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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER


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505(b)(2) Clinical Trials for Linezolid In Sodium Chloride 0.9% In Plastic Container

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Dosage NCT01734694 ↗ Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients Terminated Henry Ford Health System Phase 4 2011-10-01 For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical concern. This may be due to various reasons, including new dosing recommendations as well as an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity. This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin use.
New Dosage NCT02778828 ↗ Pharmacokinetic and Therapeutic Adaptation of Linezolid in the Treatment of Multi-Resistant Tuberculosis Completed Groupe Hospitalier Paris Saint Joseph N/A 2015-11-04 Linezolid, primary treatment for MDR-TB combination therapy anti. Until it is the dose of 600 mg x1 / day, rather sensible for most patients is more, which was unanimous. It is true that if a dosage is consensus, it goes without saying, because of the interindividual variability, marked moreover to linezolid, a therapeutic monitoring assay of plasma levels is indispensable for most pharmacological treatments. This therapeutic drug monitoring (TDM) often gives rise, as known, to dosage changes. It turns out that at present no real STP on the basic objectives PK / PD is really made in France in the treatment of tuberculosis (TB) and the bibliography remains rather poor recommendations, and yet all the elements are there: indeed linezolid is an antibiotic whose activity is purely "time-dependent". So one should fulfill 2 PK / PD objectives whose precise boundaries are sometimes still to be determined: -% T> MIC, or percentage of time spent with plasma concentrations above the minimum inhibitory concentration of linezolid (LNZ) for Mycobacterium tuberculosis. In practice, the residual concentration before the next shot must be> MIC (0.125 to 1 mg / l) - A fortiori it must also take into account the concentration preventing the appearance of resistant mutants, amounting to 1.2 mg / l - AUC / MIC> 80, or ratio of the area under the curve (AUC, Area under curve) of plasma concentration versus time and CMI LNZ Until then, and without real bibliographic support, and for the sake of kindness to patients coupled with an economic advantage, the STP consisted of 2 samples, a peak 1:30 after taking (Cmax) and a residual before taking (C min) , after all, to 600mg x1 / 24 correlates well with the AUC (55% peak and 75% for the residual). Following an observation that 25 to 30% of patients had a C min <1.2 mg / L, and even frequently <0.2 mg / L to 600 mg x 1, with some low peaks and leaving presage an AUC may be insufficient well. This study is therefore more imperative to be a pharmacological streamlining and ensuring adequate therapeutic monitoring involves both maximum and minimum toxicity efficiency. And in the light of what has already been practiced for other molecules such as mycophenolate for example which is carried AUC or miniAUC for example. It would therefore be in the achievement of AUC in all patients treated with LNZ for TB MDR / XDR for over a week. Achieving this requires AUC obtaining 7 blood samples given day instead of two samples taken at present. Indeed one must have in mind that the peak of rational / residual has become blurred in this context, and that one of the two goals PK / PD is now filled (Cmin> MIC / CMP) but it should not be that not at the expense of the second (AUC). The benefits, direct and indirect are multiple and obtaining them is ensured through this protocol. The study by analyzing individual data will confirm the accuracy of the dose fractionation 300mgx2 / day and at a time to highlight a potential new dosage adjustment that would need to achieve for further study, so a substantial gain in terms of efficacy and toxicity via a suitable therapeutic monitoring. Secondly, determine which collection points, in these patients, these doses will be most interesting to take later in the routine of STP in order to collect less points (eg miniAUC MPA) retaining same statistical power to estimate kinetic parameters, mainly the AUC (eg aminoglycoside also). Finally in a third phase construction on the basis of these individual kinetics of a population pharmacokinetic model with highlighting of population parameters and especially co-related variables explaining the high pharmacokinetic variability and allowing for following patients to determine the individually tailored dose immediately before the first shot and the first assays.
New Indication NCT05069974 ↗ Alternative Antibiotics for Syphilis Recruiting Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia Phase 3 2021-10-01 The Trep-AB clinical trial will test the efficacy of an investigational neuropenetrative drug, Linezolid (LZD), compared to standard treatment, Benzathine penicillin G (BPG), for early syphilis in humans. The overarching idea of the work proposed herein is to investigate the use of LZD to treat syphilis, conducting a randomized controlled clinical trial to evaluate this new indication of a known antibacterial agent. It is estimated to include 360 participants.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Linezolid In Sodium Chloride 0.9% In Plastic Container

