Diabetic Foot InfectionPhase 3NCT05369052
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)
A Phase 3 study testing contezolid acefosamil (IV)/contezolid (PO) and Linezolid (IV and PO) in people with Diabetic Foot Infection, run by MicuRx at 14 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Infection
- What is being tested?
- contezolid acefosamil (IV)/contezolid (PO) and Linezolid (IV and PO)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 865 participants
- Where
- 14 sitesin 8 countries
- Study dates
- 3 May 2022to 30 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 8 countries
Bulgaria4 sites, 4 recruiting
- Recruiting
MHAT Sveti Nikolay Chudotvorets EOOD
Lom
- Recruiting
Multiprofile Hospital for Active Treatment - KANEV
Rousse
- Recruiting
Medical Institute Ministry of Interior Central Clinical Base
Sofia
- Recruiting
University Multidisciplinary Hospital for Active Treatment and Emergency Medicine 'N. I. Priogov´
Sofia
United States2 sites, 2 recruiting
- Recruiting
New Hope Research Development
Corona, California, 92882
- Recruiting
ILD Research Center
Vista, California, 92081
Georgia2 sites, 2 recruiting
- Recruiting
LTD High Technology Hospital Med Center
Batumi
- Recruiting
JSC Vian - West Georgia Medical Center
Kutaisi
Poland2 sites, 2 recruiting
- Recruiting
Instytut Medycyny Wsi im. W. Chodzki
Lublin
- Recruiting
PODEMA Sp. z o.o.
Warsaw
Italy1 site, 1 recruiting
- Recruiting
GMV Care& Research - Maria Cecilia Hospital
Cotignola
Serbia1 site, 1 recruiting
- Recruiting
University Clinical Center Kragujevac
Kragujevac
About this study
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)
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.
Read the 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).
- Conditions
- Diabetic Foot Infection
- Being tested
- contezolid acefosamil (IV)/contezolid (PO), Linezolid (IV and PO)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| contezolid acefosamil/contezolid | Experimental | Not described Receives: Drug: contezolid acefosamil (IV)/contezolid (PO) |
| linezolid | Active comparator | Not described Receives: Drug: Linezolid (IV and PO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 35
Adverse events - symptoms reported by subjects
Evaluate safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)
Measured: 28-35 days after End-of-Therapy (EOT)
Clinical laboratory assessment - complete blood count
Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)
Measured: 28-35 days after End-of-Therapy (EOT)
Vital signs - heart rate
Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO)
Measured: 28-35 days after End-of-Therapy (EOT)
Secondary outcomes (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 EOT visit in the MITT analysis set
Measured: 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
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
Measured: Day 10, 28-35 days after EOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start3 May 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 865 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MicuRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369052
- Sponsor's protocol ID
- MRXC-302
- Status last verified
- Oct 2026
- First submitted
- 12 Apr 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05369052
- Acronym / sponsor ID
- MRXC-302
- Conditions
- Diabetic Foot Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 865 participants (estimated)
- Lead sponsor
- MicuRxIndustry (pharma, biotech, devices)
- Study start
- 3 May 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| contezolid acefosamil/contezolid | Experimental | Drug: contezolid acefosamil (IV)/contezolid (PO) |
| linezolid | Active comparator | Drug: Linezolid (IV and PO) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| contezolid acefosamil (IV)/contezolid (PO)Contezolid acefosamil (IV)/contezolid (PO) administered for a total of 14 to 28 days (28 to 56 doses) | Drug | contezolid acefosamil/contezolid |
| Linezolid (IV and PO)Linezolid (IV and PO) administered for a total of 14 to 28 days (28 to 56 doses) | Drug | linezolid |
Primary outcome
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
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
Time frame: 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
Time frame: 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
Time frame: 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)
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing contezolid acefosamil (IV)/contezolid (PO) and Linezolid (IV and PO) in people with Diabetic Foot Infection, run by MicuRx at 14 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Bulgaria, United States, Georgia, Poland, Estonia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical coordinator (510-782-2022, info@micurx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.