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Last Updated: November 15, 2019

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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 NCT02778828 Pharmacokinetic and Therapeutic Adaptation of Linezolid in the Treatment of Multi-Resistant Tuberculosis Recruiting Groupe Hospitalier Paris Saint Joseph N/A 2015-09-01 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.
>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)
NCT00084266 Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA) Completed Pfizer Phase 4 2004-10-01 To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult subjects. Subjects entered in to the study will have proven healthcare-associated methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either linezolid or vancomycin.
NCT00087490 Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA) Completed Pfizer Phase 4 2004-10-01 To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects
NCT00108433 Linezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections Terminated Pfizer Phase 3 2005-09-01 This study will treat hemodialysis patients who have a central catheter that is thought to be infected with a specific bacteria (Gram positive bacteria).
>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
Bacterial Infections 9
Gram-positive Bacterial Infections 8
Pneumonia 6
Tuberculosis 6
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Condition MeSH

Condition MeSH for Linezolid In Sodium Chloride 0.9% In Plastic Container
Intervention Trials
Infection 41
Communicable Diseases 36
Tuberculosis 27
Bacterial Infections 22
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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 365
China 45
South Africa 43
Brazil 15
Spain 15
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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 27
Georgia 22
Texas 22
Ohio 20
Florida 19
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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 16
Phase 3 37
Phase 2/Phase 3 4
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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 52
Not yet recruiting 20
Recruiting 19
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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 29
Global Alliance for TB Drug Development 5
Paratek Pharmaceuticals Inc 5
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Sponsor Type

Sponsor Type for Linezolid In Sodium Chloride 0.9% In Plastic Container
Sponsor Trials
Other 138
Industry 75
U.S. Fed 3
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