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00035269 ↗ New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia) Completed Pfizer Phase 3 2001-12-01 This study will treat patients who have a community-acquired pneumonia that is due to a specific bacteria (S. pneumoniae)
NCT00035425 ↗ Treatment of Neutropenic Patients With Fever Who Are Suspected to Have A Gram Positive Infection Completed Pfizer Phase 3 2001-11-01 This study will treat patients who have fever and neutropenia (after cancer chemotherapy) that is possibly due to a specific bacteria (gram positive bacteria).
NCT00035854 ↗ New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus) Completed Pfizer Phase 3 2002-02-01 This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)
NCT00037050 ↗ Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria Completed Pfizer Phase 3 2002-04-01 This study will treat patients who have a short term central catheter that is thought to be infected with a specific bacteria (gram positive bacteria)
NCT00042289 ↗ Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 2003-03-01 The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Linezolid In Sodium Chloride 0.9% In Plastic Container

Condition Name

Condition Name for Linezolid In Sodium Chloride 0.9% In Plastic Container
Intervention Trials
Tuberculosis 10
Bacterial Infections 9
Tuberculosis, Multidrug-Resistant 8
Pulmonary Tuberculosis 8
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Condition MeSH

Condition MeSH for Linezolid In Sodium Chloride 0.9% In Plastic Container
Intervention Trials
Infections 46
Infection 44
Communicable Diseases 40
Tuberculosis 40
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Clinical Trial Locations for Linezolid In Sodium Chloride 0.9% In Plastic Container

Trials by Country

Trials by Country for Linezolid In Sodium Chloride 0.9% In Plastic Container
Location Trials
United States 438
China 81
South Africa 65
Japan 41
Brazil 29
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Trials by US State

Trials by US State for Linezolid In Sodium Chloride 0.9% In Plastic Container
Location Trials
California 32
Texas 26
Ohio 24
Georgia 23
Florida 22
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Clinical Trial Progress for Linezolid In Sodium Chloride 0.9% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Linezolid In Sodium Chloride 0.9% In Plastic Container
Clinical Trial Phase Trials
Phase 4 20
Phase 3 45
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for Linezolid In Sodium Chloride 0.9% In Plastic Container
Clinical Trial Phase Trials
Completed 74
Recruiting 27
Not yet recruiting 15
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Clinical Trial Sponsors for Linezolid In Sodium Chloride 0.9% In Plastic Container

Sponsor Name

Sponsor Name for Linezolid In Sodium Chloride 0.9% In Plastic Container
Sponsor Trials
Pfizer 30
National Institute of Allergy and Infectious Diseases (NIAID) 7
Global Alliance for TB Drug Development 7
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Sponsor Type

Sponsor Type for Linezolid In Sodium Chloride 0.9% In Plastic Container
Sponsor Trials
Other 295
Industry 89
NIH 9
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Linezolid in Sodium Chloride 0.9% In Plastic Container: Clinical Trials, Market Analysis, and Projections

Introduction

Linezolid, an oxazolidinone-class antibacterial, is widely used for treating various infections caused by Gram-positive bacteria. The formulation of Linezolid in Sodium Chloride 0.9% in a plastic container, such as the VisIV™ Container, has been approved and is in clinical use. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Approved Indications

Linezolid Injection is indicated for the treatment of several infections, including nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections, and vancomycin-resistant Enterococcus faecium infections[1][2].

Clinical Studies

The efficacy of Linezolid has been established through various clinical trials. However, the specific formulation of Linezolid in Sodium Chloride 0.9% did not require new clinical trials, as it relies on the previous findings of safety and efficacy for the referenced product, Zyvox® I.V. (linezolid) injection[2].

Safety and Precautions

Clinical trials and post-marketing data have highlighted several safety concerns, including myelosuppression, peripheral and optic neuropathy, serotonin syndrome, and Clostridioides difficile-associated diarrhea. These side effects are particularly relevant when treating patients for extended periods or those with specific underlying conditions[1].

