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

Sponsor
Arrevus Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02570490
Collaborator
(none)
716
Enrollment
62
Locations
2
Arms
12
Duration (Months)
11.5
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
716 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Nov 1, 2016

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of subjects with a response for Early Clinical Response [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.

    Secondary Outcome Measures

    1. Proportion of subjects with clinical success at Post-treatment Evaluation [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.

    2. Incidence of adverse events [Safety and tolerability], Clinical Laboratory Evaluations [Up to 24 months]

      Incidence of adverse events, vital sign changes, physical exam changes, and clinical laboratory evaluations will be presented by study arm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anaheim California United States 92804
    2 Bakersfield California United States 93301
    3 Buena Park California United States 90620
    4 Fountain Valley California United States 92708
    5 La Mesa California United States 91942
    6 La Palma California United States 90623
    7 Long Beach California United States 90813
    8 Los Angeles California United States 90020
    9 Modesto California United States 95350
    10 National City California United States 91950
    11 Oceanside California United States 92056
    12 Riverside California United States 92506
    13 San Diego California United States 89109
    14 San Diego California United States 91911
    15 San Diego California United States 91942
    16 San Diego California United States 92114
    17 San Diego California United States 92120
    18 San Dimas California United States 91773
    19 Stockton California United States 95204
    20 Sylmar California United States 91342
    21 DeBary Florida United States 32713
    22 DeLand Florida United States 32720
    23 Doral Florida United States 33126
    24 Doral Florida United States 33166
    25 Hollywood Florida United States 33021
    26 Miami Lakes Florida United States 33014
    27 Miami Florida United States 33015
    28 Miami Florida United States 33126
    29 Miami Florida United States 33144
    30 Miami Florida United States 33155
    31 Miami Florida United States 33175
    32 Orlando Florida United States 32806
    33 South Miami Florida United States 33143
    34 West Palm Beach Florida United States 33401
    35 Augusta Georgia United States 30909
    36 Columbus Georgia United States 31904
    37 Savannah Georgia United States 31401
    38 Baker Louisiana United States 70714
    39 Eunice Louisiana United States 70535
    40 Lutherville Maryland United States 21093
    41 Boston Massachusetts United States 02111
    42 Detroit Michigan United States 48202
    43 Royal Oak Michigan United States 48703
    44 Saint Louis Missouri United States 63128
    45 Butte Montana United States 59701
    46 Lincoln Nebraska United States 68510
    47 Somers Point New Jersey United States 08244
    48 Teaneck New Jersey United States 07666
    49 Cincinnati Ohio United States 45219
    50 Philadelphia Pennsylvania United States 19103
    51 Lancaster South Carolina United States 29720
    52 Summerville South Carolina United States 29485
    53 Rapid City South Dakota United States 57702
    54 Jackson Tennessee United States 38305
    55 Gonzales Texas United States 78629
    56 Houston Texas United States 77011
    57 Houston Texas United States 77084
    58 Houston Texas United States 77093
    59 San Antonio Texas United States 78229
    60 Splendora Texas United States 77372
    61 San Juan Puerto Rico 00909-3004
    62 San Juan Puerto Rico 00909

    Sponsors and Collaborators

    • Arrevus Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arrevus Inc.
    ClinicalTrials.gov Identifier:
    NCT02570490
    Other Study ID Numbers:
    • CE06-301
    First Posted:
    Oct 7, 2015
    Last Update Posted:
    Apr 19, 2019
    Last Verified:
    Jun 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Arrevus Inc.
    fusidic acid
    skin infection
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Skin Diseases, Bacterial
    Linezolid
    Fusidic Acid

    Study Results

    No Results Posted as of Apr 19, 2019