Retrospective Effectiveness Study of Dalbavancin and Other Standard of Care of the Same Class in … (NCT04298463) | Clinical Trial Compass
CompletedNot Applicable
Retrospective Effectiveness Study of Dalbavancin and Other Standard of Care of the Same Class in Patients With ABSSSI
Greece, Italy184 participantsStarted 2020-06-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
✕
What they're measuring
1
Time of discharge from any ward of the hospital,
Timeframe: From baseline to discharge, an average of 4 weeks
Trial details
NCT IDNCT04298463
SponsorAziende Chimiche Riunite Angelini Francesco S.p.A