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
| 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 | >Sponsor | >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. | |
| NCT00042289 ↗ | Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 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. | |
| 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
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| Sponsor Name for LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | |
| Sponsor | Trials |
| Pfizer | 30 |
| Global Alliance for TB Drug Development | 7 |
| National Institute of Allergy and Infectious Diseases (NIAID) | 7 |
| [disabled in preview] | 21 |
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