Amicidin-β topical treatment for infected surgical and traumatic wounds

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, standard-of-care controlled, randomized study enrolling about 44 patients in three sequential cohorts (8, 12, and 24 patients) to receive either standard wound care alone or standard care plus intrawound Amicidin-β in a 1:3 ratio. The investigational solution is applied directly into infected wounds during an interventional procedure such as incision, drainage, irrigation, or debridement. Primary objectives are to characterize safety, local tolerability, systemic absorption, and ease of use by the surgeon, with follow-up over the study period. Eligible wounds are surgical or traumatic infections within 90 days of the inciting event and between 3 and 15 cm in longest dimension, with BMI and contraception requirements specified for enrollment.

Why it matters

Who can join: the full rules

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 If necrotizing fasciitis is confirmed during the interventional procedure, the patient should be withdrawn immediately and patient should be treated with SoC;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.

Where it's running

• Lundquist Institute
  Torrance, California, United States Recruiting
• Snake River Research, PLLC
  Idaho Falls, Idaho, United States Recruiting
• LifeBridge Health
  Baltimore, Maryland, United States Recruiting
• Washington University in St. Louis
  St Louis, Missouri, United States Recruiting
• The Ohio State University
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Daniel J Gowen-Huang, MBA
• Email: dgowenhuang@macrobiologics.com
• Phone: (323) 717-0302

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.