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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)

Daptomycin in Pediatric Patients With Bacterial Meningitis

Phase 1
Terminated
Conditions
Meningitis
Interventions
First Posted Date
2012-01-31
Last Posted Date
2018-10-11
Lead Sponsor
Insel Gruppe AG, University Hospital Bern
Target Recruit Count
1
Registration Number
NCT01522105
Locations
🇨🇭

Dep. of Pediatrics, University Hospital Bern, Bern, Switzerland

Daptomycin Versus Vancomycin in the Treatment of Nosocomial or Healthcare-associated MRSA Bacteremia

Phase 3
Terminated
Conditions
Nosocomial Infection
Healthcare-associated Infection
Interventions
First Posted Date
2012-01-23
Last Posted Date
2014-08-26
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
10
Registration Number
NCT01515020
Locations
🇫🇷

Hopital Beaujon, Clichy cedex, France

Daptomycin + Meropenem Versus Ceftazidime in the Treatment of Nosocomial Spontaneous Bacterial Peritonitis

Phase 2
Terminated
Conditions
Cirrhosis
Nosocomial Spontaneous Bacterial Peritonitis
Ascites
Interventions
First Posted Date
2011-10-19
Last Posted Date
2014-10-15
Lead Sponsor
University of Padova
Target Recruit Count
32
Registration Number
NCT01455246
Locations
🇮🇹

Dept. of Clinical and Experimental Medicine, University of Padova, Padova, PD, Italy

Daptomycin Versus Vancomycin in Participants With Skin Infections Due to MRSA

Phase 4
Completed
Conditions
Staphylococcal Skin Infections
Interventions
First Posted Date
2011-08-18
Last Posted Date
2018-09-05
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
250
Registration Number
NCT01419184

Vancomycin Versus Daptomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations (MICs)

Phase 4
Terminated
Conditions
Bacteremia
Interventions
First Posted Date
2011-02-01
Last Posted Date
2014-02-10
Lead Sponsor
St. John Health System, Michigan
Target Recruit Count
11
Registration Number
NCT01287832

Daptomycin Versus Placebo in Patients With Neutropenia and Fever

Phase 3
Terminated
Conditions
Febrile Neutropenia
Interventions
Other: Saline Placebo
First Posted Date
2010-10-07
Last Posted Date
2014-04-10
Lead Sponsor
University of Rochester
Target Recruit Count
36
Registration Number
NCT01216241
Locations
🇺🇸

University of Rochester Medical Center, Rochester, New York, United States

Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Finding Study

Phase 2
Conditions
Gram-Positive Bacterial Infections
First Posted Date
2010-09-30
Last Posted Date
2010-10-18
Lead Sponsor
University of Zurich
Target Recruit Count
15
Registration Number
NCT01212432

Initial Treatment for Acute Bacterial Skin Infections (ABSSSI) Caused by Staphylococcus Aureus

Phase 2
Completed
Conditions
Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA)
(Susceptible or Methicillin Resistant)
Interventions
Drug: PMX-30063-investigational drug
First Posted Date
2010-09-29
Last Posted Date
2012-05-17
Lead Sponsor
PolyMedix, Inc.
Target Recruit Count
215
Registration Number
NCT01211470
Locations
🇷🇺

11 Sites, Multiple, Russian Federation

🇺🇦

5 Sites, Multiple, Ukraine

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

Phase 3
Terminated
Conditions
Diabetic Foot
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

Phase 4
Terminated
Conditions
Staphylococcal Infections
Methicillin-resistant Staphylococcus Aureus
Interventions
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

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