A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic Wound Infections

Официальное название

A Phase 1 Study to Assess Safety and Tolerability of Amicidin-β Topical Solution in Adult Patients Undergoing Interventional Management of a Surgical or Traumatic Wound Infection

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Amicidin-β topical solution - 15 mL
  Amicidin-β topical solution for local administration - 15 mL
• Препарат Amicidin-β topical solution - 50 mL
  Amicidin-β topical solution for local administration - 50 mL
• Препарат Standard of Care (SOC)
  Per institutional Standard Of Care

Первичные конечные точки

• Overall comparison of treatment emergent adverse events (TEAES) of combined SOC + Amicidin-β topical solution recipients to SOC only recipients across 3 cohorts. [Срок оценки: From Day 1 to Day 30]

Вторичные конечные точки (2)

• Number of participants with Treatment Emergent Adverse Events (TEAEs) by severity according to the study protocol. [Срок оценки: From Day 1 to Day 30]
• Measurement of systemic absorption of Amicidin-β recipients. [Срок оценки: From Day 1 to Day 3]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Lundquist Institute — Torrance
• Snake River Research, PLLC — Idaho Falls
• LifeBridge Health — Baltimore
• Washington University in St. Louis — St Louis
• The Ohio State University — Columbus

Идентификаторы

NCT: NCT07379684 · BETA-TS-001 · 224842/Z/21/Z · Agreement dated 02/28/2023 · Agreement Dated 01/30/2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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