What side effects are associated with this type of intervention?

Common treatments for Diabetic Foot Infection that inhibit bacterial protein synthesis, such as linezolid, are known to cause gastrointestinal disturbances (nausea, diarrhea), hematologic effects (thrombocytopenia, anemia), and neuropathic effects (peripheral and optic neuropathy). Prolonged use can also lead to lactic acidosis and serotonin syndrome, particularly when used with serotonergic drugs. Contezolid acefosamil, being studied in comparison to linezolid, is expected to have a similar side effect profile.

What prior FDA approvals exist?

The FDA has approved several antibiotics for the treatment of Diabetic Foot Infections (DFI) that inhibit bacterial protein synthesis. Linezolid, an oxazolidinone antibiotic, was approved for the treatment of various bacterial infections, including DFI. Tedizolid, another oxazolidinone, was later approved as well, offering a similar mechanism of action with potentially fewer side effects. Both drugs work by inhibiting bacterial protein synthesis, making them effective against Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). These approvals provide a precedent for the potential approval of contezolid acefosamil, which operates through a similar mechanism.

What other types of research exist?

Promising novel alternatives to Contezolid acefosamil for diabetic foot infections include: <ol> <li>Delafloxacin: A fluoroquinolone antibiotic effective against a broad range of bacteria, including MRSA.</li> <li></li> </ol> Tedizolid: An oxazolidinone antibiotic similar to linezolid but with a potentially better safety profile. 3. Omadacycline: A tetracycline derivative effective against both Gram-positive and Gram-negative bacteria, including resistant strains. 4. Ceftazidime-avibactam: A combination of a third-generation cephalosporin and a beta-lactamase inhibitor, effective against multi-drug resistant Gram-negative bacteria.

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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

Must not have

Females who are pregnant or breastfeeding

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28-35 days after end-of-therapy (eot)

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

No Placebo-Only Group

Approved for 10 Other Conditions

Summary

This trial tests a new antibiotic called contezolid, given either through an injection or as a pill, in adults with moderate or severe diabetic foot infections. The antibiotic works by stopping the bacteria from growing.

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.

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.

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

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My foot infection is classified as moderate or severe.

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I have been diagnosed with diabetes (type 1 or 2).

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My foot infection is below the knee and started at or below the ankle.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have a severe infection or poor blood supply in my foot that might require surgery.

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I had an infection likely caused by bacteria not killed by certain antibiotics.

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I am suspected to have a bone infection.

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I have never taken contezolid acefosamil or contezolid.

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I have a serious liver, kidney, blood, or immune system condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28-35 days after end-of-therapy (eot)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28-35 days after end-of-therapy (eot)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28-35 days after end-of-therapy (eot) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events - symptoms reported by subjects

Clinical laboratory assessment - complete blood count

Vital signs - heart rate

Secondary study objectives

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

Hypokalaemia

Constipation

Anaemia

Hypertension

Urinary tract infection

Nausea

Pyrexia

Hypoglycaemia

Rash

Hypotension

Respiratory failure

Hypomagnesaemia

Decubitus ulcer

Cardiac arrest

Cardio-respiratory arrest

Septic shock

Pneumonia

Sepsis

Atrial fibrillation

Bradycardia

Tachycardia

Vomiting

Generalised oedema

Oedema peripheral

Pain

Fluid overload

Hyperglycaemia

Hypocalcaemia

Hyponatraemia

Hypophosphataemia

Agitation

Anxiety

Depression

Insomnia

Haemorrhagic anaemia

Urinary tract infection fungal

Multi-organ failure

Brain oedema

Renal failure acute

Renal impairment

Acute respiratory distress syndrome

Hypoxia

Pleural effusion

Pulmonary embolism

Respiratory distress

Thrombocytopenia

Angina pectoris

Arrhythmia

Cardiac failure congestive

Supraventricular tachycardia

Ventricular tachycardia

Adrenal insufficiency

Abdominal discomfort

Abdominal distension

Abdominal pain

Dyspepsia

Dysphagia

Ileus

Ileus paralytic

Pancreatitis

Device occlusion

Infusion site phlebitis

Oedema

Bacteraemia

Candidiasis

Cellulitis

Clostridium difficile colitis

Device related infection

Fungal infection

Fungal skin infection

Oral candidiasis

Pneumonia bacterial

Postoperative wound infection

Contusion

Excoriation

Post procedural haemorrhage

Procedural pain

Skin laceration

Alanine aminotransferase increased

Aspartate aminotransferase increased

Blood bilirubin increased

Blood lactate dehydrogenase increased

Blood pressure increased

Fungal test positive

Hepatic enzyme increased

Liver function test abnormal

Platelet count increased

Transaminases increased

Dehydration

Hyperkalaemia

Hypernatraemia

Hypoalbuminaemia

Hypovolaemia

Malnutrition

Metabolic acidosis

Metabolic alkalosis

Pain in extremity

Convulsion

Headache

Somnolence

Confusional state

Disorientation

Restlessness

Haematuria

Oliguria

Urinary retention

Atelectasis

Bronchospasm

Oropharyngeal pain

Pulmonary oedema

Tachypnoea

Erythema

Pruritus

Skin disorder

Skin ulcer

Myocardial infarction

Lung infection

Lung infection pseudomonal

Urinary tract infection pseudomonal

Delirium

Haemoptysis

Hiccups

Laryngeal oedema

Dermatitis

100%

80%

60%

40%

20%

Study treatment Arm

Linezolid

Vancomycin

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: contezolid acefosamil/contezolidExperimental Treatment1 Intervention

Group II: linezolidActive Control1 Intervention

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Diabetic Foot Infection (DFI) often include antibiotics that inhibit bacterial protein synthesis, such as linezolid and contezolid acefosamil. These antibiotics work by binding to bacterial ribosomes, thereby preventing the bacteria from producing essential proteins required for their growth and replication. This mechanism is particularly important for DFI patients as it helps to effectively control and eliminate the infection, reducing the risk of severe complications like sepsis or the need for amputation.