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

Sponsor

Aziende Chimiche Riunite Angelini Francesco S.p.A (Industry)

Overall Status

Completed

CT.gov ID

NCT04298463

Collaborator

Hippocrates Research (Other)

184

Enrollment

Locations

Actual Duration (Months)

11.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Bacterial Skin and Skin Structure Infection	Drug: Xydalba Drug: vancomycin, teicoplanin or daptomycin

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.

Study Design

Study Type:

Observational

Actual Enrollment :

184 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Jun 18, 2020

Actual Primary Completion Date :

May 19, 2021

Actual Study Completion Date :

May 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
COHORT A: dalbavancin Patients hospitalized for at teast two days affected by ABSSSI and treated with dalbavancin.	Drug: Xydalba Drugs were administered i.v.
COHORT B: lipo and glyco-peptid drugs Patients hospitalized for at teast two days affected by ABSSSI and treated with vancomycin, teicoplanin or daptomycin.	Drug: vancomycin, teicoplanin or daptomycin Drugs were administered i.v.

Arm

Intervention/Treatment

COHORT A: dalbavancin

Patients hospitalized for at teast two days affected by ABSSSI and treated with dalbavancin.

Drug: Xydalba

Drugs were administered i.v.

COHORT B: lipo and glyco-peptid drugs

Patients hospitalized for at teast two days affected by ABSSSI and treated with vancomycin, teicoplanin or daptomycin.

Drug: vancomycin, teicoplanin or daptomycin

Drugs were administered i.v.

Outcome Measures

Primary Outcome Measures

Time of discharge from any ward of the hospital, [From baseline to discharge, an average of 4 weeks]
Time of discharge is calculated as the time elapsed from the beginning of antibiotic therapy (baseline) until discharge.

Secondary Outcome Measures

Evaluation of the recorded signs and symptoms [From the hospital admission until 30 days from discharge]
Evaluation of local signs of inflammation.
Microbiological evaluation [From the hospital admission until 30 days from discharge]
Eradication of the Gram Positive pathogens identified at baseline (MIC assessment)
Long-term follow-up [90 days from discharge]
Assessment for recurrence of ABSSSI.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male and female patients ≥ of 18 years old
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.
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).
Patients treated with or without other chemotherapy to cover Gram- bacteria or fungals.
Patients who gave their consent for personal data processing according to the local regulation.

Exclusion Criteria:

Patients with infected wound or ulcer (neoplastic, inflammatory and autoimmune ulcers), animal bite
Patients with ulcer not colonized, discolored, odorous, pressure ulcer grade I, II, III, or IV (according to NPUAP classification - Appendix A)
Patients with arteriopathies
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)

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	University Hospital of Alexandroupolis	Alexandroupolis	Greece	68100
2	Attikon University Hospital, Rimini 1, Chaidari, 124 62	Athens	Greece	12462
3	University Hospital of Heraklion	Heraklion	Greece	71110
4	University General Hospital of Thessaloniki AHEPA /	Thessaloníki	Greece	54621
5	AO Sant'Orsola Malpighi Unità Operativa di Malattie Infettive	Bologna	Italy	40138
6	Azienda Ospedaliera per l'Emergenza Cannizzaro Unità Operativa Complessa di Malattie Infettive	Catania	Italy	95126
7	A.O.U. Careggi SOD Malattie Infettive e Tropicali	Firenze	Italy	50134
8	Ospedale Policlinico San Martino - IRCCS Genova Clinica Malattie Infettive	Genova	Italy	16132
9	ASST MANTOVA Ospedale Carlo Poma di Mantova S.C. Malattie Infettive	Mantova	Italy	46100
10	A.S.S.T. GRANDE OSPEDALE METROPOLITANO NIGUARDA S.C. Malattie Infettive Dipartimento Medico Polispecialistico	Milan	Italy	20162
11	AOU Federico II di Napoli Dipartimento di Medicina clinica e Chirurgia UOC Malattie Infettive	Napoli	Italy	80131
12	Azienda Ospedaliera di Padova U.O.C. Malattie Infettive e Tropicali	Padova	Italy	35128
13	Ospedale S. Maria della Misericordia Clinica Malattie Infettive Dipartimento di Medicina, Università Studi di Perugia	Perugia	Italy	06156
14	A.O.U. Pisana Stabilimento di Cisanello U.O Malattie Infettive	Pisa	Italy	56124
15	A.O.R. San Carlo Struttura Interaziendale Complessa di Malattie Infettive	Potenza	Italy	85100
16	AOU Città della Salute e Scienza - Presidio Molinette SC Malattie Infettive	Torino	Italy	10126