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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Amicidin-β topical solution - 15 mL
DrugAmicidin-β topical solution for local administration - 15 mL
Amicidin-β topical solution - 50 mL
DrugAmicidin-β topical solution for local administration - 50 mL
Standard of Care (SOC)
DrugPer institutional Standard Of Care
Treatment groups
44 Participants
are divided into 4 treatment groupsGroup A: SOC + Amicidin-β topical solution - 15 mLExperimental treatment 2 interventions
Group B: SOC + Amicidin-β topical solution - 50 mL - Scheme 1Experimental treatment 2 interventions
Group C: SOC + Amicidin-β topical solution - 50 mL - Scheme 2Experimental treatment 2 interventions
Group D: SOCActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Overall comparison of treatment emergent adverse events (TEAES) of combined SOC + Amicidin-β topical solution recipients to SOC only recipients across 3 cohorts.
Time frame
From Day 1 to Day 30Secondary outcomes
1
Number of participants with Treatment Emergent Adverse Events (TEAEs) by severity according to the study protocol.
Time frame
From Day 1 to Day 302
Measurement of systemic absorption of Amicidin-β recipients.
Systemic absorption will be assessed by single molecule array (Simoa) immunoassay measurements of patient plasma.
Time frame
From Day 1 to Day 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Macro Biologics, Inc.
Lead sponsor
Biomedical Advanced Research and Development Authority
Collaborator
Novo Nordisk Foundation
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
Source ClinicalTrials.gov