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)

MicuRx

Status and phase: Enrolling; Phase 3

Conditions: Diabetic Foot Infection

Treatments: Drug: contezolid acefosamil (IV)/contezolid (PO); Drug: Linezolid (IV and PO)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05369052

MRXC-302

Details and patient eligibility

About

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.

Full 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).

Enrollment: 865 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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865 participants in 2 patient groups

contezolid acefosamil/contezolid

Experimental group

Treatment:

Drug: contezolid acefosamil (IV)/contezolid (PO)

linezolid

Active Comparator group

Treatment:

Drug: Linezolid (IV and PO)