Oritavancin

Generic Name
Oritavancin
Brand Names
Kimyrsa, Orbactiv, Tenkasi (previously Orbactiv)
Drug Type
Small Molecule
Chemical Formula
C86H97Cl3N10O26
CAS Number
171099-57-3
Unique Ingredient Identifier
PUG62FRZ2E
Background

Oritavancin is a glycopeptide antibiotic used for the treatment of skin infections. It was developed by The Medicines Company (acquired by Novartis). Oritavancin was initially approved by the FDA in 2014 and formulated to combat susceptible gram-positive bacteria that cause skin and skin structure infections. It boasts the option of single-dose administratio...

Indication

用于治疗由下列易感分离株革兰氏阳性微生物所致急性细菌皮肤和皮肤结构感染(ABSSSI)成年患者的治疗。如金黄色葡萄球菌(包括甲氧西林-易感和甲氧西林–耐药分离株),化脓性链球菌,无乳链球菌,停乳链球菌,咽峡炎链球菌群(包括咽颊炎链球菌,中间型链球菌,和星座链球菌),和粪肠球菌(万古霉素-仅易感分离株)。

Associated Conditions
Skin and skin structure infections
Associated Therapies
-

Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous (IV) Oritavancin

First Posted Date
2022-10-31
Last Posted Date
2024-07-29
Lead Sponsor
Melinta Therapeutics, LLC
Target Recruit Count
200
Registration Number
NCT05599295
Locations
🇧🇬

University Multiprofile Hospital For Active Treatment Kanev AD, Ruse, Bulgaria

🇷🇴

Louis Turcanu Emergency Clinical Hospital for Children, Timisoara, Timis, Romania

🇵🇹

Hospital de Braga, Braga, Portugal

and more 26 locations

Anchoring Sequential Intermittent Long Acting Antimicrobials With Medication for Opioid Use Disorder (MOUD) for Invasive Infections Related to Opioid Use

First Posted Date
2022-08-30
Last Posted Date
2024-11-05
Lead Sponsor
University of Maryland, Baltimore
Target Recruit Count
25
Registration Number
NCT05521880
Locations
🇺🇸

University of Maryland Medical Center, Baltimore, Maryland, United States

Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients

First Posted Date
2019-03-14
Last Posted Date
2021-04-13
Lead Sponsor
Melinta Therapeutics, Inc.
Target Recruit Count
102
Registration Number
NCT03873987
Locations
🇺🇸

ML-ORI-102 Study Site, Somers Point, New Jersey, United States

A Retrospective Observational Study to Evaluate the Utilization, Outcomes, and Adverse Events in Participants Treated With Orbactiv® (Oritavancin) for Infections Caused by Gram Positive Bacteria in a Real World Setting

First Posted Date
2017-05-18
Last Posted Date
2018-03-12
Lead Sponsor
Melinta Therapeutics, Inc.
Target Recruit Count
325
Registration Number
NCT03159403
Locations
🇺🇸

Birmingham Infectious Disease and Infusion, Birmingham, Alabama, United States

🇺🇸

St. Vincent Hospital and Health Care Center, Inc., Indianapolis, Indiana, United States

🇺🇸

Santa Barbara Cottage Hospital, Santa Barbara, California, United States

and more 18 locations

Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacterial Skin and Skin Structure Infection

First Posted Date
2016-10-05
Last Posted Date
2024-02-01
Lead Sponsor
The Medicines Company
Target Recruit Count
22
Registration Number
NCT02925416
Locations
🇺🇸

South Jersey Infectious Disease, Somers Point, New Jersey, United States

Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-06-15
Last Posted Date
2023-12-19
Lead Sponsor
The Medicines Company
Target Recruit Count
56
Registration Number
NCT02471690
Locations
🇺🇸

Spaulding Clinical, West Bend, Wisconsin, United States

Multiple Oritavancin Doses on Safety, Tolerability, and Pharmacokinetics in Healthy Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-06-12
Last Posted Date
2023-12-19
Lead Sponsor
Melinta Therapeutics, Inc.
Target Recruit Count
14
Registration Number
NCT02470702

Oritavancin on the Results of Multiple Coagulation Tests in Healthy Volunteers

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-02-06
Last Posted Date
2023-12-19
Lead Sponsor
Melinta Therapeutics, Inc.
Target Recruit Count
20
Registration Number
NCT02357524

Open-Label, Dose-Finding, Pharmacokinetics, Safety and Tolerability Study of Oritavancin in Pediatric Patients With Suspected or Confirmed Bacterial Infections

Phase 1
Recruiting
Conditions
Interventions
First Posted Date
2014-05-09
Last Posted Date
2024-03-04
Lead Sponsor
Melinta Therapeutics, LLC
Target Recruit Count
52
Registration Number
NCT02134301
Locations
🇺🇸

Rainbow Babies and Children's Hospital, Cleveland, Ohio, United States

🇺🇸

UCLA Harbor Medical Center, Torrance, California, United States

🇺🇸

Stony Brook University Medical Center, Stony Brook, New York, United States

and more 6 locations
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