Back to resultsContezolid Acefosamil Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
Primary Purpose
Skin Diseases, Bacterial, Gram-Positive Bacterial Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
contezolid acefosamil
linezolid 600 mg
Sponsored by
About this trial
This is an interventional treatment trial for Skin Diseases, Bacterial focused on measuring ABSSSI, Acute bacterial skin and skin structure infection
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
Sites / Locations
- MicuRx Site #106
- MicuRx Site #103
- MicuRx Site #102
- MicuRx Site #104
- MicuRx Site #107
- MicuRx Site #105
- MicuRx Site #108
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
contezolid acefosamil
linezolid
Arm Description
contezolid 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 600 mg IV q12h for at least 3 total IV doses, followed by 600 mg PO q12h for 10 to 14 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03747497
Brief Title
Contezolid Acefosamil Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
March 26, 2019 (Actual)
Study Completion Date
March 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MicuRx
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases, Bacterial, Gram-Positive Bacterial Infections
Keywords
ABSSSI, Acute bacterial skin and skin structure infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
196 (Actual)
8. Arms, Groups, and Interventions
Arm Title
contezolid acefosamil
Arm Type
Experimental
Arm Description
contezolid 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
Arm Title
linezolid
Arm Type
Active Comparator
Arm Description
linezolid 600 mg IV q12h for at least 3 total IV doses, followed by 600 mg PO q12h for 10 to 14 days
Intervention Type
Drug
Intervention Name(s)
contezolid acefosamil
Intervention Description
IV and oral contezolid acefosamil given twice a day for 10 to 14 days
Intervention Type
Drug
Intervention Name(s)
linezolid 600 mg
Other Intervention Name(s)
Zyvox
Intervention Description
IV and oral linezolid given twice a day for 10 to 14 days
Primary Outcome Measure Information:
Title
Early Clinical Response at the Early Assessment Visit (ITT Population)
Description
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.
Time Frame
48 to 72 hours after the start of study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
MicuRx Site #106
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
MicuRx Site #103
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
MicuRx Site #102
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
MicuRx Site #104
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
MicuRx Site #107
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
MicuRx Site #105
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
MicuRx Site #108
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Contezolid Acefosamil Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
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