Back to resultsOral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Primary Purpose
Acute Bacterial Skin and Skin Structure Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
sodium fusidate
linezolid
Sponsored by
About this trial
This is an interventional treatment trial for Acute Bacterial Skin and Skin Structure Infections focused on measuring fusidic acid, skin infection
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CEM-102 (Sodium fusidate)
Linezolid
Arm Description
1500 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)
600 mg by mouth every 12 hours for 10 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Proportion of subjects with clinical success at Post-treatment Evaluation
Proportion of subjects with clinical success at PTE, in the ITT and clinically evaluable (CE) analysis sets.
Incidence of adverse events [Safety and tolerability], Clinical Laboratory Evaluations
Incidence of adverse events, vital sign changes, physical exam changes, and clinical laboratory evaluations will be presented by study arm
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02570490
Brief Title
Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arrevus Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
The primary objective is to demonstrate the non-inferiority of oral CEM-102 (loading dose regimen of 1500 mg every 12 hours for 2 doses, followed by 600 mg every 12 hours thereafter) compared to oral linezolid (600 mg every 12 hours), each administered for 10 days, for Early Clinical Response (ECR) in the intent to treat (ITT) analysis set in subjects with acute bacterial skin and skin structure infections (ABSSSI). Subjects with an ABSSSI caused by suspected or documented Gram-positive pathogen(s) at baseline will be randomized 1:1 to study treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bacterial Skin and Skin Structure Infections
Keywords
fusidic acid, skin infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
716 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CEM-102 (Sodium fusidate)
Arm Type
Experimental
Arm Description
1500 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)
Arm Title
Linezolid
Arm Type
Active Comparator
Arm Description
600 mg by mouth every 12 hours for 10 days
Intervention Type
Drug
Intervention Name(s)
sodium fusidate
Other Intervention Name(s)
CEM-102
Intervention Type
Drug
Intervention Name(s)
linezolid
Primary Outcome Measure Information:
Title
Proportion of subjects with a response for Early Clinical Response
Description
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.
Time Frame
48 to 72 hours after starting treatment
Secondary Outcome Measure Information:
Title
Proportion of subjects with clinical success at Post-treatment Evaluation
Description
Proportion of subjects with clinical success at PTE, in the ITT and clinically evaluable (CE) analysis sets.
Time Frame
7 to 14 days after end of treatment
Title
Incidence of adverse events [Safety and tolerability], Clinical Laboratory Evaluations
Description
Incidence of adverse events, vital sign changes, physical exam changes, and clinical laboratory evaluations will be presented by study arm
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Pushkin, MD
Organizational Affiliation
Melinta Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
City
La Palma
State/Province
California
ZIP/Postal Code
90623
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90020
Country
United States
City
Modesto
State/Province
California
ZIP/Postal Code
95350
Country
United States
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
89109
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
91911
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
91942
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
City
Doral
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31401
Country
United States
City
Baker
State/Province
Louisiana
ZIP/Postal Code
70714
Country
United States
City
Eunice
State/Province
Louisiana
ZIP/Postal Code
70535
Country
United States
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48703
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
City
Lancaster
State/Province
South Carolina
ZIP/Postal Code
29720
Country
United States
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
City
Gonzales
State/Province
Texas
ZIP/Postal Code
78629
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77011
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77093
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Splendora
State/Province
Texas
ZIP/Postal Code
77372
Country
United States
City
San Juan
ZIP/Postal Code
00909-3004
Country
Puerto Rico
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
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