The Frequency of Positive Challenge Test to Penicillin in Children Suspected to Have Allergy to Penicillin

March 7, 2016 updated by: Hillel Yaffe Medical Center
The incidence of reactions during penicillin challenge tests among children with suspected penicillin allergy

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children older then 6 month with suspected penicillin allergy

Exclusion Criteria:

  • Children under 6 month old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
penicillin test and challenge
Other: penicillin test
children are tested for penicillin allergy and then challenged with penicillin P.O.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of reactions during penicillin challenge tests among children with suspected penicillin allergy
Time Frame: one year
To find out how many children are actually true allergic to penicillin
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: vered schichter- konfino, MD, Hillelyaffe medical center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

March 7, 2016

First Posted (Estimate)

March 8, 2016

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 52-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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