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Oxazolidinone Antibiotic

New Antibiotics vs Linezolid for Diabetic Foot Infections

Phase 3
Recruiting
Research Sponsored by MicuRx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Foot infection that meets the IWGDF DFI criteria for classification 3 (moderate infection) or 4 (severe infection)
Have diabetes mellitus (type 1 or 2) per the American Diabetes Association criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28-35 days after end-of-therapy (eot)
Awards & highlights

Study Summary

This trial is comparing the safety and effectiveness of two different drugs to treat a serious bacterial infection.

Who is the study for?
Adults with moderate or severe diabetic foot infections who have diabetes mellitus (type 1 or 2), an infection that meets specific criteria, and a recent onset of symptoms can join. Those with significant organ diseases, previous resistant infections, suspected bone infections, pregnant/breastfeeding women, noncompliance risk, or certain severe conditions are excluded.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of two antibiotics: contezolid acefosamil/contezolid versus linezolid for treating diabetic foot infections. Participants will receive treatment intravenously and orally for 14 to 28 days in a randomized double-blind setup.See study design
What are the potential side effects?
Potential side effects may include issues related to digestion like nausea or diarrhea; blood disorders such as anemia; nerve problems which could cause tingling sensations; headaches; changes in taste perception; and possible liver enzyme elevations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My foot infection is classified as moderate or severe.
Select...
I have been diagnosed with diabetes (type 1 or 2).
Select...
My foot infection started or got worse in the last 2 weeks.
Select...
My foot infection is below the knee and started at or below the ankle.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 10, 28-35 days after eot
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 10, 28-35 days after eot for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events - symptoms reported by subjects
Clinical laboratory assessment - complete blood count
Vital signs - heart rate
Secondary outcome measures
Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators

Side effects data

From 2010 Phase 4 trial • 1225 Patients • NCT00084266
10%
Diarrhoea
7%
Hypokalaemia
6%
Constipation
5%
Hypertension
5%
Anaemia
5%
Urinary tract infection
4%
Hypotension
4%
Pyrexia
4%
Nausea
4%
Hypoglycaemia
4%
Rash
3%
Respiratory failure
3%
Hypomagnesaemia
3%
Decubitus ulcer
2%
Fluid overload
2%
Insomnia
2%
Pneumonia
2%
Atrial fibrillation
2%
Bradycardia
2%
Tachycardia
2%
Vomiting
2%
Oedema peripheral
2%
Pain
2%
Cardiac arrest
2%
Hyperglycaemia
2%
Hypocalcaemia
2%
Hyponatraemia
2%
Hypophosphataemia
2%
Anxiety
2%
Depression
2%
Sepsis
2%
Septic shock
2%
Cardio-respiratory arrest
2%
Agitation
2%
Generalised oedema
1%
Headache
1%
Malnutrition
1%
Hypovolaemia
1%
Urinary tract infection fungal
1%
Abdominal discomfort
1%
Abdominal distension
1%
Abdominal pain
1%
Post procedural haemorrhage
1%
Hepatic enzyme increased
1%
Liver function test abnormal
1%
Dehydration
1%
Metabolic alkalosis
1%
Somnolence
1%
Restlessness
1%
Renal impairment
1%
Multi-organ failure
1%
Brain oedema
1%
Renal failure acute
1%
Acute respiratory distress syndrome
1%
Hypoxia
1%
Pleural effusion
1%
Pulmonary embolism
1%
Respiratory distress
1%
Thrombocytopenia
1%
Arrhythmia
1%
Cardiac failure congestive
1%
Supraventricular tachycardia
1%
Ventricular tachycardia
1%
Adrenal insufficiency
1%
Dyspepsia
1%
Dysphagia
1%
Ileus
1%
Ileus paralytic
1%
Bacteraemia
1%
Candidiasis
1%
Cellulitis
1%
Clostridium difficile colitis
1%
Device related infection
1%
Fungal infection
1%
Fungal skin infection
1%
Oral candidiasis
1%
Pneumonia bacterial
1%
Excoriation
1%
Procedural pain
1%
Skin laceration
1%
Alanine aminotransferase increased
1%
Aspartate aminotransferase increased
1%
Blood bilirubin increased
1%
Blood lactate dehydrogenase increased
1%
Blood pressure increased
1%
Fungal test positive
1%
Transaminases increased
1%
Hypernatraemia
1%
Hypoalbuminaemia
1%
Metabolic acidosis
1%
Pain in extremity
1%
Confusional state
1%
Haematuria
1%
Atelectasis
1%
Bronchospasm
1%
Oropharyngeal pain
1%
Tachypnoea
1%
Erythema
1%
Skin disorder
1%
Haemorrhagic anaemia
1%
Angina pectoris
1%
Pancreatitis
1%
Infusion site phlebitis
1%
Postoperative wound infection
1%
Hyperkalaemia
1%
Urinary retention
1%
Pulmonary oedema
1%
Pruritus
1%
Skin ulcer
1%
Device occlusion
1%
Oedema
1%
Contusion
1%
Platelet count increased
1%
Convulsion
1%
Disorientation
1%
Oliguria
1%
Myocardial infarction
1%
Lung infection
1%
Lung infection pseudomonal
1%
Urinary tract infection pseudomonal
1%
Delirium
1%
Haemoptysis
1%
Hiccups
1%
Laryngeal oedema
1%
Dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Linezolid
Vancomycin

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: contezolid acefosamil/contezolidExperimental Treatment1 Intervention
Group II: linezolidActive Control1 Intervention

Find a Location

Who is running the clinical trial?

MicuRxLead Sponsor
5 Previous Clinical Trials
597 Total Patients Enrolled

Media Library

Contezolid Acefosamil/Contezolid (Oxazolidinone Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05369052 — Phase 3
Diabetic Foot Infection Research Study Groups: contezolid acefosamil/contezolid, linezolid
Diabetic Foot Infection Clinical Trial 2023: Contezolid Acefosamil/Contezolid Highlights & Side Effects. Trial Name: NCT05369052 — Phase 3
Contezolid Acefosamil/Contezolid (Oxazolidinone Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05369052 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a high risk of negative side effects from taking contezolid acefosamil (IV)/contezolid (PO)?

"Contezolid acefosamil (IV)/contezolid (PO) has some efficacy data from Phase 3 trials and multiple rounds of safety data, so it received a score of 3."

Answered by AI

Are there any available openings for willing test subjects?

"Yes, this clinical trial is still open and accepting patients. According to the information available on clinicaltrials.gov, the study was first posted on May 1st, 2022 and last updated on May 5th, 2022. They are looking for 865 between 1 locations."

Answered by AI

How many individuals can enroll in this research project?

"That is correct. The clinicaltrials.gov website has the latest information on this study, which is looking for 865 participants at 1 site. The trial was first posted on 5/1/2022 and edited on 5/5/2022."

Answered by AI
~72 spots leftby Jun 2024