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Last Updated: November 28, 2022

CLINICAL TRIALS PROFILE FOR CUBICIN


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505(b)(2) Clinical Trials for Cubicin

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

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.
NCT00428844 ↗ Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci Completed Cubist Pharmaceuticals LLC Phase 2 2007-06-26 This is a research study designed to look at the efficacy and safety of daptomycin given at a dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections caused by Staphylococci. These types of bacteria are among the most common types of bacteria causing infections of prosthetic joints.
NCT00430937 ↗ Efficacy and Safety of Daptomycin Versus Vancomycin or Teicoplanin for Treatment of Complicated Skin and Soft Tissue Infections Terminated Novartis Pharmaceuticals Phase 3 2006-04-01 This study evaluated the efficacy and safety of daptomycin compared to vancomycin or teicoplanin for the treatment of complicated skin and soft tissue infections
NCT00467272 ↗ Catheter Related - Gram Positive Bloodstream Infections Completed Cubist Pharmaceuticals LLC Phase 2 2007-03-01 Primary Objective: -Evaluate the clinical efficacy and safety of Daptomycin given for treatment of catheter-related bloodstream infections (CRBSI) due to gram positive bacteremia in the context of standard of care antimicrobial therapy consisting mainly of Vancomycin with or without initial treatment with beta lactam antibiotics.
NCT00467272 ↗ Catheter Related - Gram Positive Bloodstream Infections Completed M.D. Anderson Cancer Center Phase 2 2007-03-01 Primary Objective: -Evaluate the clinical efficacy and safety of Daptomycin given for treatment of catheter-related bloodstream infections (CRBSI) due to gram positive bacteremia in the context of standard of care antimicrobial therapy consisting mainly of Vancomycin with or without initial treatment with beta lactam antibiotics.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cubicin

Condition Name

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

Condition MeSH for Cubicin
Intervention Trials
Communicable Diseases 13
Infections 13
Infection 13
Bacteremia 8
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Clinical Trial Locations for Cubicin

Trials by Country

Trials by Country for Cubicin
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
Location Trials
California 8
Texas 8
Ohio 7
Minnesota 5
Michigan 5
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Clinical Trial Progress for Cubicin

Clinical Trial Phase

Clinical Trial Phase for Cubicin
Clinical Trial Phase Trials
Phase 4 16
Phase 3 7
Phase 2 9
[disabled in preview] 8
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Clinical Trial Status

Clinical Trial Status for Cubicin
Clinical Trial Phase Trials
Completed 21
Terminated 15
Unknown status 2
[disabled in preview] 2
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Clinical Trial Sponsors for Cubicin

Sponsor Name

Sponsor Name for Cubicin
Sponsor Trials
Cubist Pharmaceuticals LLC 22
M.D. Anderson Cancer Center 3
Cumberland Pharmaceuticals 1
[disabled in preview] 4
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Sponsor Type

Sponsor Type for Cubicin
Sponsor Trials
Other 31
Industry 28
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