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 IV iclaprim compared to IV 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 |
|---|---|---|
| Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline | Baseline and 48 to 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 |
|---|---|---|
| Number of Participants With 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
Argentina, Belgium, Croatia, Czechia, Estonia, Hungary, Portugal, Romania, Turkey (Türkiye), United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Iclaprim iclaprim 80 mg intravenous every 12 hours
Iclaprim: Experimental treatment | 295 |
| Vancomycin vancomycin 15 mg/kg intravenous every 12, 24 or 48 hours based on creatinine clearance
Vancomycin: Active comparator | 305 |
| Total | 600 |
Baseline characteristics
| Characteristic | Vancomycin | Iclaprim | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 55 Participants | 55 Participants | 110 Participants |
| Age, Categorical Between 18 and 65 years | 250 Participants | 240 Participants | 490 Participants |
| Age, Continuous | 50.8 years STANDARD_DEVIATION 15 | 50.0 years STANDARD_DEVIATION 15.7 | 50.4 years STANDARD_DEVIATION 15.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 94 Participants | 99 Participants | 193 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 207 Participants | 193 Participants | 400 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 12 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 12 Participants | 21 Participants |
| Race (NIH/OMB) White | 276 Participants | 267 Participants | 543 Participants |
| Region of Enrollment Argentina | 3 participants | 9 participants | 12 participants |
| Region of Enrollment Belgium | 0 participants | 2 participants | 2 participants |
| Region of Enrollment Croatia | 12 participants | 10 participants | 22 participants |
| Region of Enrollment Czechia | 3 participants | 4 participants | 7 participants |
| Region of Enrollment Estonia | 48 participants | 36 participants | 84 participants |
| Region of Enrollment Hungary | 5 participants | 4 participants | 9 participants |
| Region of Enrollment Mexico | 3 participants | 2 participants | 5 participants |
| Region of Enrollment Portugal | 5 participants | 3 participants | 8 participants |
| Region of Enrollment Romania | 14 participants | 20 participants | 34 participants |
| Region of Enrollment Turkey | 7 participants | 5 participants | 12 participants |
| Region of Enrollment United States | 205 participants | 200 participants | 405 participants |
| Sex: Female, Male Female | 108 Participants | 103 Participants | 211 Participants |
| Sex: Female, Male Male | 197 Participants | 192 Participants | 389 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 299 | 1 / 302 |
| other Total, other adverse events | 0 / 299 | 1 / 302 |
| serious Total, serious adverse events | 0 / 299 | 1 / 302 |
Outcome results
Primary
Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline
≥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 to 72 hours after first dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Iclaprim | Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline | 78.3 percentage of participants |
| Vancomycin | Percent of Participants With ≥20% Reduction in Lesion Size at 48 to 72 Hours Compared to Baseline | 76.7 percentage of participants |
Secondary
Number of Participants With 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Iclaprim | Number of Participants With Resolution or Near Resolution of Lesion at Test of Cure Visit | 229 participants |
| Vancomycin | Number of Participants With Resolution or Near Resolution of Lesion at Test of Cure Visit | 237 participants |