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Clinical Trials in Italy / NCT05369052
Recruiting Phase 3

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 · tracked via the Priya Life Science Italy tracker
Sponsor
MicuRx
Phase
Phase 3
Started
2022-05-03
Last updated
2025-09-10

Condition(s) studied

Diabetic Foot Infection

Investigational drug(s) / intervention(s)

contezolid acefosamil (IV)/contezolid (PO)Linezolid (IV and PO) →

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

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators — Day 35
    The primary objective is to evaluate the Investigator's assessment of clinical response at the D35 visit in subjects receiving contezolid acefosamil/contezolid compared to subjects receiving linezolid in the MITT analysis
  • Adverse events - symptoms reported by subjects — 28-35 days after End-of-Therapy (EOT)
    Evaluate safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)
  • Clinical laboratory assessment - complete blood count — 28-35 days after End-of-Therapy (EOT)
    Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)
  • Vital signs - heart rate — 28-35 days after End-of-Therapy (EOT)
    Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)

Trial sites (14)

FacilityCityRegionStatus
New Hope Research Development Corona California Recruiting
ILD Research Center Vista California Recruiting
MHAT Sveti Nikolay Chudotvorets EOOD Lom Bulgaria Recruiting
Multiprofile Hospital for Active Treatment - KANEV Rousse Bulgaria Recruiting
Medical Institute Ministry of Interior Central Clinical Base Sofia Bulgaria Recruiting
University Multidisciplinary Hospital for Active Treatment and Emergency Medicine 'N. I. Priogov´ Sofia Bulgaria Recruiting
South-Estonian Hospital Ltd. Võru Estonia Recruiting
LTD High Technology Hospital Med Center Batumi Georgia Recruiting
JSC Vian - West Georgia Medical Center Kutaisi Georgia Recruiting
GMV Care& Research - Maria Cecilia Hospital Cotignola Italy Recruiting
Daugavpils Regional Hospital Daugavpils Latvia Recruiting
Instytut Medycyny Wsi im. W. Chodzki Lublin Poland Recruiting
PODEMA Sp. z o.o. Warsaw Poland Recruiting
University Clinical Center Kragujevac Kragujevac Serbia Recruiting

Other trials for the same condition

PHOTOFINISH: a Clinical Study To Evaluate The Efficacy And Safety Of the System VULNOFAST® Plus/VULNOLIGHT® In Addition To The Usual Care (UC) Vs UC Alone For The Treatment Of Infected Diabetic Foot Ulcers Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05369052 on ClinicalTrials.gov ↗ ← All trials in Italy