Status:
COMPLETED
Retrospective Effectiveness Study of Dalbavancin and Other Standard of Care of the Same Class in Patients With ABSSSI
Lead Sponsor:
Aziende Chimiche Riunite Angelini Francesco S.p.A
Collaborating Sponsors:
Hippocrates Research
Conditions:
Acute Bacterial Skin and Skin Structure Infection
Eligibility:
All Genders
18+ years
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 an...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 19 2021
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT04298463
Start Date
June 18 2020
End Date
May 19 2021
Last Update
March 4 2022
Active Locations (16)
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1
University Hospital of Alexandroupolis
Alexandroupoli, 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 /
Thessaloniki, Greece, 54621