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

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

Study Overview

• Status: Completed
• Conditions: Acute Bacterial Skin and Skin Structure Infections
• Intervention / Treatment: Drug: sodium fusidate; Drug: linezolid

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

• Study Type: Interventional
• Enrollment (Actual): 716
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00909
  • San Juan, Puerto Rico, 00909-3004
• United States
  • California
    • Anaheim, California, United States, 92804
    • Bakersfield, California, United States, 93301
    • Buena Park, California, United States, 90620
    • Fountain Valley, California, United States, 92708
    • La Mesa, California, United States, 91942
    • La Palma, California, United States, 90623
    • Long Beach, California, United States, 90813
    • Los Angeles, California, United States, 90020
    • Modesto, California, United States, 95350
    • National City, California, United States, 91950
    • Oceanside, California, United States, 92056
    • Riverside, California, United States, 92506
    • San Diego, California, United States, 92120
    • San Diego, California, United States, 92114
    • San Diego, California, United States, 89109
    • San Diego, California, United States, 91911
    • San Diego, California, United States, 91942
    • San Dimas, California, United States, 91773
    • Stockton, California, United States, 95204
    • Sylmar, California, United States, 91342
  • Florida
    • DeBary, Florida, United States, 32713
    • DeLand, Florida, United States, 32720
    • Doral, Florida, United States, 33166
    • Doral, Florida, United States, 33126
    • Hollywood, Florida, United States, 33021
    • Miami, Florida, United States, 33126
    • Miami, Florida, United States, 33144
    • Miami, Florida, United States, 33155
    • Miami, Florida, United States, 33175
    • Miami, Florida, United States, 33015
    • Miami Lakes, Florida, United States, 33014
    • Orlando, Florida, United States, 32806
    • South Miami, Florida, United States, 33143
    • West Palm Beach, Florida, United States, 33401
  • Georgia
    • Augusta, Georgia, United States, 30909
    • Columbus, Georgia, United States, 31904
    • Savannah, Georgia, United States, 31401
  • Louisiana
    • Baker, Louisiana, United States, 70714
    • Eunice, Louisiana, United States, 70535
  • Maryland
    • Lutherville, Maryland, United States, 21093
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
  • Michigan
    • Detroit, Michigan, United States, 48202
    • Royal Oak, Michigan, United States, 48703
  • Missouri
    • Saint Louis, Missouri, United States, 63128
  • Montana
    • Butte, Montana, United States, 59701
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
  • New Jersey
    • Somers Point, New Jersey, United States, 08244
    • Teaneck, New Jersey, United States, 07666
  • Ohio
    • Cincinnati, Ohio, United States, 45219
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
  • South Carolina
    • Lancaster, South Carolina, United States, 29720
    • Summerville, South Carolina, United States, 29485
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
  • Tennessee
    • Jackson, Tennessee, United States, 38305
  • Texas
    • Gonzales, Texas, United States, 78629
    • Houston, Texas, United States, 77011
    • Houston, Texas, United States, 77093
    • Houston, Texas, United States, 77084
    • San Antonio, Texas, United States, 78229
    • Splendora, Texas, United States, 77372

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CEM-102 (Sodium fusidate); 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)	Drug: sodium fusidate; Other Names: CEM-102
ACTIVE_COMPARATOR: Linezolid; 600 mg by mouth every 12 hours for 10 days	Drug: linezolid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 to 14 days after end of treatment
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	Up to 24 months

Collaborators and Investigators

• Sponsor: Arrevus Inc.
• Investigators: Study Director: Richard Pushkin, MD, Melinta Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ACTUAL): November 1, 2016
• Study Completion (ACTUAL): November 1, 2016

Study Registration Dates

• First Submitted: October 5, 2015
• First Submitted That Met QC Criteria: October 6, 2015
• First Posted (ESTIMATE): October 7, 2015

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: skin infection; fusidic acid
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Infections; Communicable Diseases; Skin Diseases, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Linezolid; Fusidic Acid
• Other Study ID Numbers: CE06-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No