MedPath

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)

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

Phase 3
Completed
Conditions
Infections
Interventions
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

Phase 4
Terminated
Conditions
Complicated Skin or Skin Structure Infection
Interventions
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
Bacteremia
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
Staphylococcal Infections
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

Outpatient Treatment of Gram Positive Wound Infections in the Diabetic Foot: A Pharmaco-economic Comparison of Daptomycin vs. Vancomycin Based Regimens

Phase 4
Terminated
Conditions
Diabetic Foot
Interventions
First Posted Date
2010-05-31
Last Posted Date
2013-09-10
Lead Sponsor
Clinical Alliance for Research & Education - Infectious Diseases, LLC.
Target Recruit Count
6
Registration Number
NCT01133600
Locations
🇺🇸

Clinical Alliance for Research & Education, Infectious Diseases, LlC, Annandale, Virginia, United States

🇺🇸

Infuscience, Annandale, Virginia, United States

Study of Daptomycin Safety and Efficacy for Complicated Skin and Skin Structure Infections (cSSSI) and Bacteremia in Renal Impairment

Phase 4
Terminated
Conditions
Complicated Skin and Skin Structure Infections
S. Aureus Bacteremia
Renal Impairment
Interventions
Drug: Semi-Synthetic Penicillin
First Posted Date
2010-04-15
Last Posted Date
2018-09-05
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
92
Registration Number
NCT01104662

Daptomycin as Antibiotic Prophylaxis of Sternal Wound Infections

Phase 4
Completed
Conditions
Wound Infection
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
Meningitis
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
Gram Positive Bacterial Infection
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

Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease

Not Applicable
Completed
Conditions
Bacterial Infection
Chronic Kidney Disease
Interventions
First Posted Date
2009-11-11
Last Posted Date
2018-06-06
Lead Sponsor
University of Oklahoma
Target Recruit Count
6
Registration Number
NCT01012089
Locations
🇺🇸

The Children's Hospital at the University of Oklahoma Medical Center, Oklahoma City, Oklahoma, United States

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