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

Acute Bacterial Skin and Skin Structure Infection Clinical Trial

— REDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04298463
• Other study ID #: 146(A)PO18530
• Status: Completed
• Start date: June 18, 2020
• Est. completion date: May 19, 2021

Study information

• Verified date: February 2022
• Source: Aziende Chimiche Riunite Angelini Francesco S.p.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: May 19, 2021
• Est. primary completion date: May 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male and female patients = of 18 years old

2. Patients hospitalized for at least 2 days with evidence of primary diagnosis of ABSSSI of International Classification of Diseases (ICD) 9: - 681.XX (cellulitis and abscess of finger and toe) -682.XX (other cellulitis and abscess) - 958.3X (post-traumatic wound infection not elsewhere classified) - 998.5X (postoperative infection not elsewhere classified); and corresponding code for ICD 10; and/or Diagnosis-related group (DRG) 277; 278; 418 (for Italy), for cellulitis/erysipelas, wound infection, major cutaneous abscess.

3. Patients treated with dalbavancin or other SoC of the same or similar class (i.v. lipo and glycopeptides: teicoplanin, vancomycin, daptomycin) according to summary of product characteristics (SmPC).

4. Patients treated with or without other chemotherapy to cover Gram- bacteria or fungals.

5. Patients who gave their consent for personal data processing according to the local regulation.

Exclusion Criteria:

1. Patients with infected wound or ulcer (neoplastic, inflammatory and autoimmune ulcers), animal bite

2. Patients with ulcer not colonized, discolored, odorous, pressure ulcer grade I, II, III, or IV (according to NPUAP classification - Appendix A)

3. Patients with arteriopathies

4. Patients presenting or who have presented in the last 30 days before the

hospitalization the following infections:

• diabetic foot infection (ICD9= 707.15; 249.8)
• suspected or confirmed osteomyelitis (ICD9= 730.xx)
• suspected or confirmed septic arthritis (ICD9= 711.00)
• infective endocarditis (ICD9=421.0)
• meningitis (ICD9=322.xx)
• joint infection (ICD9= 711.00)
• necrotizing fasciitis (ICD9=728.86)
• gangrene (ICD9=785.4)
• prosthetic joint infection or prosthetic implant/device infection (ICD9=996.66)

5. Patient with history of neutropenia or in treatment with immunosuppressants in the last six months before the hospitalization

Related Conditions & MeSH terms

• Acute Bacterial Skin and Skin Structure Infection
• Infections
• Skin Diseases, Bacterial

Intervention

Drug:
• Xydalba
Drugs were administered i.v.
• vancomycin, teicoplanin or daptomycin
Drugs were administered i.v.

Locations

Country	Name	City	State
Greece	University Hospital of Alexandroupolis	Alexandroupolis
Greece	Attikon University Hospital, Rimini 1, Chaidari, 124 62	Athens
Greece	University Hospital of Heraklion	Heraklion
Greece	University General Hospital of Thessaloniki AHEPA /	Thessaloníki
Italy	AO Sant'Orsola Malpighi Unità Operativa di Malattie Infettive	Bologna
Italy	Azienda Ospedaliera per l'Emergenza Cannizzaro Unità Operativa Complessa di Malattie Infettive	Catania
Italy	A.O.U. Careggi SOD Malattie Infettive e Tropicali	Firenze
Italy	Ospedale Policlinico San Martino - IRCCS Genova Clinica Malattie Infettive	Genova
Italy	ASST MANTOVA Ospedale Carlo Poma di Mantova S.C. Malattie Infettive	Mantova
Italy	A.S.S.T. GRANDE OSPEDALE METROPOLITANO NIGUARDA S.C. Malattie Infettive Dipartimento Medico Polispecialistico	Milan
Italy	AOU Federico II di Napoli Dipartimento di Medicina clinica e Chirurgia UOC Malattie Infettive	Napoli
Italy	Azienda Ospedaliera di Padova U.O.C. Malattie Infettive e Tropicali	Padova
Italy	Ospedale S. Maria della Misericordia Clinica Malattie Infettive Dipartimento di Medicina, Università Studi di Perugia	Perugia
Italy	A.O.U. Pisana Stabilimento di Cisanello U.O Malattie Infettive	Pisa
Italy	A.O.R. San Carlo Struttura Interaziendale Complessa di Malattie Infettive	Potenza
Italy	AOU Città della Salute e Scienza - Presidio Molinette SC Malattie Infettive	Torino

Sponsors (2)

Lead Sponsor	Collaborator
Aziende Chimiche Riunite Angelini Francesco S.p.A	Hippocrates Research

Countries where clinical trial is conducted

Greece,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of discharge from any ward of the hospital,	Time of discharge is calculated as the time elapsed from the beginning of antibiotic therapy (baseline) until discharge.	From baseline to discharge, an average of 4 weeks
Secondary	Evaluation of the recorded signs and symptoms	Evaluation of local signs of inflammation.	From the hospital admission until 30 days from discharge
Secondary	Microbiological evaluation	Eradication of the Gram Positive pathogens identified at baseline (MIC assessment)	From the hospital admission until 30 days from discharge
Secondary	Long-term follow-up	Assessment for recurrence of ABSSSI.	90 days from discharge