Penicillin Allergy in Shfayim Clinic | NCT03499457

Studies
Penicillin Allergy in Shfayim Clinic

NCT03499457

Sponsor

Clalit Health Services

Status

Unknown status

Last Update Posted

Apr 17, 2018Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Penicillin Allergy

Interventions

Amoxicillin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2018Estimated

Primary Completion Date

Jan 2019Estimated

Completion Date

Jun 2019Estimated

First Submitted Date

Apr 8, 2018

First Submission Date that Met QC Criteria

Apr 8, 2018

First Posted Date

Apr 17, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2018

Last Update Posted Date

Apr 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment	Experimental	penicillin chalange test, as descibed.	Drug: Amoxicillin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amoxicillin	Drug	chalange test of 50 mg, and after an hour 500 mg	treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

penicillin allergy in the medical record

Exclusion Criteria:

pregnancy lack of informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
lital f goldberg, MD. MPH.	Contact	972544248284		litalmargalith@gmail.com

Overall Officials

Name	Affiliation	Role
lital f goldberg, MD. MPH	Clalit Health Services	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000658	Amoxicillin

Ancestor Terms

ID	Term
D000667	Ampicillin
D010400	Penicillin G
D010406	Penicillins
D047090	beta-Lactams
D007769

Browse Leaves

Not provided

Browse Branches

Not provided