Dalbavancin

Generic Name: Dalbavancin

Brand Names: Dalvance, Xydalba

Drug Type: Small Molecule

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)

Clinical Trials

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

Study on the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Participants With Osteomyelitis

Phase 2

Completed

Conditions: Osteomyelitis

Interventions: Drug: Comparator
Drug: Dalbavancin

First Posted Date: 2016-02-18

Last Posted Date: 2019-01-04

Lead Sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc

Target Recruit Count: 80

Registration Number: NCT02685033

Locations: 🇺🇦
Allergan Investigative Site 001, Cherkasy, Ukraine

Dalbavancin vs Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis

Phase 3

Withdrawn

Conditions: Osteomyelitis

Interventions: Drug: cefazolin, nafcillin, oxacillin or vancomycin
Drug: Dalbavancin

First Posted Date: 2015-01-26

Last Posted Date: 2016-09-23

Lead Sponsor: Durata Therapeutics International BV (an Affiliate of Actavis, Inc.)

Registration Number: NCT02344511

A P3 Comparator Trial in Community Acquired Bacterial Pneumonia

Phase 3

Withdrawn

Conditions: Community Acquired Pneumonia

Interventions: Drug: Linezolid Placebo
Drug: Linezolid
Drug: Dalbavancin
Drug: Azithromycin

First Posted Date: 2014-10-21

Last Posted Date: 2016-01-22

Lead Sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc

Registration Number: NCT02269644

Locations: 🇺🇸
Mercury Street Medical Group, Butte, Montana, United States

Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Phase 3

Completed

Conditions: Wound Infection
Abscess
Cellulitis
Surgical Site Infection

Interventions: Drug: Dalbavancin
Drug: Dalbavancin-matching Placebo

First Posted Date: 2014-05-01

Last Posted Date: 2018-09-28

Lead Sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc

Target Recruit Count: 698

Registration Number: NCT02127970

Locations: 🇺🇸
112, Washington, District of Columbia, United States
🇺🇸
107, Orlando, Florida, United States
🇺🇸
127, Smyrna, Tennessee, United States

and more 75 locations

A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years.

Phase 1

Completed

Conditions: Bacterial Infections.

Interventions: Drug: Dalbavancin

First Posted Date: 2013-09-19

Last Posted Date: 2015-06-23

Lead Sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc

Target Recruit Count: 36

Registration Number: NCT01946568

Locations: 🇺🇸
Connecicut Children's Hospital, Hartford, Connecticut, United States
🇺🇸
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
🇺🇸
University of Louisville, Louisville, Kentucky, United States

and more 9 locations