Back to resultsMRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Primary Purpose
Bacterial Infections
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MRX-I
Linezolid
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Infections focused on measuring ABSSSI, MRX-I, Acute Bacterial Skin and Skin Structure Infections
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MRX-I
Linezolid
Arm Description
MRX-I tablets 800 mg given twice a day for 10 days
Linezolid 600 mg given twice a day for 10 days
Outcomes
Primary Outcome Measures
Number of patients at the early assessment visit with a 20% reduction in ABSSSI lesion size compared to baseline
Did not receive a systemic antibacterial agent with activity against gram-positive organisms
Did not die of any cause up to EA
Number of patients with adverse events as a measure of safety and tolerability
Changes in vital signs, ECG parameters and laboratory data
Secondary Outcome Measures
Number of MITT patients at the early assessment visit with a 20% reduction in ABSSSI lesion size compared to baseline
Number of patients at EOT with a 80% reduction in ABSSSI lesion size compared to baseline
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
Number of patients with a microbiological outcome of eradication or presumed eradication at Post Trial Assessment
Population PK of MRX-I Tablets
• Influence of baseline subject characteristics on blood levels of MRX-I
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02269319
Brief Title
MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
Acronym
ABSSSI
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 Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MicuRx
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections
Keywords
ABSSSI, MRX-I, Acute Bacterial Skin and Skin Structure Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRX-I
Arm Type
Experimental
Arm Description
MRX-I tablets 800 mg given twice a day for 10 days
Arm Title
Linezolid
Arm Type
Active Comparator
Arm Description
Linezolid 600 mg given twice a day for 10 days
Intervention Type
Drug
Intervention Name(s)
MRX-I
Intervention Description
Oral MRX-I 800mg given twice a day for 10 days
Intervention Type
Drug
Intervention Name(s)
Linezolid
Other Intervention Name(s)
Zyvox
Intervention Description
Oral linezolid 600mg given twice a day for 10 days
Primary Outcome Measure Information:
Title
Number of patients at the early assessment visit with a 20% reduction in ABSSSI lesion size compared to baseline
Description
Did not receive a systemic antibacterial agent with activity against gram-positive organisms
Did not die of any cause up to EA
Time Frame
48-72 hours
Title
Number of patients with adverse events as a measure of safety and tolerability
Description
Changes in vital signs, ECG parameters and laboratory data
Time Frame
Screening though Day 28
Secondary Outcome Measure Information:
Title
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
Title
Number of patients at EOT with a 80% reduction in ABSSSI lesion size compared to baseline
Time Frame
Day 10
Title
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
Title
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
Title
Population PK of MRX-I Tablets
Description
• Influence of baseline subject characteristics on blood levels of MRX-I
Time Frame
Day 3 and Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
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