Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07379684 | A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic Wound Infections | PHASE1 | RECRUITING | 44 | — | — | May 31, 2026 | Feb 28, 2027 | May 6, 2026 | 4 | United States |
| Arm | Type | Description |
|---|---|---|
| SOC + Amicidin-β topical solution - 15 mL | EXPERIMENTAL | In addition to Standard of Care (SOC), patients will receive Amicidin-β topical solution - 15 mL immediately prior to wound closure/dressing, with rinsing out with saline. |
| SOC + Amicidin-β topical solution - 50 mL - Scheme 1 | EXPERIMENTAL | In addition to Standard of Care (SOC), patients will be receive Amicidin-β topical solution - 50 mL immediately prior to wound closure/dressing, with rinsing out with saline |
| SOC + Amicidin-β topical solution - 50 mL - Scheme 2 | EXPERIMENTAL | In addition to Standard of Care (SOC), patients will be receive Amicidin-β topical solution - 50 mL immediately prior to wound closure/dressing, without rinsing out with saline |
| SOC | ACTIVE_COMPARATOR | Patients will receive Standard of Care (SOC) only |
| Name | Type | Description |
|---|---|---|
| Amicidin-β topical solution - 15 mL | DRUG | Amicidin-β topical solution for local administration - 15 mL |
| Amicidin-β topical solution - 50 mL | DRUG | Amicidin-β topical solution for local administration - 50 mL |
| Standard of Care (SOC) | DRUG | Per institutional Standard Of Care |
Main Inclusion Criteria: * Body Mass Index between 18.5 kg/square meter and 39.9kg/square meter * Surgical or traumatic wound determined by the Investigator to be infected within 90 days of surgery or trauma, with longest dimension between 3 and 15 cm. The diagnosis should include one or more of th...