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

NCT04298463 | Completed

• 1 other identifier: 146(A)PO18530
• Study Type: observational
• Target: 184
• Locations: 2 countries
• Sites: 16

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.

Conditions

Acute Bacterial Skin and Skin Structure Infection

Keywords

ABSSSI; skin infections; lipoglycopeptide,; Gram-positive bacteria

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluation of the recorded signs and symptoms

  From the hospital admission until 30 days from discharge

• Microbiological evaluation

  From the hospital admission until 30 days from discharge

• Long-term follow-up

  90 days from discharge

Study Arms (2)

COHORT A: dalbavancin

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

Drug: Xydalba

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

Interventions

Xydalba DRUG

Drugs were administered i.v.

COHORT A: dalbavancin

vancomycin, teicoplanin or daptomycin DRUG

Drugs were administered i.v.

COHORT B: lipo and glyco-peptid drugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients hospitalized for at least 2 days with evidence of primary diagnosis of ABSSSI and treated with dalbavancin or other SoC of similar class (i.v lipo and glycopeptides vancomycin, teicoplanin or daptomycin).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead
• Hippocrates Research: collaborator

Study Sites (16)

University Hospital of Alexandroupolis

Alexandroupoli, 68100, Greece

Location

Attikon University Hospital, Rimini 1, Chaidari, 124 62

Athens, 12462, Greece

Location

University Hospital of Heraklion

Heraklion, 71110, Greece

Location

University General Hospital of Thessaloniki AHEPA /

Thessaloniki, 54621, Greece

Location

AO Sant'Orsola Malpighi Unità Operativa di Malattie Infettive

Bologna, 40138, Italy

Location

Azienda Ospedaliera per l'Emergenza Cannizzaro Unità Operativa Complessa di Malattie Infettive

Catania, 95126, Italy

Location

A.O.U. Careggi SOD Malattie Infettive e Tropicali

Florence, 50134, Italy

Location

Ospedale Policlinico San Martino - IRCCS Genova Clinica Malattie Infettive

Genova, 16132, Italy

Location

ASST MANTOVA Ospedale Carlo Poma di Mantova S.C. Malattie Infettive

Mantova, 46100, Italy

Location

A.S.S.T. GRANDE OSPEDALE METROPOLITANO NIGUARDA S.C. Malattie Infettive Dipartimento Medico Polispecialistico

Milan, 20162, Italy

Location

AOU Federico II di Napoli Dipartimento di Medicina clinica e Chirurgia UOC Malattie Infettive

Napoli, 80131, Italy

Location

Azienda Ospedaliera di Padova U.O.C. Malattie Infettive e Tropicali

Padua, 35128, Italy

Location

Ospedale S. Maria della Misericordia Clinica Malattie Infettive Dipartimento di Medicina, Università Studi di Perugia

Perugia, 06156, Italy

Location

A.O.U. Pisana Stabilimento di Cisanello U.O Malattie Infettive

Pisa, 56124, Italy

Location

A.O.R. San Carlo Struttura Interaziendale Complessa di Malattie Infettive

Potenza, 85100, Italy

Location

AOU Città della Salute e Scienza - Presidio Molinette SC Malattie Infettive

Torino, 10126, Italy

Location

MeSH Terms

Conditions

Cellulitis

Interventions

dalbavancin; Vancomycin; Teicoplanin; Daptomycin

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Lipoglycopeptides; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: March 6, 2020
• Study Start: June 18, 2020
• Primary Completion: May 19, 2021
• Study Completion: May 19, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-02

Locations

IT (12); GR (4)