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

April 15, 2019 updated by: Arrevus Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
716

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects with a response for Early Clinical Response
Time Frame: 48 to 72 hours after starting treatment
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects with clinical success at Post-treatment Evaluation
Time Frame: 7 to 14 days after end of treatment
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
Time Frame: Up to 24 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arrevus Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Richard Pushkin, MD, Melinta Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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