Penicillin Allergy in Shfayim Clinic

April 8, 2018 updated by: Dr. Lital Goldberg, Clalit Health Services
revising penicillin allergy in the medical records, by taking full medical history and giving a challange test, in order to imrove the medical records and treatment possibilities.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

issuing a list of patients with a title of penicillin allergy in their medical record. inviting these patients to an appointmnet with their family physician, in which a specific history will be take to evaluate the quality of the allergy.

patients with suscpition of a life threatening allergic reaction will be reffered to an allergy clinic for the challange test. the rest of the pateints will be given the test in the primary clinic: 1ml (50 grams) of amoxicillin, and an hour later a full dose of 500 mg amoxicillin.

after determining no allergic reaction develops the title will be erased from the medical record.

Study Type

Interventional

Enrollment (Anticipated)

100

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

5 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

penicillin allergy in the medical record

Exclusion Criteria:

pregnancy lack of informed consent

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment
penicillin chalange test, as descibed.
Drug: Amoxicillin
chalange test of 50 mg, and after an hour 500 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
immidiate urticarial reaction
Time Frame: with 2 hours of test
shortness of breath, angioedema
with 2 hours of test

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rash
Time Frame: with 2 hours of test
body rash or itch seen by patient or physician
with 2 hours of test

Collaborators and Investigators

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

Sponsor

Clalit Health Services

Investigators

  • Principal Investigator: lital f goldberg, MD. MPH, Clalit health services

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 (Anticipated)

June 1, 2018

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

April 8, 2018

First Submitted That Met QC Criteria

April 8, 2018

First Posted (Actual)

April 17, 2018

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 8, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0185-17-COM2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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