New Antibiotics vs Linezolid for Diabetic Foot Infections

Recruiting at 91 trial locations

Overseen By Clinical coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: MicuRx

Must not be taking: Oxazolidinones

Disqualifiers: Osteomyelitis, Necrotizing fasciitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2-4 weeks

865 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new antibiotics to determine if they are more effective and safer than the current treatment, linezolid, for foot infections in people with diabetes. The focus is on moderate to severe infections that began or worsened in the last two weeks. People with diabetes and a recent foot infection below the knee might be suitable for this study. The trial includes two groups: one will receive the new antibiotics, contezolid acefosamil/contezolid, and the other will receive linezolid. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that contezolid acefosamil and contezolid are generally safe. In earlier studies, patients with moderate-to-severe diabetic foot infections tolerated these treatments well. Notably, contezolid may cause fewer bone marrow issues, which is crucial for blood cell production, compared to other treatments, especially with long-term use. This suggests that contezolid could be a safer option for extended treatment.

For those considering joining a clinical trial, it is reassuring that contezolid's safety has been tested in people with similar conditions, providing some confidence in its safety for treating diabetic foot infections. However, discussing any concerns with a doctor is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic foot infections?

Researchers are excited about contezolid acefosamil/contezolid for diabetic foot infections because it offers a potential new approach to fighting bacteria. While standard treatments like linezolid target bacterial protein synthesis, contezolid acefosamil/contezolid is designed to be effective against resistant strains and may have a better safety profile, especially concerning side effects like bone marrow suppression. This new treatment could provide a crucial alternative for patients who experience adverse effects or inadequate results with existing antibiotics.

What evidence suggests that this trial's treatments could be effective for diabetic foot infections?

In this trial, participants will receive either contezolid acefosamil/contezolid or linezolid to treat diabetic foot infections. Research has shown that contezolid acefosamil and contezolid hold promise for treating these infections. Studies have found these antibiotics safe and effective for moderate to severe cases. Specifically, one study noted that patients responded well to contezolid, similar to linezolid, a commonly used antibiotic for this condition. These findings suggest contezolid could serve as a strong alternative for treating diabetic foot infections. Overall, early evidence supports its potential effectiveness in managing this challenging infection. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

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 am suspected to have a bone infection.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Contezolid Acefosamil/Contezolid
• Linezolid

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

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 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]

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 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]

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