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)
- Conditions
- Diabetic Foot Infection
- Interventions
- Registration Number
- NCT05369052
- Lead Sponsor
- MicuRx
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 865
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description contezolid acefosamil/contezolid contezolid acefosamil (IV)/contezolid (PO) - linezolid Linezolid (IV and PO) -
- Primary Outcome Measures
Name Time Method Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators Day 35 The primary objective is to evaluate the Investigator's assessment of clinical response at the D35 visit in subjects receiving contezolid acefosamil/contezolid compared to subjects receiving linezolid in the MITT analysis
Clinical laboratory assessment - complete blood count 28-35 days after End-of-Therapy (EOT) Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)
Vital signs - heart rate 28-35 days after End-of-Therapy (EOT) Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)
Adverse events - symptoms reported by subjects 28-35 days after End-of-Therapy (EOT) Evaluate safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)
- Secondary Outcome Measures
Name Time Method Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators Day 10, 28-35 days after EOT Evaluate the Investigator's assessment of clinical response at Day 10 (D10) and Late Follow-Up visits (LFU; 28-35 days after EOT) in the MITT analysis set
Trial Locations
- Locations (55)
New Hope Research Development
🇺🇸Corona, California, United States
Clemente Clinical Research
🇺🇸Los Angeles, California, United States
VA Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
PIH Health Whittier Hospital
🇺🇸Whittier, California, United States
University Medical and Research Center, LLC
🇺🇸Miami, Florida, United States
Infectious Diseases Consultants of the Treasure Coast
🇺🇸Vero Beach, Florida, United States
South Jersey Infectious Disease
🇺🇸Somers Point, New Jersey, United States
Hospital Italiano de Buenos Aires
🇦🇷Buenos Aires, Argentina
Sanatorio Guemes
🇦🇷Buenos Aires, Argentina
Centro Universitario de Investigacion Clinica
🇦🇷Corrientes, Argentina
Clinica Chutro
🇦🇷Córdoba, Argentina
Hospital Rawson
🇦🇷Córdoba, Argentina
Hospital San Roque
🇦🇷Córdoba, Argentina
Instituto Medico Platense
🇦🇷La Plata, Argentina
Centro de Investigaciones Medicas Mar Del Plata
🇦🇷Mar Del Plata, Argentina
Hospital Ernesto Dornelles
🇧🇷Porto Alegre, Brazil
Hospital Sao Lucas da PUCRS
🇧🇷Porto Alegre, Brazil
Centro de Estudos e Pesquisas Em Molestias Infecciosas Ltda CPCLIN
🇧🇷Rio Grande, Brazil
Affiliated Hospital of Yunnan University
🇨🇳Kunming, Yunnan, China
MHAT Sveti Nikolay Chudotvorets EOOD
🇧🇬Lom, Bulgaria
UMHAT - Sveti Georgi EAD
🇧🇬Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment - KANEV
🇧🇬Ruse, Bulgaria
Medical Institute Ministry of Interior Central Clinical Base
🇧🇬Sofia, Bulgaria
University Multidisciplinary Hospital for Active Treatment and Emergency Medicine 'N. I. Priogov´
🇧🇬Sofia, Bulgaria
UMHAT - Prof. Stoyan Kirkovich
🇧🇬Stara Zagora, Bulgaria
Biomedica Research Group
🇨🇱Santiago, Chile
Hospital Gustavo Fricke
🇨🇱Viña Del Mar, Chile
The Second Affiliated Hospital of Shantou University Medical Center
🇨🇳Shantou, Guangdong, China
The Second Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Union Hospital Tongji Medical College Huazhong University
🇨🇳Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
Xi'an Medical University First Affiliated Hospital
🇨🇳Xi'an, Shaanxi, China
West China Hospital Sichuan University
🇨🇳Chengdu, Sichuan, China
West China Hospital
🇨🇳Chengdu, Sichuan, China
Chongqing No. 4 People's Hospital
🇨🇳Chongqing, Sichuan, China
Chu Hsien-I Memorial Hospital of Tianjin Medical University
🇨🇳Tianjing, Tianjin, China
General Hospital Slavonski Brod
🇭🇷Slavonski Brod, Croatia
Clinical Hospital Merkur
🇭🇷Zagreb, Croatia
Ida-Viru Central Hospital
🇪🇪Kohtla-Järve, Estonia
Tartu University Hospital
🇪🇪Tartu, Estonia
South-Estonian Hospital Ltd.
🇪🇪Võru, Estonia
LTD High Technology Hospital Med Center
🇬🇪Batumi, Georgia
JSC Vian - West Georgia Medical Center
🇬🇪Kutaisi, Georgia
Healthycore
🇬🇪Tbilisi, Georgia
Tbilisi Heart Center
🇬🇪Tbilisi, Georgia
Daugavpils Regional Hospital
🇱🇻Daugavpils, Latvia
Riga East Clinical University Hospital
🇱🇻Riga, Latvia
Clinical Hospital Center Zvezdara
🇷🇸Belgrade, Serbia
Institute of Cardiovascular Diseases Dedinje
🇷🇸Belgrade, Serbia
Univerzitna Nemocnica Bratislava
🇸🇰Bratislava, Slovakia
Fakultna Nemocnica Trnava
🇸🇰Trnava, Slovakia
Hospital Universitario Donostia
🇪🇸San Sebastián, Gipuzkoa, Spain
Hospital del Mar
🇪🇸Barcelona, Spain