NCT04298463

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

Retrospective Effectiveness Study of Dalbavancin and Other Standard of Care of the Same Class (i.v. Lipo and Glyco-peptides) in Patients With ABSSSI

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 184 (actual)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to collect the data on the effectiveness of dalbavancin in terms of save of hospitalization days on patients treated between June 2017 and June 2019 in two countries (Italy and Greece) vs the other Standards of care of the same class (SoC; i.v. lipo and glycopeptides) in a real-life context. Time to discharge from the start of therapy for ABSSSI in the hospital context will be assessed and all relevant data available on patient management, clinical, microbiological and safety outcomes during hospitalization and in the follow-up visits up to 30 days from discharge will be collected and evaluated.

Detailed description

Acute bacterial skin and skin structure infections (ABSSSI), formally referred to as complicated skin and soft tissue infections, include infections such as cellulitis/erysipelas, wound infection, and major cutaneous abscess and have a minimum lesion surface area of approximately 75 cm2. The regulatory definitions of major abscess, cellulitis, and wound infection may not align with practice-based criteria. Common bacterial pathogens causing ABSSSI are Streptococcus pyogenes and Staphylococcus aureus including Methicillin-Resistant Staphylococcus Aureus (MRSA). Less common causes include other Streptococcus species, Enterococcus faecalis, or Gram-negative bacteria. Increasing dramatically in incidence, a challenging medical problem associated with high direct and indirect costs has been highlighted for both the medical system and society. Over the last decade, there was a witnessed a dramatic increase in the incidence of community acquired skin infections, an increasing proportion of which are a consequence of MRSA, reinforcing the need for new and effective antibacterial therapies in this disease. In this context, research has been promoted to develop new antibiotics capable to fight MRSA, the most common multi-drug-resistant Gram+ bacterium in Europe, and to overcome the limitations of the most widely used antibiotics, such as vancomycin, teicoplanin, and β- lactams. These new antibiotics (lipoglycopeptides and new oxazolidinones) have innovative characteristics that make them interesting for the specific treatment of ABSSSIs. Dalbavancin is one of these new antibiotics. Dalbavancin is a lipoglycopeptide with activity against Grampositive organisms, including MRSA, through interference with bacterial cell wall formation by preventing cross-linking of peptidoglycans. Dalbavancin has a distinctive pharmacokinetic profile, with a terminal half-life of 14.4 days, which allows for infrequent or even single intravenous dosing. This new long-acting antibiotic represents a potential opportunity for early discharge. This approach could profoundly modify the management of these infections by reducing or in some cases eliminating hospitalization costs and risks.

Conditions

• Acute Bacterial Skin and Skin Structure Infection

Interventions

Type	Name	Description
DRUG	Xydalba	Drugs were administered i.v.
DRUG	vancomycin, teicoplanin or daptomycin	Drugs were administered i.v.

Timeline

• Start date: 2020-06-18
• Primary completion: 2021-05-19
• Completion: 2021-05-19
• First posted: 2020-03-06
• Last updated: 2022-03-04

Locations

16 sites across 2 countries: Greece, Italy