New Antibiotics vs Linezolid for Diabetic Foot Infections

Recruiting in Palo Alto (17 mi)

+85 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: MicuRx

Must not be taking: Oxazolidinones

Disqualifiers: Osteomyelitis, Necrotizing fasciitis, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Linezolid for treating diabetic foot infections?

Linezolid has been shown to be at least as effective as other antibiotics for treating foot infections in diabetic patients, with a clinical cure rate of 81% compared to 71% for other treatments. It is particularly effective for infected foot ulcers and for patients without bone infections, although it may cause mild and reversible side effects. ^{1 2 3 4 5}

Is linezolid safe for treating infections?

Linezolid is generally well-tolerated, but it can cause some side effects like bone marrow suppression (a decrease in blood cell production), peripheral neuropathy (nerve damage), and hyponatremia (low sodium levels). It is important to monitor for these effects, especially in long-term use. ^{3 4 5 6 7}

What makes the drug Contezolid Acefosamil/Contezolid unique for diabetic foot infections?

Contezolid Acefosamil/Contezolid is unique because it is part of a new class of antibiotics called oxazolidinones, which are effective against serious Gram-positive infections, including those resistant to other antibiotics like methicillin and vancomycin. This drug can be administered both orally and intravenously, offering flexibility in treatment and potentially reducing hospital stays. ^{3 4 5 8 9}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

My foot infection is classified as moderate or severe.

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

My foot infection started or got worse in the last 2 weeks.

Exclusion Criteria

I am not pregnant or breastfeeding.

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

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive contezolid acefosamil/contezolid or linezolid for 14 to 28 days

2-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-5 weeks

Treatment Details

Interventions

• Contezolid Acefosamil/Contezolid (Oxazolidinone Antibiotic)
• Linezolid (Oxazolidinone Antibiotic)

Trial Overview 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.

Participant Groups

Group I: contezolid acefosamil/contezolid Experimental Treatment 1 Intervention

Group II: linezolid Active Control 1 Intervention

Contezolid Acefosamil/Contezolid is already approved in China for the following indications:

Approved in China as Contezolid for:

• Complicated skin and soft tissue infections (cSSTIs)

Who Is Running the Clinical Trial?

MicuRx

Lead Sponsor

Trials

6

Recruited

1,500+

Findings from Research

In a study of 371 diabetic patients with foot infections, linezolid showed equivalent clinical cure rates to standard treatments, with a notable advantage in patients with infected foot ulcers (81% vs. 68%) and those without osteomyelitis (87% vs. 72%).

While linezolid was effective, it had a higher incidence of mild and reversible drug-related adverse events compared to the comparator drugs, indicating a trade-off between efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating foot infections in diabetic patients: a randomized, multicenter, open-label trial of linezolid versus ampicillin-sulbactam/amoxicillin-clavulanate. Lipsky, BA., Itani, K., Norden, C.[2022]

In a study of 704 patients with diabetes foot ulcers, 17% had MRSA infections, and 28% of those were treated with linezolid, leading to a significant reduction in hospital admissions and costs.

The use of linezolid according to guidelines resulted in 91% of patients either avoiding admission or being discharged early, while also saving £210,000 in inpatient costs despite the treatment's high price.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost avoidance using linezolid for methicillin-resistant Staphylococcus aureus infections in a specialist diabetes foot clinic. Young, MJ., Hodges, G., McCardle, JE.[2016]

Linezolid (Zyvox) is a novel antibiotic effective against serious Gram-positive infections, including those caused by drug-resistant bacteria like MRSA and VRE, showing comparable efficacy to vancomycin.

It works by inhibiting bacterial protein synthesis through binding to the ribosome, and recent studies suggest that related compounds may also be effective against resistant strains of tuberculosis, indicating potential for broader therapeutic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linezolid, the first oxazolidinone antibacterial agent. Leach, KL., Brickner, SJ., Noe, MC., et al.[2019]

Linezolid is the first oxazolidinone antibiotic approved for treating various infections, including pneumonia and skin infections, particularly those caused by resistant bacteria like MRSA.

