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New antibiotic could fight tough diabetic foot infections

NCT ID NCT05369052

Disease control Sponsor: MicuRx Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This Phase 3 trial tests a new antibiotic called contezolid against a standard one (linezolid) for moderate to severe diabetic foot infections. About 865 adults with diabetes and a foot infection will receive either drug for 2 to 4 weeks. The goal is to see if the new drug works as well or better and has fewer side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
contezolid acefosamil (IV) and contezolid (oral)
What this could lead to
If successful, this could provide a new antibiotic option for treating serious diabetic foot infections, potentially with fewer side effects than current treatments.
What could go wrong
This is an early Phase 3 trial, so results are not yet proven. The new drug may not be more effective or safer than the existing antibiotic linezolid.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 865 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic foot infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    14 sites in 8 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Daugavpils Regional Hospital

    RECRUITING

    Daugavpils, Latvia

  • GMV Care& Research - Maria Cecilia Hospital

    RECRUITING

    Cotignola, Italy

  • ILD Research Center

    RECRUITING

    Vista, California, 92081, United States

  • Instytut Medycyny Wsi im. W. Chodzki

    RECRUITING

    Lublin, Poland

  • JSC Vian - West Georgia Medical Center

    RECRUITING

    Kutaisi, Georgia

  • LTD High Technology Hospital Med Center

    RECRUITING

    Batumi, Georgia

  • MHAT Sveti Nikolay Chudotvorets EOOD

    RECRUITING

    Lom, Bulgaria

  • Medical Institute Ministry of Interior Central Clinical Base

    RECRUITING

    Sofia, Bulgaria

  • Multiprofile Hospital for Active Treatment - KANEV

    RECRUITING

    Rousse, Bulgaria

  • New Hope Research Development

    RECRUITING

    Corona, California, 92882, United States

  • PODEMA Sp. z o.o.

    RECRUITING

    Warsaw, Poland

  • South-Estonian Hospital Ltd.

    RECRUITING

    Võru, Estonia

  • University Clinical Center Kragujevac

    RECRUITING

    Kragujevac, Serbia

  • University Multidisciplinary Hospital for Active Treatment and Emergency Medicine 'N. I. Priogov´

    RECRUITING

    Sofia, Bulgaria

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