Clinical trial NCT02570490: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Bacterial Skin and Skin Structure Infections
Keywords: fusidic acid
skin infection
Lead sponsor: Arrevus Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-07
Enrollment: 716
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Proportion of subjects with a response for Early Clinical Response
timeFrame: 48 to 72 hours after starting treatment
Secondary outcomes:
measure: Proportion of subjects with clinical success at Post-treatment Evaluation
timeFrame: 7 to 14 days after end of treatment
measure: Incidence of adverse events [Safety and tolerability], Clinical Laboratory Evaluations
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: Bakersfield
country: United States
state: California
city: Buena Park
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: La Mesa
country: United States
state: California
city: La Palma
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Modesto
country: United States
state: California
city: National City
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Dimas
country: United States
state: California
city: Stockton
country: United States
state: California
city: Sylmar
country: United States
state: California
city: DeBary
country: United States
state: Florida
city: DeLand
country: United States
state: Florida
city: Doral
country: United States
state: Florida
city: Doral
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Miami Lakes
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Columbus
country: United States
state: Georgia
city: Savannah
country: United States
state: Georgia
city: Baker
country: United States
state: Louisiana
city: Eunice
country: United States
state: Louisiana
city: Lutherville
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Royal Oak
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Butte
country: United States
state: Montana
city: Lincoln
country: United States
state: Nebraska
city: Somers Point
country: United States
state: New Jersey
city: Teaneck
country: United States
state: New Jersey
city: Cincinnati
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: South Carolina
city: Summerville
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: Jackson
country: United States
state: Tennessee
city: Gonzales
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Splendora
country: United States
state: Texas
city: San Juan
country: Puerto Rico
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Melinta Therapeutics, Inc.
name: Richard Pushkin, MD
role: STUDY_DIRECTOR
References: