Dalbavancin

Overview

Dalbavancin is a second-generation lipoglycopeptide antibiotic that was designed to improve on the natural glycopeptides currently available, such as vancomycin and teicoplanin . Modifications from these older glycoprotein classes facilitated a similar mechanism of action for dalbavancin but with increased activity and once-weekly dosing . Its use is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), S. pyogenes, S. agalactiae, S. dysgalactiae, the S. anginosus group (including S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin susceptible strains) . Dalbavancin acts by interfering with bacterial cell wall synthesis by binding to the D-alanyl-D-alanine terminus of nascent cell wall peptidoglycan and preventing cross-linking .

Indication

适用于治疗由革兰氏阳性菌（包括耐甲氧西林金黄色葡萄球菌，MRSA）导致的急性细菌性皮肤和皮肤结构感染（ABSSSI）。

Associated Conditions

Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia	2025/02/05	NCT06810583	Phase 1	Recruiting	St. Jude Children's Research Hospital
Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis	2024/02/20	NCT06266494	Phase 4	Recruiting	University of Colorado, Denver
Evaluation of the Efficacy and Safety of Suppressive Therapy With DALBAVANCINE in Device Infections	2023/10/18	NCT06089044	N/A	Completed	Tourcoing Hospital
Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus	2021/11/11	NCT05117398	Phase 3	Recruiting	Assistance Publique - Hôpitaux de Paris
Efficacy of Dalbavancin in Osteoarticular Infections Associated With Hip and Knee Replacements	2021/09/16	NCT05046860	Not Applicable	Recruiting	Centre Hospitalier Universitaire de Nice
Dalbavancin Real-life Utilization in Diabetic Patients Suffering From Infections (DALBADIA)	2021/07/13	NCT04959799	N/A	Completed	Aziende Chimiche Riunite Angelini Francesco S.p.A
Substance Use Disorder (SUD)-Associated Infections' Treatment With Dalbavancin ENabling OUtpatient Transition	2021/04/19	NCT04847921	Phase 2	Terminated	University of Colorado, Denver
DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia	2021/03/01	NCT04775953	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
Evaluation of Intravenous Dalbavancin for Peritonitis	2020/11/10	NCT04624451	N/A	Terminated	University of Colorado, Denver
Retrospective Effectiveness Study of Dalbavancin and Other Standard of Care of the Same Class in Patients With ABSSSI	2020/03/06	NCT04298463	N/A	Completed	Aziende Chimiche Riunite Angelini Francesco S.p.A

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
DALVANCE	Allergan, Inc.	57970-100	INTRAVENOUS	500 mg in 25 mL	2/16/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Xydalba	AbbVie Deutschland GmbH & Co. KG,Knollstrasse,67061 Ludwigshafen,Germany	Authorised	2/19/2015

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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