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Study on the Safety and Effectiveness of Contezolid Acefosamil, Contezolid, and Linezolid for Adults with Moderate or Severe Diabetic Foot Infections

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Diabetic Foot Infections, which are infections that occur in the feet of people with diabetes. The study will compare the effectiveness and safety of two medications, Contezolid Acefosamil and Contezolid, with another medication called Linezolid. These medications will be given to participants either through an intravenous infusion, which means the medicine is delivered directly into the bloodstream, or orally, which means the medicine is taken by mouth in tablet form.

The purpose of the study is to evaluate how well these medications work in treating moderate or severe diabetic foot infections. Participants will be randomly assigned to receive either the new medications, Contezolid Acefosamil and Contezolid, or the existing medication, Linezolid. Some participants may receive a placebo, which looks like the real medication but does not contain any active ingredients. The study will last for a period of up to 28 days, during which the participants' health and response to the treatment will be closely monitored by the study team.

Throughout the study, the safety and tolerability of the medications will be assessed, meaning the researchers will check for any side effects or adverse reactions. The main goal is to see if the new medications are as effective or more effective than Linezolid in treating the infections. Participants will have regular check-ups and assessments to track their progress and the effectiveness of the treatment. The study aims to provide valuable information that could lead to improved treatment options for people with diabetic foot infections.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to receive either contezolid acefosamil or linezolid. This process is double-blind, meaning neither you nor the study team will know which medication you are receiving.

  2. Step 2

    Initial treatment phase

    You will begin treatment with the assigned medication. If you are receiving contezolid acefosamil, it will be administered through an intravenous infusion. If you are receiving linezolid, it will be administered either intravenously or orally, depending on your specific treatment plan.

  3. Step 3

    Oral medication phase

    After the initial treatment phase, you may transition to oral medication. If you are on contezolid, you will take it in tablet form. If you are on linezolid, you will continue with oral tablets.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, your health and response to the medication will be closely monitored. You will have regular visits with the study team to assess your progress and any side effects you may experience.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment period, you will have a final evaluation to assess the effectiveness of the medication and your overall health. This will include a clinical response assessment at the day 35 visit.

Who can join the trial?

9 criteria

  • Must be a male or female who is at least 18 years old.
  • Must be willing and able to provide written consent to participate in the study.
  • Must have diabetes mellitus (type 1 or type 2), which is a condition where the body has trouble managing blood sugar levels.
  • Must have a foot infection that started at or below the ankle and does not go above the knee.
  • The foot infection must be classified as moderate or severe and is suspected to be caused by a specific type of bacteria known as Gram-positive bacteria.
  • The foot infection must have started or gotten worse within the last 14 days.
  • Must have received less than 48 hours of an antibiotic that could effectively treat the current infection within 96 hours before starting the study medication.
  • Females must be either postmenopausal (no menstrual periods for at least 2 years), surgically sterile, or if they can have children, must have a negative pregnancy test and agree to use a highly effective method of birth control during the study.
  • Males who are not sterile and are sexually active with female partners who can have children must agree to use effective birth control methods during the study and for 60 days after the study. They must also not donate sperm during this time.

Who cannot join the trial?

10 criteria

  • Patients with any other serious infections that are not related to diabetic foot infections.
  • Patients who have had an allergic reaction to similar medications in the past.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of severe liver or kidney disease.
  • Patients who are pregnant or breastfeeding.
  • Patients with a compromised immune system, which means their body has a reduced ability to fight infections.
  • Patients who have used certain antibiotics recently that might interfere with the study medication.
  • Patients with a history of alcohol or drug abuse.
  • Patients who have a condition that might affect the absorption of oral medications.
  • Patients who have a mental health condition that might affect their ability to follow study instructions.
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Investigated drugs

  • Contezolid Acefosamil

    is a medication being tested in this clinical trial. It is given to patients through an intravenous (IV) drip, which means it is delivered directly into the bloodstream through a vein. This medication is being studied to see how well it works in treating infections in the feet of people with diabetes. The goal is to find out if it can help clear up these infections and how safe it is for patients to use.

  • Contezolid

    is another form of the medication being tested in this trial. Unlike Contezolid Acefosamil, this one is taken by mouth in the form of a pill. It is also being studied for its effectiveness in treating diabetic foot infections. Researchers want to know if it can help improve the condition of the infection and if it is safe for patients to take.

  • Linezolid

    is a medication that is already used to treat various bacterial infections, including those in the skin and soft tissues. In this trial, it is used as a comparison to the new medications, Contezolid Acefosamil and Contezolid. Linezolid can be given both intravenously and orally, and the study aims to compare its effectiveness and safety with the new treatments for diabetic foot infections.

What is already known about the treatment

  • Contezolid Acefosamil

    Contezolid Acefosamil is administered intravenously, meaning it is given directly into a vein, and is currently being studied in clinical trials for its effectiveness and safety in treating moderate to severe diabetic foot infections. It is not yet widely used in medicine, as it is still under investigation. The medication works by targeting and inhibiting the growth of bacteria, helping to clear infections. It belongs to a class of drugs known as antibiotics, specifically designed to fight bacterial infections.

  • Contezolid

    Contezolid is taken orally, which means it is administered by mouth in the form of a pill or tablet, and is being evaluated in clinical trials for its role in treating moderate to severe diabetic foot infections. Like Contezolid Acefosamil, it is not yet fully established in medical practice as it is still being tested. Contezolid functions by stopping bacteria from growing, thereby treating the infection. It is classified as an antibiotic, a type of medication used to combat bacterial infections.

  • Linezolid

    Linezolid can be administered both intravenously and orally, allowing for flexible treatment options, and is already an established medication used to treat various bacterial infections, including diabetic foot infections. It works by preventing bacteria from producing proteins necessary for their growth, effectively stopping the infection. Linezolid is part of the antibiotic class of drugs, which are used to treat infections caused by bacteria.

Investigated diseases

Diabetic Foot Infections – Diabetic Foot Infections occur when wounds or ulcers on the feet of individuals with diabetes become infected. These infections are often caused by bacteria and can lead to redness, swelling, and warmth in the affected area. As the infection progresses, it may cause pus formation and tissue damage. If not managed, the infection can spread to deeper tissues, including muscles and bones. This can result in increased pain and difficulty in walking. The condition requires careful monitoring to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500257-16-00Protocol codeMRXC-302Estimated enrolment984 patientsSponsorMicurx Pharmaceuticals Inc.

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