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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04298463
Study type Observational
Source Aziende Chimiche Riunite Angelini Francesco S.p.A
Contact
Status Completed
Phase
Start date June 18, 2020
Completion date May 19, 2021

See also
  Status Clinical Trial Phase
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Recruiting NCT05599295 - Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous (IV) Oritavancin Phase 2
Completed NCT03233438 - Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Phase 4
Completed NCT03873987 - Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients Phase 1
Not yet recruiting NCT04229511 - Development of Risk Score Model and Decision Tree Algorithm for Predicting Infections With CRKp in Colonized Patients