Bacterial Infections
Conditions
Keywords
ABSSSI, MRX-I, Acute Bacterial Skin and Skin Structure Infections
Brief 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
Interventions
DRUGMRX-I
Oral MRX-I 800mg given twice a day for 10 days
DRUGLinezolid
Oral linezolid 600mg given twice a day for 10 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 |
|---|---|---|
| Number of Patients at the Early Assessment Visit With a 20% Reduction in ABSSSI Lesion Size Compared to Baseline | 48-72 hours | * Did not receive a systemic antibacterial agent with activity against gram-positive organisms * Did not die of any cause up to EA |
Secondary
| Measure | Time frame |
|---|---|
| Number of Patients at EOT With a 80% Reduction in ABSSSI Lesion Size Compared to Baseline | Day 10 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MRX-I MRX-I tablets 800 mg given twice a day for 10 days
MRX-I: Oral MRX-I 800mg given twice a day for 10 days | 80 |
| Linezolid Linezolid 600 mg given twice a day for 10 days
Linezolid: Oral linezolid 600mg given twice a day for 10 days | 40 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Instructions not followed | 1 | 0 |
| Overall Study | Lost to Follow-up | 4 | 3 |
Baseline characteristics
| Characteristic | MRX-I | Linezolid | Total |
|---|---|---|---|
| Age, Continuous | 37.9 years | 38.8 years | 38.2 years |
| Sex: Female, Male Female | 27 Participants | 13 Participants | 40 Participants |
| Sex: Female, Male Male | 53 Participants | 27 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 40 |
| other Total, other adverse events | 47 / 80 | 12 / 40 |
| serious Total, serious adverse events | 1 / 80 | 0 / 40 |
Outcome results
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
Time frame: 48-72 hours
Population: Intent-to-Treat (ITT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MRX-I | Number of Patients at the Early Assessment Visit With a 20% Reduction in ABSSSI Lesion Size Compared to Baseline | 72 Participants |
| Linezolid | Number of Patients at the Early Assessment Visit With a 20% Reduction in ABSSSI Lesion Size Compared to Baseline | 35 Participants |
Secondary
Number of Patients at EOT With a 80% Reduction in ABSSSI Lesion Size Compared to Baseline
Time frame: Day 10
Population: Intent-to-Treat (ITT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MRX-I | Number of Patients at EOT With a 80% Reduction in ABSSSI Lesion Size Compared to Baseline | 70 Participants |
| Linezolid | Number of Patients at EOT With a 80% Reduction in ABSSSI Lesion Size Compared to Baseline | 32 Participants |