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)

Phase 3

Recruiting

• Conditions: Diabetic Foot Infection
• Interventions: Drug: contezolid acefosamil (IV)/contezolid (PO); Drug: Linezolid (IV and PO)

• 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).

Study Timeline

• Study First Submitted: 2022-04-12
• Study Start: 2022-05-03
• Study First Submitted QC: 2022-05-05
• Study First Posted: 2022-05-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-06-19
• Last Update Posted: 2025-06-25
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 865

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

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 (16)

New Hope Research Development; 🇺🇸 Corona, California, United States

ILD Research Center; 🇺🇸 Vista, California, United States

Instituto Medico Platense; 🇦🇷 La Plata, Argentina

Centro de Estudos e Pesquisas Em Molestias Infecciosas Ltda CPCLIN; 🇧🇷 Rio Grande, Brazil

MHAT Sveti Nikolay Chudotvorets EOOD; 🇧🇬 Lom, 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

South-Estonian Hospital Ltd.; 🇪🇪 Võru, Estonia

LTD High Technology Hospital Med Center; 🇬🇪 Batumi, Georgia

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