Claim Your New User Special: Get your second month free ▶ Second Month Free

Serving leading biopharmaceutical companies globally:

Johnson and Johnson

Last Updated: May 26, 2022


✉ Email this page to a colleague

« Back to Dashboard

505(b)(2) Clinical Trials for Linezolid

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

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)
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Linezolid

Condition Name

Condition Name for Linezolid
Intervention Trials
Tuberculosis 9
Bacterial Infections 9
Gram-positive Bacterial Infections 8
Tuberculosis, Multidrug-Resistant 8
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Linezolid
Intervention Trials
Infections 45
Infection 44
Communicable Diseases 39
Tuberculosis 34
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Linezolid

Trials by Country

Trials by Country for Linezolid
Location Trials
United States 436
China 73
South Africa 61
Japan 41
Brazil 27
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Linezolid
Location Trials
California 31
Texas 26
Ohio 24
Georgia 23
Florida 22
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Linezolid

Clinical Trial Phase

Clinical Trial Phase for Linezolid
Clinical Trial Phase Trials
Phase 4 17
Phase 3 43
Phase 2/Phase 3 7
[disabled in preview] 28
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Linezolid
Clinical Trial Phase Trials
Completed 74
Recruiting 23
Terminated 10
[disabled in preview] 9
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Linezolid

Sponsor Name

Sponsor Name for Linezolid
Sponsor Trials
Pfizer 29
Global Alliance for TB Drug Development 6
Paratek Pharmaceuticals Inc 5
[disabled in preview] 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Linezolid
Sponsor Trials
Other 247
Industry 85
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.