Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00363688
Status:
TERMINATED
Last Update Posted:
2006-08-15
First Post:
2006-08-10
Brief Title:
Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin
Sponsor:
Meir Medical Center
Organization:
Meir Medical Center
Study Overview
Official Title:
Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin Is It Safe
Status:
TERMINATED
Status Verified Date:
1997-12
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:
None
Brief Summary:
The purpose of this study is to examine whether oral challenge with penicillin for patients with a known history of non-life threatening allergic reaction to penicillin is well-tolerated irrespective of skin-testing results
Detailed Description:
Objective To examine whether oral challenge with penicillin for patients with a known history of non-life threatening allergic reaction to penicillin is well-tolerated irrespective of skin-testing results long after the event occurred
Methods In this prospective open-label controlled multi-clinical trial 8702 individuals from primary care clinics were screened for penicillin allergy 169 patients with a history of non-life threatening allergic reaction to penicillin dating back at least 3 years were recruited for study Regardless of the response to penicillin skin testing patients received the recommended daily dosage of penicillin and amoxicillin on two separate occasions 2-6 years later a follow-up was conducted to assess the outcomes of further penicillin administration
Results 929 of the patients had an allergic reaction 6 years or longer before enrollment in the study Of 272 challenges 137 were skin-test positive with mild rash in 9 patients 66 and 135 were skin-test negative with similar allergic reaction in 5 37 P 29 At follow-up 3 of 55 patients 55 who were given a full treatment course of penicillin developed mild skin eruption
Conclusions A positive penicillin skin testing of patients with a history of non-life threatening allergic reaction to penicillin occurring 3 years or longer from the event was not associated with a greater prevalence of adverse reactions to oral challenge with penicillin than a negative one It is of importance to determine whether oral challenge can serve as a diagnostic procedure for this particular group of patients thereby saving the need for prior penicillin skin testing
Methods In this prospective open-label controlled multi-clinical trial 8702 individuals from primary care clinics were screened for penicillin allergy 169 patients with a history of non-life threatening allergic reaction to penicillin dating back at least 3 years were recruited for study Regardless of the response to penicillin skin testing patients received the recommended daily dosage of penicillin and amoxicillin on two separate occasions 2-6 years later a follow-up was conducted to assess the outcomes of further penicillin administration
Results 929 of the patients had an allergic reaction 6 years or longer before enrollment in the study Of 272 challenges 137 were skin-test positive with mild rash in 9 patients 66 and 135 were skin-test negative with similar allergic reaction in 5 37 P 29 At follow-up 3 of 55 patients 55 who were given a full treatment course of penicillin developed mild skin eruption
Conclusions A positive penicillin skin testing of patients with a history of non-life threatening allergic reaction to penicillin occurring 3 years or longer from the event was not associated with a greater prevalence of adverse reactions to oral challenge with penicillin than a negative one It is of importance to determine whether oral challenge can serve as a diagnostic procedure for this particular group of patients thereby saving the need for prior penicillin skin testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None