NCT07379684 A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic Wound Infections
| NCT ID | NCT07379684 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Macro Biologics, Inc. |
| Condition | Surgical Wound Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2026-09-30 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 44 participants in total. It began in 2026-09-30 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07379684 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Surgical Wound Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07379684 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07379684 currently recruiting?
Yes, NCT07379684 is actively recruiting participants. Contact the research team at dgowenhuang@macrobiologics.com for enrollment information.
Where is the NCT07379684 trial being conducted?
This trial is being conducted at Torrance, United States, Idaho Falls, United States, Baltimore, United States, St Louis, United States and 1 additional location.
Who is sponsoring the NCT07379684 clinical trial?
NCT07379684 is sponsored by Macro Biologics, Inc.. The trial plans to enroll 44 participants.