Contezolid Acefosamil Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
A Phase 2, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Contezolid Acefosamil Compared to Linezolid Administered Intravenously and Orally to Adult Subjects With Acute Bacterial Skin and Skin Structure Infection
1 other identifier
interventional
196
1 country
7
Brief Summary
The purpose of this study is to determine whether contezolid acefosamil 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 P75+ for phase_2
Started Nov 2018
Shorter than P25 for phase_2
7 active sites
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
November 12, 2018
CompletedStudy Start
First participant enrolled
November 15, 2018
CompletedFirst Posted
Study publicly available on registry
November 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2019
CompletedResults Posted
Study results publicly available
April 30, 2021
CompletedNovember 8, 2022
October 1, 2022
4 months
November 12, 2018
April 6, 2021
October 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Early Clinical Response at the Early Assessment Visit (ITT Population)
Early clinical response assessment based on the electronic case report form (eCRF) data at Early Assessment (48-72 hours after start of study drug) where a successful response (i.e., "responder") was defined as a reduction in primary ABSSSI lesion size ≥20% compared to baseline, and the subject did not receive a non-protocol specified systemic antibacterial agent with activity against Gram-positive organisms for the treatment of ABSSSI and did not die of any cause up to Early Assessment.
48 to 72 hours after the start of study drug
Study Arms (2)
contezolid acefosamil
EXPERIMENTALcontezolid acefosamil 1500 mg IV x 1 dose, followed by 1000 mg IV q12h for at least 3 total IV doses, followed by 1300 mg PO q12h for 10 to 14 days
linezolid
ACTIVE COMPARATORlinezolid 600 mg IV q12h for at least 3 total IV doses, followed by 600 mg PO q12h for 10 to 14 days
Interventions
IV and oral contezolid acefosamil given twice a day for 10 to 14 days
IV and oral linezolid given twice a day for 10 to 14 days
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
Study Sites (7)
MicuRx Site #106
Chula Vista, California, 91911, United States
MicuRx Site #103
La Mesa, California, 91942, United States
MicuRx Site #102
Long Beach, California, 90806, United States
MicuRx Site #104
Stockton, California, 95204, United States
MicuRx Site #107
Butte, Montana, 59701, United States
MicuRx Site #105
Las Vegas, Nevada, 89106, United States
MicuRx Site #108
Las Vegas, Nevada, 89109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- 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
November 12, 2018
First Posted
November 20, 2018
Study Start
November 15, 2018
Primary Completion
March 26, 2019
Study Completion
March 26, 2019
Last Updated
November 8, 2022
Results First Posted
April 30, 2021
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share