Amicidin-β topical treatment for infected surgical and traumatic wounds

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

This Phase 1 trial will test whether applying Amicidin-β topical solution into infected surgical or traumatic wounds during a procedure is safe and how much of the drug enters the bloodstream for adults who need wound intervention.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 79 Years
• Sex: All
• Sponsor: Macro Biologics, Inc. (Industry-sponsored)
• Locations: 4 sites (Torrance, California and 3 other locations)
• Trial ID: NCT07379684 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, standard-of-care controlled, randomized study enrolling about 44 patients in three sequential cohorts (8, 12, and 24 patients) to receive either standard wound care alone or standard care plus intrawound Amicidin-β in a 1:3 ratio. The investigational solution is applied directly into infected wounds during an interventional procedure such as incision, drainage, irrigation, or debridement. Primary objectives are to characterize safety, local tolerability, systemic absorption, and ease of use by the surgeon, with follow-up over the study period. Eligible wounds are surgical or traumatic infections within 90 days of the inciting event and between 3 and 15 cm in longest dimension, with BMI and contraception requirements specified for enrollment.

Who should consider this trial

Good fit: Adults with a surgical or traumatic wound infection (3–15 cm longest dimension) requiring an interventional procedure within 90 days of surgery or trauma, with BMI 18.5–39.9 kg/m2 and agreement to required contraception for women of childbearing potential, are ideal candidates.

Not a fit: Patients with wounds outside the 3–15 cm size range, those not requiring an interventional procedure, pregnant patients, or those with contraindications to the study drug are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, Amicidin-β could offer a locally applied antimicrobial option that helps control wound infections while limiting systemic antibiotic exposure.

How similar studies have performed: Topical and intrawound antimicrobial approaches have shown mixed results in prior work and this specific Amicidin-β application is an early-phase, relatively novel approach with limited human data.

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 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

Where this trial is running

Torrance, California and 3 other locations

• Lundquist Institute — Torrance, California, United States (Recruiting)
• Snake River Research, PLLC — Idaho Falls, Idaho, United States (Recruiting)
• LifeBridge Health — Baltimore, Maryland, United States (Recruiting)
• The Ohio State University — Columbus, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Daniel J Gowen-Huang, MBA

Conditions Surgical Wound Infection; Traumatic Wound Infection; Surgical wound infection; Traumatic wound infection