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

NCT ID: NCT02269319

Last Updated: 2024-11-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bacterial Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MRX-I

MRX-I tablets 800 mg given twice a day for 10 days

Group Type EXPERIMENTAL

MRX-I

Intervention Type DRUG

Oral MRX-I 800mg given twice a day for 10 days

Linezolid

Linezolid 600 mg given twice a day for 10 days

Group Type ACTIVE_COMPARATOR

Linezolid

Intervention Type DRUG

Oral linezolid 600mg given twice a day for 10 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MRX-I

Oral MRX-I 800mg given twice a day for 10 days

Intervention Type DRUG

Linezolid

Oral linezolid 600mg given twice a day for 10 days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zyvox

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

MicuRx

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MRX-I-03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.