Skin Diseases, Bacterial, Gram-Positive Bacterial Infections
Conditions
Keywords
ABSSSI, Acute bacterial skin and skin structure infection
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
Interventions
IV and oral contezolid acefosamil given twice a day for 10 to 14 days
DRUGlinezolid 600 mg
IV and oral linezolid given twice a day for 10 to 14 days
Sponsors
MicuRx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early Clinical Response at the Early Assessment Visit (ITT Population) | 48 to 72 hours after the start of study drug | 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. |
Countries
United States
Participant flow
Recruitment details
196 subjects were randomized
Participants by arm
| Arm | Count |
|---|---|
| Contezolid Acefosamil Contezolid acefosamil 1500 IV x 1 dose, followed by 1000 mg IV q12h, for at least 3 total IV doses, followed by 1300 mg PO q12h | 131 |
| Linezolid Linezolid 600 mg IV q12h, for at least 3 total IV doses, followed by 600 mg PO q12h | 65 |
| Total | 196 |
Baseline characteristics
| Characteristic | Total | Contezolid Acefosamil | Linezolid |
|---|---|---|---|
| Age, Continuous | 44.5 years STANDARD_DEVIATION 11.57 | 44.9 years STANDARD_DEVIATION 11.87 | 43.7 years STANDARD_DEVIATION 10.94 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 79 Participants | 51 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 117 Participants | 80 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 6 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 12 Participants | 8 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 5 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 167 Participants | 109 Participants | 58 Participants |
| Sex: Female, Male Female | 70 Participants | 52 Participants | 18 Participants |
| Sex: Female, Male Male | 126 Participants | 79 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 123 | 1 / 64 |
| other Total, other adverse events | 55 / 123 | 27 / 64 |
| serious Total, serious adverse events | 3 / 123 | 1 / 64 |
Outcome results
Primary
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.
Time frame: 48 to 72 hours after the start of study drug
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Contezolid Acefosamil | Early Clinical Response at the Early Assessment Visit (ITT Population) | Responder | 102 Participants |
| Contezolid Acefosamil | Early Clinical Response at the Early Assessment Visit (ITT Population) | Non-Responder | 3 Participants |
| Contezolid Acefosamil | Early Clinical Response at the Early Assessment Visit (ITT Population) | Indeterminate | 26 Participants |
| Linezolid | Early Clinical Response at the Early Assessment Visit (ITT Population) | Responder | 51 Participants |
| Linezolid | Early Clinical Response at the Early Assessment Visit (ITT Population) | Non-Responder | 6 Participants |
| Linezolid | Early Clinical Response at the Early Assessment Visit (ITT Population) | Indeterminate | 8 Participants |
95% CI: [-14, 2.8]