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)

  • STATUS
    Recruiting
  • End date
    Jun 23, 2024
  • participants needed
    865
  • sponsor
    MicuRx
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Updated on 23 September 2023
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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).

Details
Condition Diabetic Foot Infection
Treatment contezolid acefosamil (IV)/contezolid (PO), Linezolid (IV and PO)
Clinical Study IdentifierNCT05369052
SponsorMicuRx
Last Modified on23 September 2023

Eligibility

 Yes No Not Sure

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
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