Interest of the Second Phase of the Oral Challenge Test in Patients With Suspected Long-standing Penicillin Allergy (PENI)
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| ClinicalTrials.gov Identifier: NCT04513938 |
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Recruitment Status :
Active, not recruiting
First Posted : August 14, 2020
Last Update Posted : August 30, 2021
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The most common drug allergy reported is penicillin allergy, approximately 10% of the world's population. According to the latest studies, only 1-2% of them have a proven hypersensitivity to penicillins. Being wrongly labeled "allergic" leads to a loss of chance for patients to be treated with a molecule of less efficacy than penicillins, an increase in bacterial resistance by broadening the spectrum of action of the molecules prescribed as an alternative and ultimately a additional financial cost. There are several forms of hypersensitivity: the two most classic: immediate hypersensitivity (type I according to Gell and Combs) with a reaction within an hour of taking and non-immediate hypersensitivity with a reaction occurring several days later (type IV according to Gell and Combs). A large majority of patients report a history of allergy in childhood that is poorly described and most often absent from health records. In most cases, this may be a viral rash concomitant with a febrile episode mistakenly mistaken for an allergic skin reaction. Patients are then tested for several decades, in adulthood, after their initial reaction. This latency of time involves a risk of negativation of the allergic tests and it is not excluded that the skin tests or drug reintroductions re cause sensitization to the antibiotic tested and that ultimately the patient reacts when taking the future drug. In fact, it is recommended to optimally explore patients approximately 6 months after an allergic reaction (except for severe drug eruptions).
The exploration of drug hypersensitivity to penicillins therefore involves a strict questioning of the circumstances of the so-called allergic reaction allowing the reaction to be classified as immediate or delayed, then skin tests (prick test, IDR and Patch test according to the immediate profile or delayed) and finally the hospital provocation test. While provocation tests are carried out conventionally most often within one day, it has been shown that some patients react several days after taking penicillin repeatedly: 6.1% have a reaction in their protocol of taking for 5 days at home in the context of a delayed allergy.
In the allergology service at hôpital Paris Saint-Joseph, the protocol corresponds to 2 successive reintroductions.
This study is to evaluate the protocol for reintroducing Amoxicillin or Augmentin carried out over two stages: a first with 100 mg (i.e. 1 / 10th of a dose) then a second with a dose of 1200 mg 1 month later. It would be a question of seeing if with the second reintroduction, one could not catch up with allergic people who would have presented a false negative during the first reintroduction because of explorations too far away from their initial reaction.
| Condition or disease |
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| Allergy Penicillin |
| Study Type : | Observational |
| Actual Enrollment : | 195 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Interest of the Second Phase of the Oral Challenge Test in Patients With Suspected Long-standing Penicillin Allergy |
| Actual Study Start Date : | July 20, 2020 |
| Actual Primary Completion Date : | August 20, 2020 |
| Estimated Study Completion Date : | December 31, 2021 |
- Evaluation of the second oral challenge test [ Time Frame: Day 1 ]This outcome corresponds to the percentage of patients diagnosed with allergies during the second Oral Challenge Test versus all patients with a negative first Oral Challenge Test.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patient aged ≥ 18 years
- Patient with a history of drug allergy and eviction for more than 12 months of penicillins A: mainly amoxicillin and amoxicillin + clavulanic acid
- Patients who had two amoxicillin or Augmentin Oral Challenge Test between December 2017 and December 2018 in allergology department of the Paris Saint-Joseph hospital
- French-speaking patient
Exclusion Criteria:
- Patient with uncontrolled asthma
- Patient with an ongoing infection
- Patient with positive skin tests for penicillin before the first TPO
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient objecting to participation in the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04513938
| France | |
| Groupe Hospitalier Paris Saint-Joseph | |
| Paris 14, France, 75014 | |
| Principal Investigator: | GEST Noemie, MD | Groupe Hospitalier Paris Saint Joseph |
| Responsible Party: | Groupe Hospitalier Paris Saint Joseph |
| ClinicalTrials.gov Identifier: | NCT04513938 |
| Other Study ID Numbers: |
PENI |
| First Posted: | August 14, 2020 Key Record Dates |
| Last Update Posted: | August 30, 2021 |
| Last Verified: | August 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Hypersensitivity Immune System Diseases |