A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic Wound Infections

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-79
SponsorMacro Biologics, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Body Mass Index between 18.5 kg/square meter and 39.9kg/square meter

Purulent drainage

Erythema

Surrounding induration

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Amicidin-β topical solution - 15 mL
  • Amicidin-β topical solution - 50 mL
  • Standard of Care (SOC)

Treatment groups

44 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Macro Biologics, Inc.

Lead sponsor

Biomedical Advanced Research and Development Authority

Collaborator

Novo Nordisk Foundation (NNF23SA0088536)

Collaborator

Global Antimicrobial Resistance Innovation Fund-(GAMRIF)

Collaborator

US NIH Grant/Contract Award Number: HHS/BARDA OTA No. 75A50122C00028

Collaborator

Wellcome Trust 224842/Z/21/Z

Collaborator

Germany's Federal Ministry of Education and Research (BMBF) Agreement Dated 1/30/23

Collaborator

UK Secretary of State for Health and Social Care ("DHSC"), Agreement dated 02/28/2023

Collaborator