Dalbavancin

Generic Name: Dalbavancin

Brand Names: Dalvance, Xydalba

Drug Type: Small Molecule

Chemical Formula: -

CAS Number: 171500-79-1

Unique Ingredient Identifier: 808UI9MS5K

Background: 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)

Associated Therapies: -

Clinical Trials

Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Phase 4

Completed

Conditions: Acute Bacterial Skin and Skin Structure Infection
Bacterial Infections

Interventions: Drug: Usual Care
Drug: Dalbavancin

First Posted Date: 2017-07-28

Last Posted Date: 2020-01-18

Lead Sponsor: Allergan

Target Recruit Count: 91

Registration Number: NCT03233438

Locations: 🇺🇸
Weill Cornell Medicine, New York, New York, United States

Efficacy and Safety of Dalbavancin Compared to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Infective Endocarditis

Phase 2

Terminated

Conditions: Endocarditis
Bacteremia

Interventions: Drug: Standard of Care
Drug: Dalbavancin

First Posted Date: 2017-05-11

Last Posted Date: 2022-04-25

Lead Sponsor: AbbVie

Target Recruit Count: 2

Registration Number: NCT03148756

Locations: 🇺🇸
Midway Immunology and Research Center, Fort Pierce, Florida, United States

Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis

Phase 2

Terminated

Conditions: Osteomyelitis

Interventions: Drug: Standard of Care
Drug: Dalbavancin

First Posted Date: 2017-03-27

Last Posted Date: 2018-09-26

Lead Sponsor: Allergan

Target Recruit Count: 1

Registration Number: NCT03091439

Locations: 🇺🇸
Midway Immunology and Research Center, Fort Pierce, Florida, United States

Evaluation of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Phase 4

Completed

Conditions: Acute Bacterial Skin and Skin Structure Infections

Interventions: Drug: Usual Care
Drug: Dalbavancin

First Posted Date: 2016-11-11

Last Posted Date: 2020-04-10

Lead Sponsor: Allergan

Target Recruit Count: 313

Registration Number: NCT02961764

Locations: 🇺🇸
Hartford Hospital, Hartford, Connecticut, United States
🇺🇸
Johns Hopkins Hospital, Baltimore, Maryland, United States
🇺🇸
Tampa General Hospital, Tampa, Florida, United States

and more 8 locations

Evaluation of Intravenous and Intraperitoneal Pharmacokinetics of Dalbavancin in Peritoneal Dialysis Patients

Phase 4

Completed

Conditions: Infectious Peritonitis

Interventions: Drug: Dalbavancin via Intravenous Administration
Drug: Dalbavancin via Intraperitoneal Administration

First Posted Date: 2016-10-21

Last Posted Date: 2021-03-19

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 10

Registration Number: NCT02940730

Locations: 🇺🇸
University of Colorado Hospital, Aurora, Colorado, United States

Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA

Phase 3

Completed

Conditions: Bacterial Infections
Methicillin-Resistant Staphylococcus Aureus
Staphylococcal Skin Infections

Interventions: Drug: Dalbavancin
Drug: Vancomycin
Drug: Oxacillin
Drug: Flucloxacillin
Drug: Cefadroxil
Drug: Clindamycin

First Posted Date: 2016-06-28

Last Posted Date: 2024-01-17

Lead Sponsor: AbbVie

Target Recruit Count: 199

Registration Number: NCT02814916

Locations: 🇱🇹
Klaipeda Children's Hospital /ID# 235652, Klaipeda, Lithuania
🇧🇬
University Multiprofile Hospital for Active Treatment Deva Maria EOOD Burgas /ID# 235965, Bulgas, Bulgaria
🇧🇬
MHAT (Multiprofile Hospital for Active Treatment) /ID# 235539, Kozloduy, Bulgaria

and more 81 locations

Study Evaluate the PK Profile of Dalbavancin in Infants and Neonates Patients With Known or Suspected Bacterial Infection

Phase 1

Terminated

Conditions: Bacterial Infections

Interventions: Drug: Dalbavancin

First Posted Date: 2016-02-23

Last Posted Date: 2022-03-29

Lead Sponsor: AbbVie

Target Recruit Count: 8

Registration Number: NCT02688790

Locations: 🇺🇸
Children's Mercy Kansas City, Kansas City, Missouri, United States
🇺🇸
Mary Birch Hospital for Women and Newborns, San Diego, California, United States
🇺🇸
University of California, San Diego, San Diego, California, United States

and more 2 locations