NCT05369052

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)

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 865 (estimated)
• Sponsor: MicuRx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Diabetic Foot Infection

Interventions

Type	Name	Description
DRUG	contezolid acefosamil (IV)/contezolid (PO)	Contezolid acefosamil (IV)/contezolid (PO) administered for a total of 14 to 28 days (28 to 56 doses)
DRUG	Linezolid (IV and PO)	Linezolid (IV and PO) administered for a total of 14 to 28 days (28 to 56 doses)

Timeline

• Start date: 2022-05-03
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2022-05-11
• Last updated: 2025-09-10

Locations

14 sites across 8 countries: United States, Bulgaria, Estonia, Georgia, Italy, Latvia, Poland, Serbia

Regulatory

• FDA-regulated drug study