About the project
Around 10% of the population have a diagnosis of penicillin allergy - but more than 90% of these patients tolerate penicillin antibiotics. The predominantly inaccurate diagnosis of penicillin allergies means that fewer suitable antibiotics are used. This leads to poorer treatment outcomes, longer hospital stays and promotes antibiotic resistance.
PENGUIN is a multi-centre observational study at German university hospitals. It investigates how a suspected penicillin allergy can be safely verified and refuted and, if necessary, removed from the patient's medical records (this is known as "delabelling"). The aim of the study is to improve the treatment of patients, reduce antibiotic resistance and improve the quality of life of those affected.
The most important facts at a glance
The PENGUIN project is investigating whether so-called "second-line antibiotics" are used less frequently if the diagnosis of "penicillin allergy" is refuted. These drugs are often used when patients have a penicillin allergy in their medical records, but are often less effective or have more side effects. However, it often turns out that there is no real allergy at all. By safely checking and, if necessary, removing this allergy entry ("delabelling"), penicillin antibiotics can be used more frequently again. This should improve treatment and avoid unnecessary or inappropriate antibiotics.
The study also investigates
Safety & coverage - What proportion of patients can be safely delabelled using a modified algorithm (ZSB score)?
Therapy optimisation - Does delabelling lead to more frequent use of targeted narrow-spectrum penicillins and more appropriate antibiotic therapy overall?
Sustainability - How many patients are still considered delabelled after 90 days?
Quality of life - Does penicillin allergy delabelling lead to an improvement in the quality of life of study participants?
The aim of "penicillin allergy delabelling" is to reliably refute false allergy diagnoses and thus improve antibiotic treatment. It is particularly important that patients are well protected and informed and that hospital staff are trained accordingly. In addition, different processes in the clinics must be taken into account and the changes reliably documented. PENGUIN is systematically analysing how these challenges can be solved in everyday clinical practice.
PENGUIN is a multi-centre (multi-site) single-arm observational study being conducted at 12 sites across Germany. A "single-arm observational study" is a scientific study in which all participants receive the same treatment or examination. There is therefore no comparison group with a different treatment or without treatment. "Observational study" also means that the researchers primarily observe and document what happens in the normal course of treatment.
During the development of the study, the perspectives of those affected and patient advocates were actively taken into account and included in the study planning. The participating centres already have established local guidelines for risk stratification (assessment and classification of risks) for penicillin allergy. PENGUIN builds on this existing expertise and creates a common, comparable database.