Last updated 59 days ago

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)

865 patients around the world

Available in Brazil, Argentina

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).

MicuRx

7Research sites

865Patients around the world

This study is for people with

Diabetes

Diabetic Foot

Requirements for the patient

From 18 Years

All Gender

Medical requirements

: 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.

: 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.

Sites

Fundación Sanatorio Güemes - CABA, Buenos Aires

Recruiting

Fco Acuña de Figueroa 1228

Clínica Privada Chutro SRL - Córdoba

Recruiting

Av. Colon 788, Córdoba

Nuevo Hospital San Roque - Córdoba

Recruiting

Bajada Pucara 1900, Córdoba

Instituto Médico Platense SA - La Plata

Recruiting

Boulevard 51 Nro 315, La Plata, Buenos Aires

Centro de Investigaciones Médicas Mar del Plata SRL

Recruiting

Av. Colón 3083, Mar del Plata, Buenos Aires

Hospital Ernesto Dornelles

Recruiting

Av. Ipiranga, 1801 - Azenha, Porto Alegre - RS, 90160-092

CPClin – Centro de Pesquisas Clinicas LTDA

Recruiting

Avenida Angélica, 2162 – Consolação – São Paulo, SP, CEP:01228-200

SponsorMicuRx

Conditions

Diabetic Foot

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05369052