A Study of Amicidin-β Topical Solution for Patients With a Contaminated or Infected Surgical or Traumatic Wound or Cutaneous Abscess

Macro Biologics, Inc.

Status and phase: Enrolling; Phase 1

Conditions: Cutaneous Abscess; Traumatic Wound Infection; Surgical Wound Infection

Treatments: Drug: Amicidin-β topical solution - 50 mL; Drug: Amicidin-β topical solution - 15 mL; Drug: Standard of Care (SOC)

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT07379684

BETA-TS-001

Agreement Dated 01/30/2023 (Other Grant/Funding Number)

224842/Z/21/Z (Other Grant/Funding Number)

Details and patient eligibility

About

The goal of this Phase 1 clinical trial is to learn about the safety profile of Amicidin-β topical solution applied directly into contaminated or infected surgical or traumatic wounds or cutaneous abscess 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.

Full description

This is a Standard of Care (SOC)- controlled study of approximately 44 patients divided into three sequential cohorts of 8, 12, and 24 patients. Within each sequential cohort, patients will be randomized to SOC only or to SOC plus Amicidin-β topical solution in a 1:3 ratio.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Surgical or traumatic wound ≤90 days old or a cutaneous abscess that is:

  1. ≥3 cm in length of longest dimension;
  2. requires an interventional procedure, such as opening, incision, drainage, irrigation, and/or debridement; and
  3. is anticipated by the Investigator to be Class III (contaminated) or Class IV (dirty/infected).

• 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:

• Wound or cutaneous abscess associated with surrounding cellulitis extending ≥10 cm from the wound edge;
• Suspected necrotizing fasciitis or gangrenous ulcer. Necrotizing fasciitis is understood to be a rare severe form of necrotizing soft tissue infection (NSTI). Patients with limited tissue necrosis surrounding an infection or with diagnosis of NSTI that is not considered by the Investigator to be severe and rapidly progressive are eligible. If necrotizing fasciitis is confirmed during the interventional procedure, the patient should be withdrawn immediately and patient should be treated with SoC;
• Multiple wounds at different sites determined to be Class III (contaminated) or Class IV (dirty/infected);
• Wound infection overlying bone fracture, with radiological evidence of non-union. A Class III or Class IV wound over a healed bone fracture is not exclusionary;
• Wound infection with open peritoneal cavity;
• Wound with infection extending to an organ space;
• Wound with infection extending to implanted surgical hardware or protesis. Note: surgical drains and packing are permitted;
• Wound or cutaneous abscess on head and neck;
• Wound or cutaneous abscess on hands or feet;
• Wound or cutaneous abscess involving burn injury;
• Suspected or confirmed osteomyelitis or septic arthritis;
• Wound contamination or infection or cutaneous abscess known or suspected to be caused by fungal (other than Candida spp.) or by mycobacterial organisms;
• Wound or cutaneous abscess on a lower extremity that also has a neuropathic or diabetic foot ulcer or a previous diagnosis of moderate to severe chronic venous insufficiency;
• Patient requires long-term supplemental O2 or mechanical ventilation. Patients requiring short-term supplemental O2 prior to, during, or post-interventional procedure are eligible;
• 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;
• Uncontrolled insulin-dependent diabetes mellitus or diagnosis of diabetes mellitus which, in the opinion of the Investigator, is poorly controlled;
• Profound immunosuppression (e.g., induction therapy);
• Diagnosis of genetic hypercoagulable state (e.g., anti-phospholipid syndrome, Factor V Leiden, prothrombin gene mutation);
• History in the last 12 months of myocardial infarction, coronary artery disease requiring interventional treatment (e.g., angioplasty / stenting, bypass), stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism, or antithrombotic therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

44 participants in 4 patient groups

SOC + Amicidin-β topical solution - 15 mL

Experimental group

Description:

In addition to Standard of Care (SOC), patients will receive Amicidin-β topical solution - 15 mL immediately prior to wound closure/dressing, with rinsing out with saline.

Treatment:

Drug: Standard of Care (SOC)

Drug: Amicidin-β topical solution - 15 mL

SOC + Amicidin-β topical solution - 50 mL - Scheme 1

Experimental group

Description:

In addition to Standard of Care (SOC), patients will be receive Amicidin-β topical solution - 50 mL immediately prior to wound closure/dressing, with rinsing out with saline

Treatment:

Drug: Standard of Care (SOC)

Drug: Amicidin-β topical solution - 50 mL

SOC + Amicidin-β topical solution - 50 mL - Scheme 2

Experimental group

Description:

In addition to Standard of Care (SOC), patients will be receive Amicidin-β topical solution - 50 mL immediately prior to wound closure/dressing, without rinsing out with saline

Treatment:

Drug: Standard of Care (SOC)

Drug: Amicidin-β topical solution - 50 mL

SOC

Active Comparator group

Description:

Patients will receive Standard of Care (SOC) only

Treatment:

Drug: Standard of Care (SOC)