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)

Diabetic Foot Infection Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05369052
• Other study ID #: MRXC-302
• Status: Recruiting
• Phase: Phase 3
• Start date: May 3, 2022
• Est. completion date: June 2024

Study information

• Verified date: May 2023
• Source: MicuRx
• Contact: Clinical coordinator
• Phone: 510-782-2022
• Email: info[@]micurx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 865
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Diabetic Foot
• Diabetic Foot Infection
• Infections

Intervention

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

Locations

Country	Name	City	State
Bulgaria	MHAT Blagoevgrad AD, Department of Surgery	Blagoevgrad
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	UMHAT - Sofiamed	Sofia
Bulgaria	UMHAT - Prof. Stoyan Kirkovich	Stara Zagora
China	West China Hospital	Chengdu	Sichuan
China	Chongqing No. 4 People's Hospital	Chongqing	Sichuan
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Sichuan
China	Hainan Medical College No. 2 Affiliated Hospital	Haikou	Hainan
China	Affiliated Hospital of Yunnan University	Kunming	Yunnan
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	The Second Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	The Second Affiliated Hospital of Shantou University Medical Center	Shantou	Guangdong
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Chu Hsien-I Memorial Hospital of Tianjin Medical University	Tianjing	Tianjin
China	The Central Hospital of Wuhan	Wuhan	Hubei
China	Union Hospital Tongji Medical College Huazhong University	Wuhan	Hubei
China	Xi'an Medical University First Affiliated Hospital	Xi'an	Shaanxi
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
Estonia	Ida-Viru Central Hospital	Kohtla-Järve
Estonia	Tartu University Hospital	Tartu
Estonia	Viljandi Hospital	Viljandi
Estonia	South-Estonian Hospital Ltd.	Võru
Greece	General Hospital of Athens-Laiko	Athens
Italy	AORN - Ospedali dei Colli - Ospedale D. Contugno	Napoli
Latvia	Daugavpils Regional Hospital	Daugavpils
Latvia	Riga East Clinical University Hospital	Riga
Lithuania	Hospital of Lithuanian University of Health Sciences	Kaunas
Lithuania	Vilnius University Hospital Santaros Klimkos	Vilnius
Portugal	Hospital de CUF Descobertas Lisboa	Lisboa
Puerto Rico	Clinical Research Management Group, Inc.	Mayagüez
Spain	Hospital del Mar	Barcelona
United States	Billings Clinic Research	Billings	Montana
United States	Velocity Clinical Research	Chula Vista	California
United States	New Hope Research Development	Corona	California
United States	Sacramento VA Medical Center	Mather	California
United States	University Medical and Research Center, LLC	Miami	Florida
United States	Floridian Clinical Research, LLC	Miami Lakes	Florida
United States	Perseverance Research Center. LLC	Scottsdale	Arizona
United States	South Jersey Infectious Disease	Somers Point	New Jersey
United States	Harbor-UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
MicuRx

Countries where clinical trial is conducted

United States,  Bulgaria,  China,  Estonia,  Greece,  Italy,  Latvia,  Lithuania,  Portugal,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 35
Primary	Adverse events - symptoms reported by subjects	Evaluate safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)	28-35 days after End-of-Therapy (EOT)
Primary	Clinical laboratory assessment - complete blood count	Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)	28-35 days after End-of-Therapy (EOT)
Primary	Vital signs - heart rate	Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)	28-35 days after End-of-Therapy (EOT)
Secondary	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	14-28 days
Secondary	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	Day 10, 28-35 days after EOT