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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: contezolid acefosamil (IV)/contezolid (PO), Linezolid (IV and PO).
- Who it may be relevant to
- Registry conditions: Diabetic Foot Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Bulgaria, Estonia, Georgia, Italy +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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.
Detailed 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).
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)
Primary outcome measures
- Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators [Time frame: Day 35]
- Adverse events - symptoms reported by subjects [Time frame: 28-35 days after End-of-Therapy (EOT)]
- Clinical laboratory assessment - complete blood count [Time frame: 28-35 days after End-of-Therapy (EOT)]
- Vital signs - heart rate [Time frame: 28-35 days after End-of-Therapy (EOT)]
Secondary outcome measures (2)
- Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators [Time frame: 14-28 days]
- Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators [Time frame: Day 10, 28-35 days after EOT]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Bulgaria · 4 centers
- MHAT Sveti Nikolay Chudotvorets EOOD — Lom
- Multiprofile Hospital for Active Treatment - KANEV — Rousse
- Medical Institute Ministry of Interior Central Clinical Base — Sofia
- University Multidisciplinary Hospital for Active Treatment and Emergency Medicine 'N. I. P — Sofia
United States · 2 centers
- New Hope Research Development — Corona
- ILD Research Center — Vista
Georgia · 2 centers
- LTD High Technology Hospital Med Center — Batumi
- JSC Vian - West Georgia Medical Center — Kutaisi
Poland · 2 centers
- Instytut Medycyny Wsi im. W. Chodzki — Lublin
- PODEMA Sp. z o.o. — Warsaw
Estonia · 1 center
- South-Estonian Hospital Ltd. — Võru
Italy · 1 center
- GMV Care& Research - Maria Cecilia Hospital — Cotignola
Latvia · 1 center
- Daugavpils Regional Hospital — Daugavpils
Serbia · 1 center
- University Clinical Center Kragujevac — Kragujevac
Identifiers
NCT: NCT05369052 · MRXC-302