Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04513938
Status:
COMPLETED
Last Update Posted:
2023-04-27
First Post:
2020-08-12
Brief Title:
Interest of the Second Phase of the Oral Challenge Test in Patients With Suspected Long-standing Penicillin Allergy
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Fondation Hôpital Saint-Joseph
Study Overview
Official Title:
Interest of the Second Phase of the Oral Challenge Test in Patients With Suspected Long-standing Penicillin Allergy
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PENI
Brief Summary:
The most common drug allergy reported is penicillin allergy approximately 10 of the worlds 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 61 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 ie 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
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 61 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 ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None