Therapeutic Drug Monitoring and Elderly Patients

A recent multicentre prospective study emphasized the importance of therapeutic drug monitoring (TDM) in elderly patients receiving linezolid. The study found that linezolid trough concentrations increase significantly with age, and TDM can help predict and manage linezolid-induced thrombocytopenia (LIT)[3].

Market Analysis

Market Position

Linezolid is a key player in the market for antibiotics targeting Gram-positive bacteria. Its unique mechanism of action, which inhibits bacterial protein synthesis by binding to the 23S ribosomal RNA, sets it apart from other antibacterial agents[2].

Competitors

The antibiotic market is highly competitive, with other drugs like vancomycin and daptomycin also targeting similar infections. However, linezolid's oral and intravenous formulations, along with its efficacy against vancomycin-resistant Enterococcus faecium, give it a distinct market position[1].

Market Trends

There is an increasing demand for antibiotics that can effectively treat resistant bacterial infections. The rise in antibiotic resistance has driven the need for drugs like linezolid, which can address these challenging infections. Additionally, the convenience of the plastic container formulation, which is sterile and pyrogen-free, enhances its market appeal[2].

Stability and Shelf Life

Studies on the stability of linezolid in aqueous solutions and intravenous fluids have shown that it maintains over 95% of its initial concentration for up to 34 days at 25°C when added to sodium lactate, 0.9% sodium chloride, and glucose solutions. This stability ensures that the drug remains effective for clinical administration over its shelf life[5].

Projections and Future Outlook

Market Growth

The global antibiotic market is expected to grow significantly due to the increasing incidence of antibiotic-resistant infections. Linezolid, with its proven efficacy and safety profile, is likely to see increased demand, particularly in regions with high rates of vancomycin-resistant infections.

Regulatory Environment

The regulatory environment continues to support the use of linezolid, with no new safety information altering the risk/benefit assessment. The FDA's approval of the Linezolid Injection in 0.9% Sodium Chloride formulation further solidifies its place in the market[2].

Research and Development

Ongoing research, such as the study on therapeutic drug monitoring in elderly patients, will continue to optimize the use of linezolid. Future studies may focus on expanding the indications, improving dosing regimens, and mitigating side effects, which could further enhance its market position.

Key Takeaways

  • Clinical Efficacy: Linezolid is effective against a range of Gram-positive bacterial infections.
  • Safety Concerns: Monitoring is necessary for myelosuppression, neuropathy, and other side effects.
  • Therapeutic Drug Monitoring: Crucial for elderly patients to manage linezolid-induced thrombocytopenia.
  • Market Position: Strong due to its unique mechanism of action and efficacy against resistant infections.
  • Stability: Maintains effectiveness for up to 34 days in various intravenous solutions.
  • Future Outlook: Expected growth in demand driven by increasing antibiotic resistance.

FAQs

Q: What are the approved indications for Linezolid Injection?

A: Linezolid Injection is approved for treating nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections, and vancomycin-resistant Enterococcus faecium infections[1].

Q: Why is therapeutic drug monitoring important for elderly patients on linezolid?

A: Therapeutic drug monitoring is crucial for elderly patients to manage linezolid-induced thrombocytopenia and other side effects, as linezolid trough concentrations increase significantly with age[3].

Q: How stable is linezolid in intravenous solutions?

A: Linezolid maintains over 95% of its initial concentration for up to 34 days at 25°C when added to sodium lactate, 0.9% sodium chloride, and glucose solutions[5].

Q: What are the potential side effects of linezolid?

A: Potential side effects include myelosuppression, peripheral and optic neuropathy, serotonin syndrome, and Clostridioides difficile-associated diarrhea[1].

Q: Is linezolid effective against Gram-negative infections?

A: No, linezolid has no clinical activity against Gram-negative pathogens and is not indicated for the treatment of Gram-negative infections[1].

Sources

  1. Drugs.com: Linezolid Injection: Package Insert / Prescribing Info.
  2. FDA: NDA 206473: Linezolid Injection in 0.9% Sodium Chloride.
  3. PubMed: Therapeutic drug monitoring of linezolid and exploring optimal regimens in elderly patients.
  4. Molina Healthcare: Linezolid C8632-A - Coverage Guideline.
  5. PubMed: Evaluation of the stability of linezolid in aqueous solution and intravenous fluids.

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