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MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

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ClinicalTrials.gov Identifier: NCT02269319
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
MicuRx

Brief Summary:
The purpose of this study is to determine whether MRX-I is as safe and effective as Linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections

Condition or disease Intervention/treatment Phase
Bacterial Infections Drug: MRX-I Drug: Linezolid Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of MRX-I Versus Linezolid in Adult Subjects With Acute Bacterial Skin and Skin Structure Infection
Study Start Date : February 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Linezolid

Arm Intervention/treatment
Experimental: MRX-I
MRX-I tablets 800 mg given twice a day for 10 days
Drug: MRX-I
Oral MRX-I 800mg given twice a day for 10 days

Active Comparator: Linezolid
Linezolid 600 mg given twice a day for 10 days
Drug: Linezolid
Oral linezolid 600mg given twice a day for 10 days
Other Name: Zyvox




Primary Outcome Measures :
  1. Number of patients at the early assessment visit with a 20% reduction in ABSSSI lesion size compared to baseline [ Time Frame: 48-72 hours ]
    • Did not receive a systemic antibacterial agent with activity against gram-positive organisms
    • Did not die of any cause up to EA

  2. Number of patients with adverse events as a measure of safety and tolerability [ Time Frame: Screening though Day 28 ]
    Changes in vital signs, ECG parameters and laboratory data


Secondary Outcome Measures :
  1. Number of MITT patients at the early assessment visit with a 20% reduction in ABSSSI lesion size compared to baseline [ Time Frame: 48-72 hours ]
  2. Number of patients at EOT with a 80% reduction in ABSSSI lesion size compared to baseline [ Time Frame: Day 10 ]
  3. Number of patients with resolution or near resolution of most baseline ABSSSI symptoms and signs absence or near absence of systemic signs of infection at Post Trial Assessment [ Time Frame: 7-14 days after the End of Therapy ]
  4. Number of patients with a microbiological outcome of eradication or presumed eradication at Post Trial Assessment [ Time Frame: 7-14 days after the End of Therapy ]
  5. Population PK of MRX-I Tablets [ Time Frame: Day 3 and Day 7 ]
    • Influence of baseline subject characteristics on blood levels of MRX-I



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (ABSSSI)
  • Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections

Exclusion Criteria:

  • Uncomplicated skin infections
  • Severe sepsis or septic shock
  • ABSSSI solely due to gram-negative pathogens
  • Prior systemic antibiotics within 96 hours of randomization

Responsible Party: MicuRx
ClinicalTrials.gov Identifier: NCT02269319     History of Changes
Other Study ID Numbers: MRX-I-03
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017

Keywords provided by MicuRx:
ABSSSI
MRX-I
Acute Bacterial Skin and Skin Structure Infections

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