NCT07379684 · Macro Biologics, Inc.
A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic Wound Infections
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Amicidin-β topical solution - 15 mL
Amicidin-β topical solution for local administration - 15 mL
DRUG
Amicidin-β topical solution - 50 mL
Amicidin-β topical solution for local administration - 50 mL
DRUG
Standard of Care (SOC)
Per institutional Standard Of Care
Primary outcome measures
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 30
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Torrance, California
- Idaho Falls, Idaho
- Baltimore, Maryland
- Columbus, Ohio
Collaborators
Biomedical Advanced Research and Development Authority, Novo Nordisk Foundation (NNF23SA0088536), 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
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations