Safety and Efficacy Study of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)

Официальное название

A Phase 3, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Contezolid Acefosamil and Contezolid Compared to Linezolid Administered Intravenously and Orally to Adults With Moderate or Severe Diabetic Foot Infections (DFI)

Обзор

This is a Phase 3, multicenter, randomized, double-blind, safety and efficacy study of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO) administered for a total of 14 to 28 days in adult subjects with moderate or severe DFI.

Подробное описание

Approximately 865 subjects (519 contezolid acefosamil/contezolid: 346 linezolid) will be enrolled with moderate or severe DFI that are confirmed or suspected to be due to a Gram-positive bacterial pathogen (MITT analysis set).

Вмешательства

• Препарат contezolid acefosamil (IV)/contezolid (PO)
  Contezolid acefosamil (IV)/contezolid (PO) administered for a total of 14 to 28 days (28 to 56 doses)
• Препарат Linezolid (IV and PO)
  Linezolid (IV and PO) administered for a total of 14 to 28 days (28 to 56 doses)

Первичные конечные точки

• Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators [Срок оценки: Day 35]
• Adverse events - symptoms reported by subjects [Срок оценки: 28-35 days after End-of-Therapy (EOT)]
• Clinical laboratory assessment - complete blood count [Срок оценки: 28-35 days after End-of-Therapy (EOT)]
• Vital signs - heart rate [Срок оценки: 28-35 days after End-of-Therapy (EOT)]

Вторичные конечные точки (2)

• Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators [Срок оценки: 14-28 days]
• Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators [Срок оценки: Day 10, 28-35 days after EOT]

Критерии участия

Критерии включения

• Have diabetes mellitus (type 1 or 2) per the American Diabetes Association criteria
• Have a foot infection that started at or below the malleolus and does not extend above the knee
• Foot infection that meets the IWGDF DFI criteria for classification 3 (moderate infection) or 4 (severe infection)
• Foot infection had acute onset or worsening of signs and symptoms within the past 14 days

Критерии исключения

• Previous DFI known or suspected to be caused by Gram-positive pathogens that are resistant to oxazolidinone antibiotics
• DFI with presumptive evidence or suspicion of osteomyelitis
• Necrotizing fasciitis, crepitant cellulitis, wet gangrene, gas gangrene, ecthyma gangrenosum, septic arthritis, or severely impaired arterial supply to any portion of the affected foot which may need revascularization before the end of the study
• Evidence of significant hepatic, renal, hematologic, or immunologic disease
• Females who are pregnant or breastfeeding
• Prior receipt of any formulation of contezolid acefosamil or contezolid
• Inability to cooperate fully with the requirements of the study protocol, including the schedule of events, or likely to be noncompliant with any study requirements, or the Investigator determines that the subject should not participate in the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Болгария · 4 центра

• MHAT Sveti Nikolay Chudotvorets EOOD — Lom
• Multiprofile Hospital for Active Treatment - KANEV — Rousse
• Medical Institute Ministry of Interior Central Clinical Base — Sofia
• University Multidisciplinary Hospital for Active Treatment and Emergency Medicine 'N. I. P — Sofia

США · 2 центра

• New Hope Research Development — Corona
• ILD Research Center — Vista

Грузия · 2 центра

• LTD High Technology Hospital Med Center — Batumi
• JSC Vian - West Georgia Medical Center — Kutaisi

Польша · 2 центра

• Instytut Medycyny Wsi im. W. Chodzki — Lublin
• PODEMA Sp. z o.o. — Warsaw

Эстония · 1 центр

• South-Estonian Hospital Ltd. — Võru

Италия · 1 центр

• GMV Care& Research - Maria Cecilia Hospital — Cotignola

Латвия · 1 центр

• Daugavpils Regional Hospital — Daugavpils

Сербия · 1 центр

• University Clinical Center Kragujevac — Kragujevac

Идентификаторы

NCT: NCT05369052 · MRXC-302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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