, United States
Unknown Facility
West Palm Beach, Florida, 33401, United States
Unknown Facility
Augusta, Georgia, 30909, United States
Unknown Facility
Columbus, Georgia, 31904, United States
Unknown Facility
Savannah, Georgia, 31401, United States
Unknown Facility
Baker, Louisiana, 70714, United States
Unknown Facility
Eunice, Louisiana, 70535, United States
Unknown Facility
Lutherville, Maryland, 21093, United States
Unknown Facility
Boston, Massachusetts, 02111, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Royal Oak, Michigan, 48703, United States
Unknown Facility
St Louis, Missouri, 63128, United States
Unknown Facility
Butte, Montana, 59701, United States
Unknown Facility
Lincoln, Nebraska, 68510, United States
Unknown Facility
Somers Point, New Jersey, 08244, United States
Unknown Facility
Teaneck, New Jersey, 07666, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Philadelphia, Pennsylvania, 19103, United States
Unknown Facility
Lancaster, South Carolina, 29720, United States
Unknown Facility
Summerville, South Carolina, 29485, United States
Unknown Facility
Rapid City, South Dakota, 57702, United States
Unknown Facility
Jackson, Tennessee, 38305, United States
Unknown Facility
Gonzales, Texas, 78629, United States
Unknown Facility
Houston, Texas, 77011, United States
Unknown Facility
Houston, Texas, 77084, United States
Unknown Facility
Houston, Texas, 77093, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Splendora, Texas, 77372, United States
Unknown Facility
San Juan, 00909-3004, Puerto Rico
Unknown Facility
San Juan, 00909, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Richard Pushkin, MD
Melinta Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- 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
October 5, 2015
First Posted
October 7, 2015
Study Start
November 1, 2015
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
April 19, 2019
Record last verified: 2017-06