NCT02702349

Brief Summary

The incidence of reactions during penicillin challenge tests among children with suspected penicillin allergy

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 8, 2016

Status Verified

February 1, 2016

Enrollment Period

10 months

First QC Date

March 3, 2016

Last Update Submit

March 7, 2016

Conditions

Penicillin Allergy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

1

OTHER

penicillin test and challenge

Other: penicillin test

Interventions

penicillin testOTHER

children are tested for penicillin allergy and then challenged with penicillin P.O.

1

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children older then 6 month with suspected penicillin allergy

You may not qualify if:

  • Children under 6 month old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • vered schichter- konfino, MD

    Hillelyaffe medical center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

IRIS DAHAN, MSc

CONTACT

00972546620184IRIS2204@GMAIL.COM

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2016

First Posted

March 8, 2016

Study Start

April 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 8, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share