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
-

Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease

Not Applicable
Completed
Conditions
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

An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-07-20
Last Posted Date
2013-07-15
Lead Sponsor
Duke University
Target Recruit Count
20
Registration Number
NCT00942149
Locations
🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

Study to Evaluate Daptomycin Given During Dialysis and After Dialysis

First Posted Date
2009-04-16
Last Posted Date
2018-02-06
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
16
Registration Number
NCT00882557
Locations
🇺🇸

West Coast Clinical Trials, Cypress, California, United States

🇺🇸

DaVita Clinical Research, Minneapolis, Minnesota, United States

Pharmacokinetic Study of Daptomycin in Healthy Chinese Subjects Living in China

Phase 1
Completed
Conditions
First Posted Date
2009-03-09
Last Posted Date
2010-01-22
Lead Sponsor
AstraZeneca
Target Recruit Count
24
Registration Number
NCT00858325
Locations
🇨🇳

Research Site, Beijing, China

China Registration Study in Patients With Skin Infections

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-10-15
Last Posted Date
2015-03-09
Lead Sponsor
AstraZeneca
Target Recruit Count
265
Registration Number
NCT00772447
Locations
🇨🇳

Research Site, Qingdao, China

Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections

First Posted Date
2008-07-09
Last Posted Date
2018-09-05
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
396
Registration Number
NCT00711802
Locations
🇺🇸

University of Chicago, Chicago, Illinois, United States

🇺🇸

Children's Hospital Research Center Oakland, Oakland, California, United States

🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

and more 27 locations

Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery

First Posted Date
2008-06-19
Last Posted Date
2016-08-29
Lead Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Target Recruit Count
30
Registration Number
NCT00701636
Locations
🇺🇸

Harbor-UCLA Medical Center, Torrance, California, United States

Phase 2 Study of Safety, Efficacy, and Pharmacokinetics of Higher Doses of Daptomycin and Vancomycin in MRSA Bacteremia

First Posted Date
2008-06-12
Last Posted Date
2018-12-24
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
38
Registration Number
NCT00695903
Locations
🇺🇸

Cleveland Clinic Foundation, Cleveland, Ohio, United States

🇺🇸

East Carolina University, Greenville, North Carolina, United States

PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections

First Posted Date
2008-05-19
Last Posted Date
2019-11-13
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
24
Registration Number
NCT00679835
Locations
🇺🇸

Children's Mercy Hospital, Kansas City, Missouri, United States

Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)

Phase 4
Completed
Conditions
First Posted Date
2008-04-22
Last Posted Date
2015-12-30
Lead Sponsor
University of Michigan
Target Recruit Count
8
Registration Number
NCT00663403
Locations
🇺🇸

University of Michigan University Hospital, Ann Arbor, Michigan, United States

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