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

Bacterial Infections Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02269319
• Other study ID #: MRX-I-03
• Status: Completed
• Phase: Phase 2
• Start date: February 2015
• Est. completion date: September 2015

Study information

• Verified date: January 2017
• Source: MicuRx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infections
• Skin Diseases, Bacterial

Intervention

Drug:
• MRX-I
Oral MRX-I 800mg given twice a day for 10 days
• Linezolid
Oral linezolid 600mg given twice a day for 10 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MicuRx

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of patients with adverse events as a measure of safety and tolerability	Changes in vital signs, ECG parameters and laboratory data	Screening though Day 28
Secondary	Number of MITT patients at the early assessment visit with a 20% reduction in ABSSSI lesion size compared to baseline		48-72 hours
Secondary	Number of patients at EOT with a 80% reduction in ABSSSI lesion size compared to baseline		Day 10
Secondary	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		7-14 days after the End of Therapy
Secondary	Number of patients with a microbiological outcome of eradication or presumed eradication at Post Trial Assessment		7-14 days after the End of Therapy
Secondary	Population PK of MRX-I Tablets	• Influence of baseline subject characteristics on blood levels of MRX-I	Day 3 and Day 7