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

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ClinicalTrials.gov Identifier: NCT02570490
Recruitment Status : Completed
First Posted : October 7, 2015
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Cempra Inc

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
Acute Bacterial Skin and Skin Structure Infections Drug: sodium fusidate Drug: linezolid 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 Type : Interventional  (Clinical Trial)
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 : November 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Linezolid
U.S. FDA Resources

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 Name: CEM-102
Active Comparator: Linezolid
600 mg by mouth every 12 hours for 10 days
Drug: linezolid



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570490


  Show 62 Study Locations
Sponsors and Collaborators
Cempra Inc
Investigators
Study Director: Richard Pushkin, MD Cempra Inc

Responsible Party: Cempra Inc
ClinicalTrials.gov Identifier: NCT02570490     History of Changes
Other Study ID Numbers: CE06-301
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cempra Inc:
fusidic acid
skin infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Linezolid
Fusidic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action