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)

Daptomycin Vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia

Phase 4
Recruiting
Conditions
Staphylococcus Aureus Septicemia
Staphylococcus Aureus Bacteremia
S. Aureus Bacteremia
S. Aureus Bloodstream Infection
Staphylococcus Aureus Endocarditis
Interventions
First Posted Date
2024-10-15
Last Posted Date
2024-11-27
Lead Sponsor
Todd C. Lee MD MPH FIDSA
Target Recruit Count
300
Registration Number
NCT06637332
Locations
🇨🇦

Fraser Health Authority (Surrey Memorial Hospital), Surrey, British Columbia, Canada

🇨🇦

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

PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN

Phase 2
Completed
Conditions
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Interventions
First Posted Date
2021-07-30
Last Posted Date
2024-11-04
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
100
Registration Number
NCT04983901
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia

Phase 2
Completed
Conditions
Staphylococcal Bacteraemia
Interventions
First Posted Date
2021-03-01
Last Posted Date
2024-12-10
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
200
Registration Number
NCT04775953
Locations
🇺🇸

Corewell Health - Infectious Disease, Royal Oak, Michigan, United States

🇺🇸

University of Alabama Hospital - Infectious Diseases, Birmingham, Alabama, United States

🇺🇸

University of California Davis Medical Center - Internal Medicine - Infectious Disease, Sacramento, California, United States

and more 21 locations

The Efficacy and Safety of Daptomycin in the Treatment of Gram-positive Bacterial Infection.

Conditions
Antibiotic
Interventions
First Posted Date
2020-09-14
Last Posted Date
2020-09-17
Lead Sponsor
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Target Recruit Count
2000
Registration Number
NCT04546815
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, Beijing, China

Subcutaneous Daptomycin in Healthy Volunteers (DAPTOSC)

Phase 1
Completed
Conditions
Antibiotics
Subcutaneous Injection
Daptomycin
Interventions
First Posted Date
2020-06-16
Last Posted Date
2022-02-01
Lead Sponsor
University Hospital, Caen
Target Recruit Count
12
Registration Number
NCT04434300
Locations
🇫🇷

CHU Caen, Caen, Normandie, France

A Pharmacokinetics Study of Daptomycin in Critically Ill Patients and Effects of Daptomycin on Kidney

Conditions
Infection
Outcome, Fatal
Interventions
First Posted Date
2020-02-20
Last Posted Date
2020-11-13
Lead Sponsor
Zhongnan Hospital
Target Recruit Count
120
Registration Number
NCT04277143
Locations
🇨🇳

Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

Optimized Antibiotic Therapy in Patients With Subarachnoid Haemorrhage (ES) and Cerebral Haemorrhage (EC)

Conditions
Therapeutic Drug Monitoring
Subarachnoid Hemorrhage
Intracerebral Hemorrhage
First Posted Date
2019-10-18
Last Posted Date
2021-07-21
Lead Sponsor
Azienda Sanitaria-Universitaria Integrata di Udine
Target Recruit Count
104
Registration Number
NCT04132115
Locations
🇮🇹

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD, Udine, Italy

🇮🇹

Terapia Intensiva 1, Udine, Italy

Retrospective Analysis of Nephrotoxicity During Daptomycin Versus Vancomycin Treatments in High Risk Patients

Completed
Conditions
Infection Related to Vascular Prothesis
Infective Endocarditis
Infection Related to Ventricular Assist Device
Mediastinitis
Surgical Site Infection
Interventions
First Posted Date
2019-05-23
Last Posted Date
2019-05-23
Lead Sponsor
University Hospital, Montpellier
Target Recruit Count
72
Registration Number
NCT03961503
Locations
🇫🇷

Uh Montpellier, Montpellier, France

Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)

Phase 2
Completed
Conditions
Bacteremia
Soft Tissue Infections
Skin Diseases, Infectious
Interventions
First Posted Date
2018-08-23
Last Posted Date
2022-05-13
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
18
Registration Number
NCT03643952
Locations
🇯🇵

Nihon University Itabashi Hospital ( Site 0029), Tokyo, Japan

🇯🇵

Saitama City Hospital ( Site 0008), Saitama, Japan

🇯🇵

Chiba Children's Hospital ( Site 0024), Chiba, Japan

and more 13 locations

Adjunction of Daptomycin for the Treatment of Pneumococcal Meningitis

Phase 2
Completed
Conditions
Pneumococcal Meningitis
Interventions
First Posted Date
2018-03-29
Last Posted Date
2024-10-01
Lead Sponsor
Centre Hospitalier Universitaire Dijon
Target Recruit Count
112
Registration Number
NCT03480191
Locations
🇫🇷

CHU Dijon Bourgogne, Dijon, France

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