Back to resultsThe Frequency of Positive Challenge Test to Penicillin in Children Suspected to Have Allergy to Penicillin
Primary Purpose
Penicillin Allergy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
penicillin test
Sponsored by
About this trial
This is an interventional diagnostic trial for Penicillin Allergy
Eligibility Criteria
Inclusion Criteria:
- Children older then 6 month with suspected penicillin allergy
Exclusion Criteria:
- Children under 6 month old
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
penicillin test and challenge
Outcomes
Primary Outcome Measures
The incidence of reactions during penicillin challenge tests among children with suspected penicillin allergy
To find out how many children are actually true allergic to penicillin
Secondary Outcome Measures
Full Information
NCT ID
NCT02702349
First Posted
March 3, 2016
Last Updated
March 7, 2016
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02702349
Brief Title
The Frequency of Positive Challenge Test to Penicillin in Children Suspected to Have Allergy to Penicillin
Official Title
The Frequency of Positive Challenge Test to Penicillin in Children Suspected to Have Allergy to Penicillin
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The incidence of reactions during penicillin challenge tests among children with suspected penicillin allergy
Detailed Description
children who are suspected to have penicillin allergy due to a suspected allergic reaction during penicillin treatment are sent for allergy investigation to role out allergy. Patients go through penicillin test and if negative are challenged by oral administration under medical observation. The investigators would like to check the incidence among our pediatric pediatric patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penicillin Allergy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
penicillin test and challenge
Intervention Type
Other
Intervention Name(s)
penicillin test
Intervention Description
children are tested for penicillin allergy and then challenged with penicillin P.O.
Primary Outcome Measure Information:
Title
The incidence of reactions during penicillin challenge tests among children with suspected penicillin allergy
Description
To find out how many children are actually true allergic to penicillin
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children older then 6 month with suspected penicillin allergy
Exclusion Criteria:
Children under 6 month old
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
IRIS DAHAN, MSc
Phone
00972546620184
Email
IRIS2204@GMAIL.COM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
vered schichter- konfino, MD
Organizational Affiliation
Hillelyaffe medical center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Frequency of Positive Challenge Test to Penicillin in Children Suspected to Have Allergy to Penicillin
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