RecruitingPhase 3NCT05369052

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)

Sponsor

MicuRx

Enrollment

865 participants

Start Date

May 3, 2022

Study Type

INTERVENTIONAL

Conditions

Diabetic Foot Infection

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Linezolid (IV and PO) and a drug called contezolid acefosamil (IV)/contezolid (PO) for people with diabetic foot infection. The study is currently recruiting participants at 14 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGcontezolid acefosamil (IV)/contezolid (PO)

Contezolid acefosamil (IV)/contezolid (PO) administered for a total of 14 to 28 days (28 to 56 doses)

DRUGLinezolid (IV and PO)

Linezolid (IV and PO) administered for a total of 14 to 28 days (28 to 56 doses)

Locations(14)

New Hope Research Development

Corona, California, United States

ILD Research Center

Vista, California, United States

MHAT Sveti Nikolay Chudotvorets EOOD

Lom, Bulgaria

Multiprofile Hospital for Active Treatment - KANEV

Rousse, 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

JSC Vian - West Georgia Medical Center

Kutaisi, Georgia

GMV Care& Research - Maria Cecilia Hospital

Cotignola, Italy

Daugavpils Regional Hospital

Daugavpils, Latvia

Instytut Medycyny Wsi im. W. Chodzki

Lublin, Poland

PODEMA Sp. z o.o.

Warsaw, Poland

University Clinical Center Kragujevac

Kragujevac, Serbia

View Full Details on ClinicalTrials.gov

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NCT05369052

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