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Last Updated: January 17, 2022

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CLINICAL TRIALS PROFILE FOR CUBICIN RF

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505(b)(2) Clinical Trials for Cubicin Rf

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Cubicin Rf

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00295178 ↗ Study Comparing CUBICINĀ® (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas Completed Cubist Pharmaceuticals LLC Phase 4 2006-02-20 This study is designed to investigate the difference in speed and degree of symptom resolution between daptomycin and vancomycin in subjects treated for cellulitis or erysipelas by evaluation of the following parameters: - Time to erythema margin cessation to progress - Time to defervescence - Time to hospital discharge following relief of the presenting cellulitis or erysipelas - Degree of improvement of the following signs and symptom of cellulitis or erysipelas including - Degree of improvement of cellulitis-related pain and swelling as reported by subjects Additionally, the difference in frequency of Adverse Events between daptomycin and vancomycin will be described.
NCT00335478 ↗ Daptomycin in Treating Neutropenia and Fever in Patients With Cancer Completed OHSU Knight Cancer Institute Phase 2 2006-12-01 RATIONALE: Antibiotics, such as daptomycin, may control neutropenia, fever, and infection in patients with cancer. PURPOSE: This phase II trial is studying how well daptomycin works in treating neutropenia and fever in patients with cancer.
NCT00401960 ↗ Daptomycin as an Adjuvant Agent in the Treatment of Enterococcal Native Valve Endocarditis. Terminated Weill Medical College of Cornell University Phase 4 2006-09-01 The aim of this study is to determine the safety and efficacy of daptomycin when used as an adjuvant agent to standard care in the treatment of proven native valve Enterococcal endocarditis. Patients with this disease will be offered the option of receiving daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving. The hypothesis of this study is that daptomycin added to standard therapy for Enterococcal endocarditis is safe and efficacious. Patients who receive daptomycin + standard therapy will be compared to patients who receive standard therapy alone with respect to the following outcomes: 1. Safety. 1. The frequency of any Grade 3 or 4 toxicity (DAIDS scale) will be measured. 2. The frequency of muscle toxicity or renal toxicity, as determined by predefined criteria. 2. Efficacy. 1. Clinical efficacy. - Time to clearance of bacteremia - Cure at 6 weeks following completion of antibiotic therapy - Mortality at 6 weeks following completion of antibiotic therapy 2. Microbiologic efficacy. - Peak and trough serum bactericidal titers - The minimum bactericidal concentration of Enterococci to daptomycin We expect to enroll 40 patients over 2 years.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cubicin Rf

Condition Name

Condition Name for Cubicin Rf
Intervention Trials
Bacteremia 5
Staphylococcal Infections 3
Diabetic Foot 2
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Condition MeSH

Condition MeSH for Cubicin Rf
Intervention Trials
Infections 13
Infection 13
Communicable Diseases 13
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Clinical Trial Locations for Cubicin Rf

Trials by Country

Trials by Country for Cubicin Rf
Location Trials
United States 88
China 10
Switzerland 3
Germany 2
United Kingdom 2
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Trials by US State

Trials by US State for Cubicin Rf
Location Trials
California 8
Texas 8
Ohio 7
Michigan 5
North Carolina 5
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Clinical Trial Progress for Cubicin Rf

Clinical Trial Phase

Clinical Trial Phase for Cubicin Rf
Clinical Trial Phase Trials
Phase 4 16
Phase 3 7
Phase 2 9
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Clinical Trial Status

Clinical Trial Status for Cubicin Rf
Clinical Trial Phase Trials
Completed 21
Terminated 15
Unknown status 2
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Clinical Trial Sponsors for Cubicin Rf

Sponsor Name

Sponsor Name for Cubicin Rf
Sponsor Trials
Cubist Pharmaceuticals LLC 22
M.D. Anderson Cancer Center 3
University of Rochester 1
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Sponsor Type

Sponsor Type for Cubicin Rf
Sponsor Trials
Other 31
Industry 28
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Serving leading biopharmaceutical companies globally:

Colorcon
Merck
Medtronic
Mallinckrodt
McKinsey
Moodys

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