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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)

NCT05369052 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 865

Last updated 2025-09-10

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Infection

Interventions

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)

Sponsors & Collaborators

  • MicuRx

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-03
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Estonia
  • Georgia
  • Italy
  • Latvia
  • Poland
  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05369052 on ClinicalTrials.gov