An interventional study of Direct Oral challenge and standard of care in Penicillin Allergy, Hypersensitivity, Immediate and Hypersensitivity, Delayed, sponsored by Deniz Göcebe. Recruiting at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by Deniz Göcebe · Not applicable, Interventional, and Diagnostic
The aim of this clinical trial is to analyze the negative predictive capacity and safety of risk-stratified direct drug provocation tests for patients with self-reported penicillin allergies. Patients reporting immediate or delayed penicillin allergies and defined as low-risk by the PEN-FAST score will receive drug provocation tests without prior skin testing.
The PEN-FAST clinical decision rule is an internationally validated scoring system (0-5 points) that identifies low-risk patients (= a score of 0-2 points) with self-reported penicillin allergies with a negative predictive value (NPV) of over 95%. Performing direct drug provocation tests without prior skin testing on these low-risk patients was shown to be non-inferior in terms of safety and prediction of immediate allergic reactions. However, several studies have questioned the negative predictive capacity of the PEN-FAST score. In these studies, misclassifications of the PEN-FAST score were mainly based on positive skin test findings that can show false-positive results.
This study aims to validate the NPV and safety of direct drug provocation tests using the PEN-FAST score.
Participants with a PEN-FAST score of 0-2 points will directly receive a two-dose challenge (50%-50%) or single challenge (100%) with the culprit penicillin and will be monitored for at least 4 hours. No skin tests will be performed prior to the drug provocation test. Patients will be instructed to contact the hospital after the drug provocation test to monitor any delayed allergic reactions.
The outcomes will be compared to those of patients with a PEN-FAST score of 0-2 points who do not wish to skip the skin tests and who will, in parallel, receive the standard-of-care testing.
Currently, this study is approved as a single-site study.
82 studies on the registry are indexed under Hypersensitivity, Immediate; 7 are open to participants now.
This study's planned enrollment of 100 is above the median of 70 across 66 interventional studies indexed under Hypersensitivity, Immediate.
Browse Hypersensitivity, Immediate studies →This is the only study on the registry with Deniz Göcebe as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Direct Oral challenge
Standard of care Skin testing and measurement of allergen-specific IgE, if negative, drug provocation test.
Other: standard of care
Patients will receive a 1-step or 2-step challenge with the suspected penicillin and will be monitored for any allergic reaction within the first four hours. Patients will be instructed to contact the hospital after the drug provocation test to inquire delayed allergic reactions.
The patient will receive skin prick test and patch test (if a delayed allergy is suspected). Allergen-specific IgE will be measured. If all negative, drug provocation tets will be performed identical to the experimental group.
The difference in the proportion of patients with any positive finding in skin tests, allergen-specific IgE or drug provocation test between the two groups
Percentage of subjects that retain their allergy label as they show at least one positive finding in skin tests, allergen-specific IgE or drug provocation test.
Time frame: 7 days
Negative predictive capacity of skin tests and allergen-specific IgE
Negative predictive values of each test alone and combined
Time frame: 7 days
Analysis of medical and allergic history
(supposed) allergic symptoms
Time frame: 1 day
Penicillin allergy label
Identification of culprit penicillin
Time frame: 1 day
Analysis of demographic data
Age, sex
Time frame: 1 day
Analysis of adverse reactions
Detailed analysis of any (supposed) allergic reactions following drug provocation test
Time frame: 7 days
Analysis of medical and allergic history
year of (supposed) allergic reaction
Time frame: One day
Analysis of medical and allergic history
time between administration and (supposed) allergic reaction
Time frame: One day
Analysis of medical and allergic history
treatment required for (supposed) allergic reaction
Time frame: One day
Analysis of medical and allergic history
current medication
Time frame: One day
Analysis of internal hospital risk stratification system
Measurement of score of internal hospital risk stratification system
Time frame: One day
Analysis of medical and allergic history
(supposed) allergic symptoms
Time frame: One day
Plan to share: Yes — Individual participant data that underlie the results reported in the article that is planned to be published, after deidentification.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 3 months and ending 5 years following article publication.
Access criteria: Researchers who offer a well-structured and scientifically sound approach to realizing the objectives detailed in the approved proposal.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2026, 23 months after the start.
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