The manufacturer claims that patients can switch from intravenous to oral linezolid without needing a dose adjustment, potentially allowing for earlier discharge from the hospital and shorter overall hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linezolid for gram-positive infections. [2019]

Linezolid is a new class of antibiotic effective against resistant Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus faecium, with clinical trials showing it is effective for various infections.

It is well-tolerated with good bioavailability and tissue penetration, but caution is needed due to its potential to cause reversible thrombocytopenia and its interaction with certain medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of linezolid: the first oxazolidinone antibiotic. Stevens, DL., Dotter, B., Madaras-Kelly, K.[2019]

Linezolid, an antibiotic used for various infections, can cause severe adverse effects such as hypoglycemia, bone marrow suppression, and hyponatremia, as demonstrated in a case involving an 82-year-old patient who developed these complications after treatment.

This case is notable because it presents a rare combination of linezolid-induced hypoglycemia and myelosuppression in a non-diabetic patient, highlighting the need for careful monitoring of blood sugar levels and blood counts in patients receiving this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linezolid-induced rare triad of hypoglycaemia, bone marrow suppression and hyponatraemia in elderly. Singhania, SVK., Shenoy, S., Kapoor, D.[2020]

Linezolid is rapidly absorbed with high bioavailability (>95% in rats and dogs, >70% in mice) and shows consistent absorption, distribution, metabolism, and excretion (ADME) profiles across species, supporting its safety in preclinical studies.

The drug is primarily excreted as the parent compound and two inactive metabolites, with renal excretion being a major elimination route, indicating a slow metabolic process that influences overall clearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, toxicokinetics, distribution, metabolism and excretion of linezolid in mouse, rat and dog. Slatter, JG., Adams, LA., Bush, EC., et al.[2019]

Linezolid is an effective treatment for serious Gram-positive infections, including those caused by multidrug-resistant bacteria like MRSA, showing similar clinical cure rates to vancomycin and teicoplanin in randomized trials.

It offers practical advantages such as 100% oral bioavailability, allowing for easy transition from intravenous to oral administration, which may lead to reduced hospital stays and lower overall treatment costs compared to vancomycin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linezolid: a pharmacoeconomic review of its use in serious Gram-positive infections. Plosker, GL., Figgitt, DP.[2018]

Linezolid demonstrated strong in vitro activity against all tested strains of Nocardia brasiliensis, with a MIC(90) of 2 microg/ml and MIC(50) of 1 microg/ml, indicating its effectiveness as an antimicrobial agent.

Given its sensitivity profile, linezolid could be a promising alternative treatment for actinomycetoma, a condition caused by N. brasiliensis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro activity of PNU-100766 (linezolid), a new oxazolidinone antimicrobial, against Nocardia brasiliensis. Vera-Cabrera, L., Gómez-Flores, A., Escalante-Fuentes, WG., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treating foot infections in diabetic patients: a randomized, multicenter, open-label trial of linezolid versus ampicillin-sulbactam/amoxicillin-clavulanate. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Cost avoidance using linezolid for methicillin-resistant Staphylococcus aureus infections in a specialist diabetes foot clinic. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Linezolid, the first oxazolidinone antibacterial agent. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Linezolid for gram-positive infections. [2019]

5. England pubmed.ncbi.nlm.nih.gov

A review of linezolid: the first oxazolidinone antibiotic. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Linezolid-induced rare triad of hypoglycaemia, bone marrow suppression and hyponatraemia in elderly. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, toxicokinetics, distribution, metabolism and excretion of linezolid in mouse, rat and dog. [2019]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Linezolid: a pharmacoeconomic review of its use in serious Gram-positive infections. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

In vitro activity of PNU-100766 (linezolid), a new oxazolidinone antimicrobial, against Nocardia brasiliensis. [2018]