Clinical trial NCT05369052: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Diabetic Foot Infection
Lead sponsor: MicuRx
Sponsor class: INDUSTRY
First posted: 2022-05-11
Enrollment: 865
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators
timeFrame: Day 35
measure: Adverse events - symptoms reported by subjects
timeFrame: 28-35 days after End-of-Therapy (EOT)
measure: Clinical laboratory assessment - complete blood count
timeFrame: 28-35 days after End-of-Therapy (EOT)
measure: Vital signs - heart rate
timeFrame: 28-35 days after End-of-Therapy (EOT)
Secondary outcomes:
measure: Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators
timeFrame: 14-28 days
measure: Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators
timeFrame: Day 10, 28-35 days after EOT
Other outcomes:
Locations:
city: Corona
country: United States
facility: New Hope Research Development
state: California
city: Los Angeles
country: United States
facility: Clemente Clinical Research
state: California
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
city: Whittier
country: United States
facility: PIH Health Whittier Hospital
state: California
city: Miami
country: United States
facility: University Medical and Research Center, LLC
state: Florida
city: Vero Beach
country: United States
facility: Infectious Diseases Consultants of the Treasure Coast
state: Florida
city: Somers Point
country: United States
facility: South Jersey Infectious Disease
state: New Jersey
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Sanatorio Guemes
city: Corrientes
country: Argentina
facility: Centro Universitario de Investigacion Clinica
city: Córdoba
country: Argentina
facility: Clinica Chutro
city: Córdoba
country: Argentina
facility: Hospital Rawson
city: Córdoba
country: Argentina
facility: Hospital San Roque
city: La Plata
country: Argentina
facility: Instituto Medico Platense
city: Mar Del Plata
country: Argentina
facility: Centro de Investigaciones Medicas Mar Del Plata
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS
city: Rio Grande
country: Brazil
facility: Centro de Estudos e Pesquisas Em Molestias Infecciosas Ltda CPCLIN
city: Lom
country: Bulgaria
facility: MHAT Sveti Nikolay Chudotvorets EOOD
city: Plovdiv
country: Bulgaria
facility: UMHAT - Sveti Georgi EAD
city: Ruse
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - KANEV
city: Sofia
country: Bulgaria
facility: Medical Institute Ministry of Interior Central Clinical Base
city: Sofia
country: Bulgaria
facility: University Multidisciplinary Hospital for Active Treatment and Emergency Medicine 'N. I. Priogov´
city: Stara Zagora
country: Bulgaria
facility: UMHAT - Prof. Stoyan Kirkovich
city: Santiago
country: Chile
facility: Biomedica Research Group
city: Viña Del Mar
country: Chile
facility: Hospital Gustavo Fricke
city: Shantou
country: China
facility: The Second Affiliated Hospital of Shantou University Medical Center
state: Guangdong
city: Nanning
country: China
facility: The Second Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Xi'an
country: China
facility: Xi'an Medical University First Affiliated Hospital
state: Shaanxi
city: Chengdu
country: China
facility: West China Hospital Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
city: Chongqing
country: China
facility: Chongqing No. 4 People's Hospital
state: Sichuan
city: Tianjing
country: China
facility: Chu Hsien-I Memorial Hospital of Tianjin Medical University
state: Tianjin
city: Kunming
country: China
facility: Affiliated Hospital of Yunnan University
state: Yunnan
city: Slavonski Brod
country: Croatia
facility: General Hospital Slavonski Brod
city: Zagreb
country: Croatia
facility: Clinical Hospital Merkur
city: Kohtla-Järve
country: Estonia
facility: Ida-Viru Central Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Võru
country: Estonia
facility: South-Estonian Hospital Ltd.
city: Batumi
country: Georgia
facility: LTD High Technology Hospital Med Center
city: Kutaisi
country: Georgia
facility: JSC Vian - West Georgia Medical Center
city: Tbilisi
country: Georgia
facility: Healthycore
city: Tbilisi
country: Georgia
facility: Tbilisi Heart Center
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zvezdara
city: Belgrade
country: Serbia
facility: Institute of Cardiovascular Diseases Dedinje
city: Bratislava
country: Slovakia
facility: Univerzitna Nemocnica Bratislava
city: Trnava
country: Slovakia
facility: Fakultna Nemocnica Trnava
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
state: Gipuzkoa
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
References: