Skin Structures and Soft Tissue Infections
Conditions
Brief summary
This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin for the treatment of skin and skin structure infections.
Detailed description
This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin. Patients will receive either iclaprim or vancomycin for 5 to 14 days. Patients will be evaluated daily up to early time point (ETP), then every 48 to 72 hours through the end of treatment. Patients will also be evaluated at the test of cure (TOC) visit (7 to 14 days post-EOT), and will have a Late Follow-Up (LFU) visit (28 to 32 days post-first dose).
Interventions
DRUGiclaprim
Experimental treatment
DRUGvancomycin
Active comparator
Sponsors
Motif Bio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. written informed consent; 2. ≥18 years of age; 3. a bacterial infection of the skin with a lesion size area of at least 75 cm2; 4. a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections; 5. the presence of purulent or seropurulent drainage or at least three signs and symptoms of infection (discharge, erythema, swelling, warmth, or pain).
Exclusion criteria
1. severely impaired arterial blood supply such that amputation of the infected anatomical site is likely; 2. infected diabetic foot ulcers; 3. infected decubitus ulcers; 4. necrotizing fasciitis or gangrene; 5. uncomplicated skin or skin structure infection; 6. infections associated with a prosthetic device; 7. suspected or confirmed osteomyelitis; 8. conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline in All Randomized Patients. | Baseline and 48-72 hours after first dose of study drug | ≥20% reduction in lesion size at 48 to 72 hours (Early Time Point \[ETP\]) compared to baseline in all randomized patients (ITT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resolution or Near Resolution of Lesion at Test of Cure Visit | 7 to14 days after the end of treatment | Resolution or near resolution of lesion at Test of Cure (TOC) visit |
Countries
Bulgaria, Chile, Colombia, Germany, Latvia, Peru, Poland, Puerto Rico, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Iclaprim iclaprim 80 mg intravenous every 12 hours
iclaprim: Experimental treatment | 298 |
| Vancomycin vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance
vancomycin: Active comparator | 300 |
| Total | 598 |
Baseline characteristics
| Characteristic | Iclaprim | Vancomycin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 58 Participants | 60 Participants | 118 Participants |
| Age, Categorical Between 18 and 65 years | 240 Participants | 240 Participants | 480 Participants |
| Age, Continuous | 46.4 years STANDARD_DEVIATION 13.3 | 48.2 years STANDARD_DEVIATION 14.8 | 47.8 years STANDARD_DEVIATION 14.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants | 31 Participants | 63 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 266 Participants | 269 Participants | 535 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 28 Participants | 24 Participants | 52 Participants |
| Race (NIH/OMB) White | 266 Participants | 269 Participants | 535 Participants |
| Region of Enrollment Bulgaria | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment Latvia | 4 Participants | 4 Participants | 8 Participants |
| Region of Enrollment Peru | 2 Participants | 3 Participants | 5 Participants |
| Region of Enrollment Puerto Rico | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment Ukraine | 11 Participants | 11 Participants | 22 Participants |
| Region of Enrollment United States | 219 Participants | 200 Participants | 419 Participants |
| Sex: Female, Male Female | 109 Participants | 129 Participants | 238 Participants |
| Sex: Female, Male Male | 189 Participants | 171 Participants | 360 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 298 | 2 / 300 |
| other Total, other adverse events | 151 / 298 | 128 / 300 |
| serious Total, serious adverse events | 9 / 298 | 14 / 300 |
Outcome results
Primary
≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline in All Randomized Patients.
≥20% reduction in lesion size at 48 to 72 hours (Early Time Point \[ETP\]) compared to baseline in all randomized patients (ITT).
Time frame: Baseline and 48-72 hours after first dose of study drug
Population: all randomized patients (ITT).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Iclaprim | ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline in All Randomized Patients. | 80.9 percentage of participants |
| Vancomycin | ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline in All Randomized Patients. | 81.0 percentage of participants |
Secondary
Resolution or Near Resolution of Lesion at Test of Cure Visit
Resolution or near resolution of lesion at Test of Cure (TOC) visit
Time frame: 7 to14 days after the end of treatment
Population: all randomized patients (ITT population)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Iclaprim | Resolution or Near Resolution of Lesion at Test of Cure Visit | 248 participants |
| Vancomycin | Resolution or Near Resolution of Lesion at Test of Cure Visit | 262 participants |