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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)

Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia

Phase 3
Completed
Conditions
Staphylococcus Aureus Bacteremia
Interventions
First Posted Date
2017-05-03
Last Posted Date
2023-11-08
Lead Sponsor
Basilea Pharmaceutica
Target Recruit Count
390
Registration Number
NCT03138733
Locations
🇺🇸

Remington Davis Inc., Columbus, Ohio, United States

🇮🇹

Giuliano Isontina University Health Authority, Trieste, Italy

🇮🇱

The Baruch Padeh Medical Center, Poriyya 'Illit, Israel

and more 57 locations

Daptomycin Concentration in Drainage Fluid and Blood Samples of ICU Patients

Completed
Conditions
Heart Assist Device
First Posted Date
2016-12-28
Last Posted Date
2019-04-19
Lead Sponsor
University Hospital Tuebingen
Target Recruit Count
9
Registration Number
NCT03004066
Locations
🇩🇪

University Hospital Tuebingen, Tuebingen, Germany

Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia

Phase 4
Completed
Conditions
Methicillin Susceptible Staphylococcus Aureus Septicemia
Bacteremia
Interventions
Other: Placebo
First Posted Date
2016-11-25
Last Posted Date
2020-09-22
Lead Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Target Recruit Count
102
Registration Number
NCT02972983
Locations
🇨🇦

McGill University Health Centre (Royal Victoria Hospital, Montreal Neurological Hospital, and Montreal General Hospital), Montreal, Quebec, Canada

IL-10 Stratifying Tool for Towards Antibiotic Selection for MRSaB

Phase 4
Completed
Conditions
Bacteremia
Interventions
First Posted Date
2016-01-21
Last Posted Date
2018-02-01
Lead Sponsor
Sharp HealthCare
Target Recruit Count
40
Registration Number
NCT02660346
Locations
🇺🇸

Sharp Grossmont Hospital, La Mesa, California, United States

🇺🇸

Sharp Memorial Hospital, San Diego, California, United States

The Pharmacokinetics/Pharmacodynamics of High-dose Daptomycin in Patients With Septic Shock

Not Applicable
Conditions
Septic Shock
Interventions
Other: determination of plasma concentration
First Posted Date
2015-07-24
Last Posted Date
2015-07-24
Lead Sponsor
Zhongda Hospital
Target Recruit Count
12
Registration Number
NCT02508350
Locations
🇨🇳

Zhongda hospital, Southeast University, Nanjing, Jiangsu, China

Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury

Phase 4
Withdrawn
Conditions
Burn Injury
Interventions
First Posted Date
2014-09-16
Last Posted Date
2016-10-28
Lead Sponsor
University of Zurich
Registration Number
NCT02241941
Locations
🇨🇭

University Hospital Zurich, Zurich, Switzerland

A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial

Phase 3
Terminated
Conditions
Bacteremia
Interventions
First Posted Date
2014-08-04
Last Posted Date
2020-02-17
Lead Sponsor
Cumberland Pharmaceuticals
Target Recruit Count
121
Registration Number
NCT02208063
Locations
🇺🇸

Remington-Davis Clinical Research, Columbus, Ohio, United States

Population Pharmacokinetic (PK) Study of Multiple Doses of Cubicin® (Daptomycin) 10 mg/kg in Critical Care Patients Having Bacteremia, Endocarditis or Skin Soft Tissue Infections Due to Gram Positive Bacteria With Various Degrees of Renal Failure

Phase 3
Completed
Conditions
Critical Care
Gram Positive Bacteria
Renal Failure
Interventions
First Posted Date
2014-05-20
Last Posted Date
2016-10-11
Lead Sponsor
Poitiers University Hospital
Registration Number
NCT02142075
Locations
🇫🇷

Lasocki S, University Hospital of Angers, Angers, France

🇫🇷

Seguin P, University Hospital of Rennes, Rennes, France

🇫🇷

Asehnoune K, University Hospital of Nantes, Nantes, France

and more 1 locations

Influence of Rifampin Co-Administration on the Pharmacokinetic Profile of Daptomycin

Early Phase 1
Completed
Conditions
Drug Interactions
Pharmacokinetics
Interventions
First Posted Date
2014-03-27
Last Posted Date
2016-12-12
Lead Sponsor
University of Utah
Target Recruit Count
12
Registration Number
NCT02097953
Locations
🇺🇸

University of Utah, Salt Lake City, Utah, United States

Efficacy and Safety Study of Brilacidin to Treat Serious Skin Infections

Phase 2
Completed
Conditions
Skin Infection
Bacterial Infection
Interventions
First Posted Date
2014-02-03
Last Posted Date
2018-09-26
Lead Sponsor
Cellceutix Corporation
Target Recruit Count
215
Registration Number
NCT02052388
Locations
🇺🇸

eStudy Site, Las Vegas, Nevada, United States

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