Diabetic Foot Infection
Conditions
Brief 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.
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
DRUGcontezolid 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) administered for a total of 14 to 28 days (28 to 56 doses)
Sponsors
MicuRx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators | 14-28 days | Evaluate the Investigator's assessment of clinical response at EOT visit in the MITT analysis set |
Countries
Bulgaria, Estonia, Georgia, Italy, Latvia, Poland, Serbia, United States
Contacts
Primary ContactClinical coordinator
Outcome results
None listed