Daptomycin

Generic Name
Daptomycin
Brand Names
Cubicin, Dapzura, Daptomycin Hospira
Drug Type
Small Molecule
Chemical Formula
C72H101N17O26
CAS Number
103060-53-3
Unique Ingredient Identifier
NWQ5N31VKK
Background

Daptomycin is a cyclic lipopeptide antibacterial agent with a broad spectrum of activity against Gram-positive bacteria, including methicillin-susceptible and -resistant Staphylococcus aureus (MSSA/MRSA) and vancomycin-resistant Enterococci (VRE). Chemically, daptomycin comprises 13 amino acids, including several non-standard and D-amino acids, with the C-terminal 10 amino acids forming an ester-linked ring and the N-terminal tryptophan covalently bonded to decanoic acid. Daptomycin was first discovered in the early 1980s by researchers at Eli Lilly in soil samples from Mount Ararat in Turkey. Early work on developing daptomycin was abandoned due to observed myopathy but was resumed in 1997 when Cubist Pharmaceuticals Inc. licensed daptomycin; it was found that a once-daily dosing scheme reduced side effects while retaining efficacy.

Daptomycin was approved by the FDA on September 12, 2003, and is marketed under the name CUBICIN® by Cubist Pharmaceuticals LLC (Merck & Co.).

Indication

Daptomycin is indicated for the treatment of complicated skin and skin structure infections (cSSSI) in patients one year of age and older. It is also indicated for the treatment of Staphylococcus aureus bloodstream infections (bacteremia) in patients one year of age and older, including in adult patients with right-sided infective endocarditis.

Daptomycin is not indicated for the treatment of pneumonia or left-sided infective endocarditis due to S. aureus. Use is not recommended in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or

central).

As with all antibacterial drugs, it is strongly suggested to perform sufficient testing before treatment initiation in order to confirm an infection caused by susceptible bacteria. Failure to do so may result in suboptimal treatment, treatment failure, and the development of drug-resistant bacteria.

Associated Conditions
Complicated Skin and Skin Structure Infection, Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia)
Associated Therapies
-

Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2010-09-13
Last Posted Date
2024-03-18
Lead Sponsor
Ruhr University of Bochum
Target Recruit Count
1
Registration Number
NCT01199783
Locations
🇩🇪

Herz- und Diabeteszentrum, Bad Oeynhausen, Germany

Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA) Colonized Adult Patients Undergoing Primary Elective Hip, Knee, or Shoulder Arthroplasty

First Posted Date
2010-09-08
Last Posted Date
2014-02-03
Lead Sponsor
Mountain Home Research & Education Corporation
Target Recruit Count
28
Registration Number
NCT01196169
Locations
🇺🇸

Johnson City Medical Center, Johnson City, Tennessee, United States

🇺🇸

James H Quillen VA Medical Center, Mountain Home, Tennessee, United States

Study to Compare Efficacy and Safety of Daptomycin in Elderly Patients With Complicated Skin and Soft Tissue Infections

First Posted Date
2010-08-19
Last Posted Date
2012-07-13
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
120
Registration Number
NCT01184872
Locations
🇪🇸

Novartis Investigative Site, Seville, Spain

🇷🇺

Novartis Investigative Site (2), Saint Petersburg, Russian Federation

🇪🇸

Novartis Investigative Site (1), Madrid, Spain

Study Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting

First Posted Date
2010-08-05
Last Posted Date
2018-12-26
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
80
Registration Number
NCT01175707
Locations
🇺🇸

Heartland I.V. Care, Pittsburgh, Pennsylvania, United States

🇺🇸

NationsMed Clinical Research, Inc., Stafford, Texas, United States

Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration

Phase 2
Conditions
First Posted Date
2010-07-28
Last Posted Date
2010-07-28
Lead Sponsor
University of Zurich
Target Recruit Count
15
Registration Number
NCT01171547
Locations
🇨🇭

Medical Intensive Care Unit, University Hospital Zurich, Zurich, Switzerland

Daptomycin With Rifampin for Treatment of Staphylococcal Prosthetic Joint Infection

Phase 2
Conditions
Interventions
First Posted Date
2010-06-15
Last Posted Date
2012-06-26
Lead Sponsor
Andrej Trampuz
Target Recruit Count
60
Registration Number
NCT01144000
Locations
🇨🇭

Schulhess Clinic, Zurich, Switzerland

🇨🇭

Centre hospitaliere universitaire vaudois (CHUV), Lausanne, Vaud, Switzerland

🇨🇭

Kantonsspital, Liestal, Switzerland

Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections

Phase 4
Completed
Conditions
Interventions
First Posted Date
2010-03-05
Last Posted Date
2012-04-17
Lead Sponsor
Hannover Medical School
Target Recruit Count
650
Registration Number
NCT01080963
Locations
🇩🇪

Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular surgery, Hannover, Germany

Cerebrospinal Fluid Pharmacokinetics of Daptomycin

Not Applicable
Terminated
Conditions
Interventions
First Posted Date
2009-12-03
Last Posted Date
2013-08-12
Lead Sponsor
University of Pittsburgh
Target Recruit Count
2
Registration Number
NCT01025271
Locations
🇺🇸

UPMC, PIttsburgh, Pennsylvania, United States

Pharmacokinetics (PK) and Safety Evaluation of Daptomycin in Children Ages 3-24 Months With Proven or Suspected Gram-positive Infections or Peri-Operative Subjects Receiving Prophylactic Antibiotics

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-11-25
Last Posted Date
2019-11-13
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
23
Registration Number
NCT01019395
Locations
🇺🇸

University of Louisiana at Monroe, Shreveport, Louisiana, United States

🇺🇸

Cook Children's Medical Center, Fort Worth, Texas, United States

🇺🇸

University Hospitals Case Medical Center, Cleveland, Ohio, United States

and more 5 locations
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