The Frequency of Positive Challenge Test to Penicillin in... | NCT02702349

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

NCT02702349

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Mar 8, 2016Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Penicillin Allergy

Interventions

penicillin test

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

Feb 2016

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

Apr 2016

Primary Completion Date

Feb 2017Estimated

Completion Date

Feb 2017Estimated

First Submitted Date

Mar 3, 2016

First Submission Date that Met QC Criteria

Mar 7, 2016

First Posted Date

Mar 8, 2016Estimated

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

Mar 7, 2016

Last Update Posted Date

Mar 8, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

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.

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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	penicillin test and challenge	Other: penicillin test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
penicillin test	Other	children are tested for penicillin allergy and then challenged with penicillin P.O.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children older then 6 month with suspected penicillin allergy

Exclusion Criteria:

Children under 6 month old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
IRIS DAHAN, MSc	Contact	00972546620184		IRIS2204@GMAIL.COM

Overall Officials

Name	Affiliation	Role
vered schichter- konfino, MD	Hillelyaffe medical center	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided