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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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy

Other Sites

Site Name City Country Status
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
General University Hospital Of Larissa Larissa Greece
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
KBC Zagreb Zagreb Croatia
Centre Hospitalier De Tourcoing Tourcoing France
University Of Debrecen Debrecen Hungary
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
General Hospital Dr. Josip Bencevic Slavonski Brod Croatia
Centre Hospitalier Universitaire d’Orléans Orléans France
Hospital Clinic De Barcelona Barcelona Spain
Semmelweis University Budapest Hungary
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Markhot Ferenc Oktatokorhaz Es Rendelointezet Eger Hungary
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Multidisciplinary Hospital For Active Treatment Haskovo AD Haskovo Bulgaria
Fakultna Nemocnica S Poliklinikou Zilina Zilina Slovakia
Spitalul Clinic Judetean De Urgenta Sibiu Sibiu Romania
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Institutul National De Boli Infectioase Prof.Dr.Matei Bals Bucharest Romania
Respublikine Klaipedos ligonine VšĮ Klaipeda Lithuania
Multiprofile Hospital For Active Treatment Sveti Nikolay Chuditvorets EOOD Lom Bulgaria
Centre Hospitalier Universitaire De Nimes Nimes France
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
Hospital Del Mar Barcelona Spain
Medical Institute Ministry Of Interior Sofia Bulgaria
Fakultna Nemocnica Trnava Trnava Slovakia
Louna-Eesti Haigla AS Voru Estonia
Daugavpils regionala slimnica SIA Daugavpils Latvia
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
University Multiprofessional Hospital For Active Treatment Kanev AD Ruse Bulgaria
Multiprofile Hospital For Active Treatment Blagoevgrad AD Blagoevgrad Bulgaria
Army Hospital General L. Svoboda Svidnik a.s. Svidnik Slovakia
University Of Szeged Szeged Hungary
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD Sofia Bulgaria
University Hospital Merkur Zagreb Croatia
Hfymesjd Ujuodtlmxztha Dfxqqwag Donostia / San Sebastian Spain
Iycbcffbe Fzv Cfbuhrix Apl Eyakfhhetfhk Mssvvfmg Prague Czechia
Iqfdeagvj Da Izxscgzhwosbd Ej Cmcbxfsh Db Lj Sqdvx Gwnwhkh Tgxwa I Pnclm Barcelona Spain
Mdsvr Mydiiulm Kvndun suqgfv Ostrava Czechia
Mbioh Crpxuzh Hankckum Sxsxxr Cotignola Italy
Skzppk Cdtrlxct Rbzypcst Snlyaz Brasov Romania
Plbomvzt Suyxvktk Suyptz Bucharest Romania
Pxjtrpwxk Sbdkqd Cluj Napoca Romania
Bnhuz kqbttuf Uow Kaunas Lithuania
Vjypbisp mjisjt kwzxqtgfc lnvgclbu Vmkfv Vilnius Lithuania
Isbgunvn Mvuxtiat Wio Ipi Wxlkdpx Clpuymo Lublin Poland
Lhilj Gptcycj Heylfmuv Of Amysjq Athens Greece
Ucpgawjakd Heghcjqz Bektebxawt Bratislava Slovakia
Skizwjwz Ccxemv &ajzajvyyc Iz Cwflgcdmwivigzykoh Bucharest Romania
Fwpvndij nepmkvcvd Msbud a Hmwbokp Prague Czechia
Pskfq Kfpmvae Lhxcnbla Rhh Warsaw Poland
Pgncnxe Sbtsgd Upwxr Kaniby Rvnqckaytytkhc Budapest Hungary
Hmvaeabi Du Lg Stbiu Cxdu I Svty Pox Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
06.12.2022
Croatia Croatia
Not recruiting
06.12.2022
Czechia Czechia
Not recruiting
06.12.2022
Estonia Estonia
Recruiting
06.12.2022
France France
Not recruiting
06.12.2022
Greece Greece
Not recruiting
06.12.2022
Hungary Hungary
Not recruiting
06.12.2022
Italy Italy
Recruiting
06.12.2022
Latvia Latvia
Recruiting
06.12.2022
Lithuania Lithuania
Not recruiting
06.12.2022
Poland Poland
Recruiting
06.12.2022
Portugal Portugal
Not recruiting
06.12.2022
Romania Romania
Not recruiting
06.12.2022
Slovakia Slovakia
Not recruiting
06.12.2022
Spain Spain
Not recruiting
06.12.2022

Trial locations

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.

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 ID:
2022-500257-16-00
Protocol code:
MRXC-302
NCT ID:
NCT05369052
Trial Phase:
Therapeutic confirmatory (Phase III)

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