MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
ABSSSI
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
1 other identifier
interventional
120
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2015
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2014
CompletedFirst Posted
Study publicly available on registry
October 21, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
November 4, 2024
CompletedNovember 4, 2024
January 1, 2017
6 months
October 11, 2014
October 30, 2023
October 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
48-72 hours
Secondary Outcomes (1)
Number of Patients at EOT With a 80% Reduction in ABSSSI Lesion Size Compared to Baseline
Day 10
Study Arms (2)
MRX-I
EXPERIMENTALMRX-I tablets 800 mg given twice a day for 10 days
Linezolid
ACTIVE COMPARATORLinezolid 600 mg given twice a day for 10 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Uncomplicated skin infections
- Severe sepsis or septic shock
- ABSSSI solely due to gram-negative pathogens
- Prior systemic antibiotics within 96 hours of randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MicuRxlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Proof of concept study was limited in size and scope. Given the number of male to female subjects, the interpretation of the results were limited. Since the duration of therapy was up to 10 days, assessment of long-term safety risks was limited.
Results Point of Contact
- Title
- John M. Sall, Global Head of Regulatory
- Organization
- MicuRx Pharmaceuticals Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2014
First Posted
October 21, 2014
Study Start
February 1, 2015
Primary Completion
August 1, 2015
Study Completion
September 1, 2015
Last Updated
November 4, 2024
Results First Posted
November 4, 2024
Record last verified: 2017-01