Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Acute Bacterial Skin and Skin Structure Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02570490
• Other study ID #: CE06-301
• Status: Completed
• Phase: Phase 3
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: June 2017
• Source: Arrevus Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 716
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Bacterial Skin and Skin Structure Infections
• Communicable Diseases
• Infection
• Skin Diseases, Bacterial

Intervention

Drug:
• sodium fusidate

• linezolid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Arrevus Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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