Back to resultsSafety 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)
Primary Purpose
Diabetic Foot Infection
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
contezolid acefosamil (IV)/contezolid (PO)
Linezolid (IV and PO)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Infection
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
Sites / Locations
- Perseverance Research Center. LLCRecruiting
- Velocity Clinical ResearchRecruiting
- New Hope Research DevelopmentRecruiting
- Harbor-UCLA Medical CenterRecruiting
- University Medical and Research Center, LLCRecruiting
- Floridian Clinical Research, LLCRecruiting
- Regional Infectious Diseases and Infusion Center, Inc.Recruiting
- Billings Clinic ResearchRecruiting
- South Jersey Infectious DiseaseRecruiting
- Houston Foot and Ankle CareRecruiting
- MHAT Blagoevgrad AD, Department of SurgeryRecruiting
- UMHAT - Sveti Georgi EADRecruiting
- Multiprofile Hospital for Active Treatment - KANEVRecruiting
- Medical Institute Ministry of Interior Central Clinical BaseRecruiting
- UMHAT - SofiamedRecruiting
- UMHAT - Prof. Stoyan KirkovichRecruiting
- The Second Affiliated Hospital of Shantou University Medical CenterRecruiting
- The Second Affiliated Hospital of Guangxi Medical UniversityRecruiting
- Hainan Medical College No. 2 Affiliated HospitalRecruiting
- The First Hospital of Hebei Medical UniversityRecruiting
- The Central Hospital of WuhanRecruiting
- Union Hospital Tongji Medical College Huazhong UniversityRecruiting
- Zhongda Hospital Southeast UniversityRecruiting
- Affiliated Hospital of Jiangsu UniversityRecruiting
- Xi'an Medical University First Affiliated HospitalRecruiting
- West China HospitalRecruiting
- Chongqing No. 4 People's HospitalRecruiting
- The Second Affiliated Hospital of Chongqing Medical UniversityRecruiting
- Chu Hsien-I Memorial Hospital of Tianjin Medical UniversityRecruiting
- Affiliated Hospital of Yunnan UniversityRecruiting
- Ida-Viru Central HospitalRecruiting
- Tartu University HospitalRecruiting
- Viljandi HospitalRecruiting
- South-Estonian Hospital Ltd.Recruiting
- CH TourcoingRecruiting
- General Hospital of Athens-LaikoRecruiting
- ASST Fatebenefratelli Sacco-Ospedale Luigi Sacco - Polo UniversitarioRecruiting
- AORN - Ospedali dei Colli - Ospedale D. ContugnoRecruiting
- Daugavpils Regional HospitalRecruiting
- Riga East Clinical University HospitalRecruiting
- Hospital of Lithuanian University of Health SciencesRecruiting
- Klaipeda University HospitalRecruiting
- Vilnius University Hospital Santaros KlimkosRecruiting
- Hospital de CUF Descobertas LisboaRecruiting
- Clinical Research Management Group, Inc.Recruiting
- Hospital del MarRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
contezolid acefosamil/contezolid
linezolid
Arm Description
Outcomes
Primary Outcome Measures
Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators
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
Adverse events - symptoms reported by subjects
Evaluate safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)
Clinical laboratory assessment - complete blood count
Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)
Vital signs - heart rate
Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)
Secondary Outcome Measures
Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators
Evaluate the Investigator's assessment of clinical response at EOT visit in the MITT analysis set
Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05369052
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MicuRx
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
865 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
contezolid acefosamil/contezolid
Arm Type
Experimental
Arm Title
linezolid
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
contezolid acefosamil (IV)/contezolid (PO)
Intervention Description
Contezolid acefosamil (IV)/contezolid (PO) administered for a total of 14 to 28 days (28 to 56 doses)
Intervention Type
Drug
Intervention Name(s)
Linezolid (IV and PO)
Intervention Description
Linezolid (IV and PO) administered for a total of 14 to 28 days (28 to 56 doses)
Primary Outcome Measure Information:
Title
Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators
Description
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
Time Frame
Day 35
Title
Adverse events - symptoms reported by subjects
Description
Evaluate safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)
Time Frame
28-35 days after End-of-Therapy (EOT)
Title
Clinical laboratory assessment - complete blood count
Description
Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)
Time Frame
28-35 days after End-of-Therapy (EOT)
Title
Vital signs - heart rate
Description
Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)
Time Frame
28-35 days after End-of-Therapy (EOT)
Secondary Outcome Measure Information:
Title
Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators
Description
Evaluate the Investigator's assessment of clinical response at EOT visit in the MITT analysis set
Time Frame
14-28 days
Title
Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators
Description
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
Time Frame
Day 10, 28-35 days after EOT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical coordinator
Phone
510-782-2022
Email
info@micurx.com
Facility Information:
Facility Name
Perseverance Research Center. LLC
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Individual Site Status
Recruiting
Facility Name
New Hope Research Development
City
Corona
State/Province
California
ZIP/Postal Code
92882
Country
United States
Individual Site Status
Recruiting
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Individual Site Status
Recruiting
Facility Name
University Medical and Research Center, LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Name
Floridian Clinical Research, LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Name
Regional Infectious Diseases and Infusion Center, Inc.
City
LaGrange
State/Province
Georgia
ZIP/Postal Code
30240
Country
United States
Individual Site Status
Recruiting
Facility Name
Billings Clinic Research
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Individual Site Status
Recruiting
Facility Name
South Jersey Infectious Disease
City
Somers Point
State/Province
New Jersey
ZIP/Postal Code
08244
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Foot and Ankle Care
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Individual Site Status
Recruiting
Facility Name
MHAT Blagoevgrad AD, Department of Surgery
City
Blagoevgrad
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT - Sveti Georgi EAD
City
Plovdiv
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital for Active Treatment - KANEV
City
Ruse
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Institute Ministry of Interior Central Clinical Base
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT - Sofiamed
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT - Prof. Stoyan Kirkovich
City
Stara Zagora
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Shantou University Medical Center
City
Shantou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Name
Hainan Medical College No. 2 Affiliated Hospital
City
Haikou
State/Province
Hainan
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Name
The Central Hospital of Wuhan
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
Union Hospital Tongji Medical College Huazhong University
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
Xi'an Medical University First Affiliated Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710077
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Name
Chongqing No. 4 People's Hospital
City
Chongqing
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Name
Chu Hsien-I Memorial Hospital of Tianjin Medical University
City
Tianjing
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Yunnan University
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Name
Ida-Viru Central Hospital
City
Kohtla-Järve
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Tartu University Hospital
City
Tartu
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Viljandi Hospital
City
Viljandi
Country
Estonia
Individual Site Status
Recruiting
Facility Name
South-Estonian Hospital Ltd.
City
Võru
Country
Estonia
Individual Site Status
Recruiting
Facility Name
CH Tourcoing
City
Tourcoing
Country
France
Individual Site Status
Recruiting
Facility Name
General Hospital of Athens-Laiko
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Name
ASST Fatebenefratelli Sacco-Ospedale Luigi Sacco - Polo Universitario
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Name
AORN - Ospedali dei Colli - Ospedale D. Contugno
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Name
Daugavpils Regional Hospital
City
Daugavpils
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Riga East Clinical University Hospital
City
Riga
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Hospital of Lithuanian University of Health Sciences
City
Kaunas
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Klaipeda University Hospital
City
Klaipėda
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Vilnius University Hospital Santaros Klimkos
City
Vilnius
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Hospital de CUF Descobertas Lisboa
City
Lisboa
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Clinical Research Management Group, Inc.
City
Ponce
ZIP/Postal Code
00780
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
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)
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