Phase 2
N=120
MRX-I Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
Bacterial Infections
Bottom Line
View on ClinicalTrials.gov: NCT02269319 ↗Enrolled (actual)
120
Serious AEs
0.8%
Results posted
Nov 2024
Primary outcome: Primary: Number of Patients at the Early Assessment Visit With a 20% Reduction in ABSSSI Lesion Size Compared to Baseline — 72; 35 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MRX-I (Drug); Linezolid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MicuRx
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients at the Early Assessment Visit With a 20% Reduction in ABSSSI Lesion Size Compared to Baseline |
72; 35 | — |
| SECONDARY Number of Patients at EOT With a 80% Reduction in ABSSSI Lesion Size Compared to Baseline |
70; 32 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT02269319). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.