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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)

ConditionDiabetic Foot Infection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMicuRx

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • contezolid acefosamil (IV)/contezolid (PO)

    Drug

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

  • Linezolid (IV and PO)

    Drug

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

Treatment groups

865 Participants
are divided into 2 treatment groups
Group A: contezolid acefosamil/contezolidExperimental treatment 1 intervention
Group B: linezolidActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators

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

Time frame
Day 35
2

Adverse events - symptoms reported by subjects

Evaluate safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)

Time frame
28-35 days after End-of-Therapy (EOT)
3

Clinical laboratory assessment - complete blood count

Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)

Time frame
28-35 days after End-of-Therapy (EOT)
4

Vital signs - heart rate

Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)

Time frame
28-35 days after End-of-Therapy (EOT)

Secondary outcomes

1

Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators

Evaluate the Investigator's assessment of clinical response at EOT visit in the MITT analysis set

Time frame
14-28 days
2

Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators

Evaluate the Investigator's assessment of clinical response at Day 10 (D10) and Late Follow-Up visits (LFU; 28-35 days after EOT) in the MITT analysis set

Time frame
Day 10, 28-35 days after EOT

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MicuRx

Lead sponsor

Source ClinicalTrials.gov
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