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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)

Pharmacokinetics Study of Intraperitoneal Administration of Daptomycin in Peritoneal Infection

Not Applicable
Completed
Conditions
Peritoneal Infection
Interventions
First Posted Date
2013-12-04
Last Posted Date
2018-01-25
Lead Sponsor
University Hospital, Caen
Target Recruit Count
8
Registration Number
NCT02000414
Locations
🇫🇷

Néphrologie CHU de Caen, Caen, France

Vancomycin Versus Daptomycin for the Treatment of Methicillin Resistant Staphylococcus Aureus (MRSA) Bacteremia

Phase 2
Terminated
Conditions
Bacteremia Due to Staphylococcus Aureus
Interventions
First Posted Date
2013-11-05
Last Posted Date
2016-04-14
Lead Sponsor
Singapore General Hospital
Target Recruit Count
14
Registration Number
NCT01975662
Locations
🇸🇬

Singapore General Hospital, Singapore, Singapore

Safety and Efficacy Study of Daptomycin Compared to Active Comparator in Pediatric Participants With Acute Hematogenous Osteomyelitis (AHO) (MK-3009-006)

Phase 3
Completed
Conditions
Acute Hematogenous Osteomyelitis
Interventions
First Posted Date
2013-08-14
Last Posted Date
2018-08-28
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
149
Registration Number
NCT01922011

Efficacy of Daptomycin Plus Fosfomycin Versus Daptomycin for Treatment of MRSA Bacteremia

Phase 3
Completed
Conditions
Staph Aureus Methicillin Resistant Bacteremia
Interventions
First Posted Date
2013-07-12
Last Posted Date
2018-01-17
Lead Sponsor
Miquel Pujol
Target Recruit Count
167
Registration Number
NCT01898338
Locations
🇪🇸

Hospital Universitari Mútua de Terrassa, Terrassa, Barcelona, Spain

🇪🇸

Hospital del Mar- Parc de Salut Mar, Barcelona, Spain

🇪🇸

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

and more 15 locations

Staphylococcus Aureus Bacteremia Antibiotic Treatment Options

Phase 3
Completed
Conditions
Staphylococcus Aureus Infection
Interventions
First Posted Date
2013-02-15
Last Posted Date
2020-05-27
Lead Sponsor
Heinrich-Heine University, Duesseldorf
Target Recruit Count
215
Registration Number
NCT01792804
Locations
🇳🇱

Amsterdam, Amsterdam, Netherlands

🇳🇱

Tilburg, Tilburg, Netherlands

🇳🇱

Diakonessenhuis Utrecht, Utrecht, Netherlands

and more 37 locations

Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients

Phase 4
Terminated
Conditions
Bacteremia
Endocarditis
Health Care Associated Pneumonia
Osteomyelitis/Septic Arthritis
Acute Bacterial Skin and Skin Structure Infections
Interventions
First Posted Date
2012-11-28
Last Posted Date
2023-05-03
Lead Sponsor
Henry Ford Health System
Target Recruit Count
100
Registration Number
NCT01734694
Locations
🇺🇸

Henry Ford Hospital, Detroit, Michigan, United States

Safety & Efficacy of Daptomycin Versus Standard of Care (SOC) in 1 - 17 Year Olds With Staphylococcus Aureus Bacteremia (MK-3009-005)

Phase 4
Completed
Conditions
Bacteremia
Interventions
Drug: Comparator
First Posted Date
2012-11-19
Last Posted Date
2018-08-28
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
82
Registration Number
NCT01728376

The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin

Phase 4
Completed
Conditions
Cellulitis
Interventions
First Posted Date
2012-06-22
Last Posted Date
2015-03-20
Lead Sponsor
Hospital Universitario Evangelico de Curitiba
Target Recruit Count
20
Registration Number
NCT01626560
Locations
🇧🇷

Hospital Universitário Evangelico de Curitiba, Curitiba, Parana, Brazil

Concentration of Antimicrobials in Catheter-lock Solutions

First Posted Date
2012-05-04
Last Posted Date
2015-02-19
Lead Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Target Recruit Count
125
Registration Number
NCT01592032
Locations
🇪🇸

Clinica Universidad de Navarra, Pamplona, Navarra, Spain

Evaluation of Daptomycin for the Emergency Department Treatment of Complicated Skin and Skin Structure Infections

Phase 4
Completed
Conditions
Cellulitis
Skin Infections
Interventions
First Posted Date
2012-03-09
Last Posted Date
2014-08-01
Lead Sponsor
University of Cincinnati
Target Recruit Count
104
Registration Number
NCT01549613
Locations
🇺🇸

University of Cincinnati, Dept. of Emergency Medicine, Cincinnati, Ohio, United States

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