Overview

This trial is active, not recruiting.

Condition bacterial infections
Treatments mrx-i, linezolid
Phase phase 2
Sponsor MicuRx
Start date January 2015
End date October 2015
Trial size 120 participants
Trial identifier NCT02269319, MRX-I-03

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
MRX-I tablets 800 mg given twice a day for 10 days
mrx-i
Oral MRX-I 800mg given twice a day for 10 days
(Active Comparator)
Linezolid 600 mg given twice a day for 10 days
linezolid Zyvox
Oral linezolid 600mg given twice a day for 10 days

Primary Outcomes

Measure
Number of patients at the early assessment visit with a 20% reduction in ABSSSI lesion size compared to baseline
time frame: 48-72 hours
Number of patients with adverse events as a measure of safety and tolerability
time frame: Screening though Day 28

Secondary Outcomes

Measure
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
Number of patients at EOT with a 80% reduction in ABSSSI lesion size compared to baseline
time frame: Day 10
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
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
Population PK of MRX-I Tablets
time frame: Day 3 and Day 7

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by MicuRx.