A Phase 1 Study to Assess Safety and Tolerability of Amicidin-β Topical Solution in Adult Patients Undergoing Interventional Management of a Surgical or Traumatic Wound Infection
| Registry | NCT07379684 |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional; randomized, sequential, masking: none, treatment |
| Enrollment | 44 (Estimated) |
| Sponsor | Macro Biologics, Inc. (Industry); collaborators: Biomedical Advanced Research and Development Authority, Novo Nordisk Foundation, Global Antimicrobial Resistance Innovation Fund-(GAMRIF), US NIH Grant/Contract Award Number: HHS/BARDA OTA No. 75A50122C00028, Wellcome Trust 224842/Z/21/Z, Germany's Federal Ministry of Education and Research (BMBF) Agreement Dated 1/30/23, UK Secretary of State for Health and Social Care ("DHSC"), Agreement dated 02/28/2023 |
| Conditions | Surgical Wound Infection, Traumatic Wound Infection |
| Interventions | Amicidin-β topical solution - 15 mL, Amicidin-β topical solution - 50 mL, Standard of Care (SOC) (Drug) |
| Dates | start 2026-09-30 (estimated), primary completion 2027-02-28 (estimated), completion 2027-02-28 (estimated), first posted 2026-01-30, last updated 2026-08-17 |
| Locations | 5 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Surgical Wound Infection All trials for Traumatic Wound Infection All trials of Amicidin-β topical solution - 15 mL All trials of Amicidin-β topical solution - 50 mL
The goal of this Phase 1 clinical trial is to learn about the safety profile of Amicidin-β topical solution applied directly into infected surgical or traumatic wounds during a surgical procedure. The main questions it aims to answer are:
1. Is Amicidin-β topical solution safe to test in larger clinical trials?
2. Is Amicidin-β topical solution absorbed into the bloodstream from local wound application?
3. Is Amicidin-β topical solution easy for the surgeon to use? Participants will receive either standard of care alone, or standard of care with intrawound Amicidin-β topical solution for the management of their wound infection. Researchers will compare these two groups (standard of care alone to standard of care with Amicidin-β topical solution) to see if there are any study drug-related adverse effects.
This is a Standard of Care (SOC)- controlled study of approximately 44 patients divided into three sequential cohorts of 8, 12, and 24 patients. Within each sequential cohort, patients will be randomized to SOC only or to SOC plus Amicidin-β topical solution in a 1:3 ratio.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| SOC + Amicidin-β topical solution - 15 mL | Experimental | Drug: Amicidin-β topical solution - 15 mL; Drug: Standard of Care (SOC) | 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 | Drug: Amicidin-β topical solution - 50 mL; Drug: Standard of Care (SOC) | 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 | Drug: Amicidin-β topical solution - 50 mL; Drug: Standard of Care (SOC) | 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 | Drug: Standard of Care (SOC) | Patients will receive Standard of Care (SOC) only |
Sex: All, ages: 18 Years to 79 Years
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 the following signs or symptoms: * Purulent drainage * Erythema * Surrounding induration * Fever or localized heat surrounding the wound * Reported localized pain or localized tenderness on examination * Infected surgical or traumatic wound that is determined by the Investigator to required an interventional procedure, such as incision, drainage, irrigation, and/or debridement. * If female of childbearing potential, must have been practicing an acceptable method of birth control as judged by the Investigator for at least one month prior to enrollment. * Females of childbearing potential must agree that for the entire duration of the study (about 30 days), they will either practice true abstinence consistent with their preferred and usual lifestyle, or use double contraceptive methods. Main Exclusion Criteria: Patients with any of the following will be excluded: * Surgical or traumatic wound associated with surrounding cellulitis extending ≥10 cm from the wound edge * Confirmed necrotizing fasciitis or gangrenous ulcer * Multiple surgical or traumatic wound infections at different sites * Surgical or traumatic wound infection overlying bone fracture, with radiological evidence of non-union * Surgical or traumatic wound infection with open peritoneal cavity * Surgical or traumatic wound infection extending to an organ space * Surgical or traumatic wound infection extending to implanted surgical hardware or protesis. Note: surgical drains and packing are permitted * Surgical or traumatic wound infection involving head and neck * Surgical or traumatic wound infection involving burn injury * Suspected or confirmed osteomyelitis or septic arthritis * Surgical or traumatic wound infection known or suspected to be caused by fungal or mycobacterial organisms * Wound with diagnosis of neuropathic or diabetic foot ulcer or a previous diagnosis of moderate to severe chronic venous insufficiency of a lower extremity in patients with an infected surgical to traumatic wound of the lower extremity * Wound due to malignancy * Antibiotic therapy for an infection other than the surgical or traumatic wound infection * Patient requires supplemental O2 or mechanical ventilation * Pulse Oximetry (SpO2) reading of ≤ 92% on room air (confirmed by two additional readings ≤92% over 15 min). At geographic locations of high altitude, a lower SpO2 limit (e.g., ≤ 91%) may be used at Investigator's discretion
| Facility | City | Country | Status |
|---|---|---|---|
| Lundquist Institute | Torrance, California | United States | Recruiting |
| Snake River Research, PLLC | Idaho Falls, Idaho | United States | Recruiting |
| LifeBridge Health | Baltimore, Maryland | United States | Recruiting |
| Washington University in St. Louis | St Louis, Missouri | United States | Recruiting |
| The Ohio State University | Columbus, Ohio | United States | Recruiting |