Z88.0
Conditions
Interventions
Group 1: PENGUIN is a multicenter, prospective observational study examining the use of a standardized algorithm and its impact in the context of routine clinical care. A total of 12 study sites are p
patients serve as their own controls by having their antibiotic therapy evaluated before and after delabeling. This is a quantitative study.
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients with a history of penicillin allergy - Current antibiotic therapy - Planned inpatient treatment lasting more than 24 hours
Exclusion criteria
Exclusion criteria: - Under 18 years of age - Pregnancy - Use of antihistamines within the past 24 hours, or current use of corticosteroids at a dose exceeding 10 mg of prednisolone equivalent, or ongoing treatment with omalizumab - Mastocytosis - Idiopathic anaphylaxis/urticaria - Current stay in the intensive care unit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the reduction in the use of second-line antibiotics before and after PA delabeling in hospitalized patients. This primary endpoint is derived from electronic or paper-based medication plans at the time points specified in the study protocol, with the types of antibiotics prescribed before and after delabeling being documented. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints include the proportion of patients who were delisted (coded as delisted yes/no), the use of penicillin (coded as yes/no), the appropriateness of antibiotic therapy (coded as yes/no), as well as quality of life, measured by the score of the validated DrHy-Q6 questionnaire and EQ-5D-5L before and after delabeling. In addition, the study examines whether the “penicillin allergy” label is reassigned within 90 days (coded as yes/no) and whether a positive allergic reaction occurred after delabeling (coded as yes/no). Barriers and facilitating factors (structural, psychological, emotional) that prevent or support delabeling are not statistically analyzed but are described descriptively. Exploratory endpoints include length of hospital stay (measured in days), duration of antibiotic therapy (measured in days), readmission to the hospital (coded as yes/no), adverse drug reactions, e.g., C. difficile infections, deterioration of renal function due to glycopeptide therapy (evaluated descriptively), and mortality at day 90 (coded as yes/no). | — |
Countries
Germany
Contacts
Public ContactElham Khatamzas
Universitäsklinikum Heidelberg
Outcome results
None listed