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

A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia

Phase 1

Recruiting

Conditions: Leukemia
Acute Myeloid Leukemia
Lymphoblastic Leukemia in Children

Interventions: Drug: Dalbavancin
Drug: Fluoroquinolone (either ciprofloxacin or levofloxacin at the discretion of the treating clinician)

First Posted Date: 2025-02-05

Last Posted Date: 2025-05-15

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 29

Registration Number: NCT06810583

Locations: 🇺🇸
St. Jude Children's Research Hospital, Memphis, Tennessee, United States

Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

Phase 4

Recruiting

Conditions: Frostbite

Interventions: Other: Aloe Vera
Device: Long-Acting silver dressings
Drug: Dalbavancin

First Posted Date: 2024-02-20

Last Posted Date: 2024-05-13

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 100

Registration Number: NCT06266494

Locations: 🇺🇸
University of Colorado Denver Anschutz Medical Campus, Aurora, Colorado, United States

Evaluation of the Efficacy and Safety of Suppressive Therapy With DALBAVANCINE in Device Infections

Completed

Conditions: Prosthesis-related Infections

First Posted Date: 2023-10-18

Last Posted Date: 2023-10-18

Lead Sponsor: Tourcoing Hospital

Target Recruit Count: 15

Registration Number: NCT06089044

Locations: 🇫🇷
CH Tourcoing, Tourcoing, France

Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus

Phase 3

Recruiting

Conditions: Catheter Bacteremia
Staphylococcus Aureus Infection

Interventions: Drug: Standard antibiotic therapy
Drug: Dalbavancin administration

First Posted Date: 2021-11-11

Last Posted Date: 2025-04-06

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 406

Registration Number: NCT05117398

Locations: 🇫🇷
Infectious Diseases Department, Raymond-Poincaré Hospital - APHP, Garches, France
🇫🇷
Infectious Diseases Department, CH PERIGUEUX, Périgueux, France

Efficacy of Dalbavancin in Osteoarticular Infections Associated With Hip and Knee Replacements

Not Applicable

Recruiting

Conditions: Osteoarticular Infection

Interventions: Drug: Dalbavancin

First Posted Date: 2021-09-16

Last Posted Date: 2024-03-13

Lead Sponsor: Centre Hospitalier Universitaire de Nice

Target Recruit Count: 43

Registration Number: NCT05046860

Locations: 🇫🇷
CHRU de TOURS, Tours, France
🇫🇷
AP-HP - Hôpital Ambroise-Paré, Boulogne-Billancourt, France
🇫🇷
Centre Hospitalier de Tourcoing, Tourcoing, France

and more 1 locations

Dalbavancin Real-life Utilization in Diabetic Patients Suffering From Infections (DALBADIA)

Completed

Conditions: Infection
Diabetes

First Posted Date: 2021-07-13

Last Posted Date: 2022-09-21

Lead Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A

Target Recruit Count: 98

Registration Number: NCT04959799

Locations: 🇮🇹
A.O.U. Pisana Presidio Ospedaliero Cisanello, Pisa, Italy
🇪🇸
Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain
🇪🇸
Hospital Universitario Virgen de las Nieves, Granada, Spain

and more 8 locations

Substance Use Disorder (SUD)-Associated Infections' Treatment With Dalbavancin ENabling OUtpatient Transition

Phase 2

Terminated

Conditions: Gram-Positive Bacterial Infections
Substance Use Disorders
Intravenous Substance Abuse
Gram-Positive Bacteraemia

Interventions: Drug: Dalbavancin

First Posted Date: 2021-04-19

Last Posted Date: 2023-10-19

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 11

Registration Number: NCT04847921

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

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

Phase 2

Completed

Conditions: Staphylococcal Bacteraemia

Interventions: Drug: Dalbavancin
Drug: Cefazolin
Drug: Daptomycin
Drug: Nafcillin
Drug: Oxacillin
Drug: Vancomycin

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

Evaluation of Intravenous Dalbavancin for Peritonitis

Terminated

Conditions: Peritonitis
Peritonitis Bacterial

First Posted Date: 2020-11-10

Last Posted Date: 2024-05-09

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 2

Registration Number: NCT04624451

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

Retrospective Effectiveness Study of Dalbavancin and Other Standard of Care of the Same Class in Patients With ABSSSI

Completed

Conditions: Acute Bacterial Skin and Skin Structure Infection

Interventions: Drug: Xydalba
Drug: vancomycin, teicoplanin or daptomycin

First Posted Date: 2020-03-06

Last Posted Date: 2022-03-04

Lead Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A

Target Recruit Count: 184

Registration Number: NCT04298463

Locations: 🇬🇷
University Hospital of Alexandroupolis, Alexandroupolis, Greece
🇬🇷
University General Hospital of Thessaloniki AHEPA /, Thessaloníki, Greece
🇬🇷
University Hospital of Heraklion, Heraklion, Greece

and more 13 locations

Drug Development Updates

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