Status:
RECRUITING
A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic Wound Infections
Lead Sponsor:
Macro Biologics, Inc.
Collaborating Sponsors:
Biomedical Advanced Research and Development Authority
Novo Nordisk Foundation (NNF23SA0088536)
Conditions:
Surgical Wound Infection
Traumatic Wound Infection
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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 randomi...
Eligibility Criteria
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 30 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
- Necrotizing fasciitis or gangrenous ulcer
- Multiple surgical or traumatic wound infections at different sites
- Surgical or traumatic wound infection overlying unhealed bone fracture
- Surgical or traumatic wound infection with open peritoneal cavity
- Surgical or traumatic wound infection extending to an organ space
- Surgical or traumatic wound infection with or adjacent to implanted surgical hardware. 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
Key Trial Info
Start Date :
April 30 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT07379684
Start Date
April 30 2026
End Date
February 28 2027
Last Update
April 9 2026
Active Locations (4)
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1
Lundquist Institute
Torrance, California, United States, 90502
2
Snake River Research, PLLC
Idaho Falls, Idaho, United States, 83404
3
LifeBridge Health
Baltimore, Maryland, United States, 21215
4
The Ohio State University
Columbus, Ohio, United States, 43210