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Oral Sodium Fusidate (CEM-102...

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

Last Updated: 2019-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

716 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-11-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Acute Bacterial Skin and Skin Structure Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

sodium fusidate

Intervention Type DRUG

Linezolid

600 mg by mouth every 12 hours for 10 days

Group Type ACTIVE_COMPARATOR

linezolid

Intervention Type DRUG

Interventions

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sodium fusidate

Intervention Type DRUG

linezolid

Intervention Type DRUG

Other Intervention Names

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CEM-102

Eligibility Criteria

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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)

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Pushkin, MD

Role: STUDY_DIRECTOR

Melinta Therapeutics, Inc.

Locations

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Anaheim, California, United States

Site Status

Bakersfield, California, United States

Site Status

Buena Park, California, United States

Site Status

Fountain Valley, California, United States

Site Status

La Mesa, California, United States

Site Status

La Palma, California, United States

Site Status

Long Beach, California, United States

Site Status

Los Angeles, California, United States

Site Status

Modesto, California, United States

Site Status

National City, California, United States

Site Status

Oceanside, California, United States

Site Status

Riverside, California, United States

Site Status