NCT03499457

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.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

7 months

First QC Date

April 8, 2018

Last Update Submit

April 8, 2018

Conditions

Penicillin Allergy

Keywords

Penicillin Allergychalenge testprimary clinic

Outcome Measures

Primary Outcomes (1)

  • immidiate urticarial reaction

    shortness of breath, angioedema

    with 2 hours of test

Secondary Outcomes (1)

  • rash

    with 2 hours of test

Study Arms (1)

treatment

EXPERIMENTAL

penicillin chalange test, as descibed.

Drug: Amoxicillin

Interventions

AmoxicillinDRUG

chalange test of 50 mg, and after an hour 500 mg

treatment

Eligibility Criteria

Age5 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • penicillin allergy in the medical record

You may not qualify if:

  • pregnancy lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Amoxicillin

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • lital f goldberg, MD. MPH

    Clalit Health Services

    PRINCIPAL INVESTIGATOR

Central Study Contacts

lital f goldberg, MD. MPH.

CONTACT

972544248284litalmargalith@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr lital goldberg

Study Record Dates

First Submitted

April 8, 2018

First Posted

April 17, 2018

Study Start

June 1, 2018

Primary Completion

January 1, 2019

Study Completion

June 1, 2019

Last Updated

April 17, 2018

Record last verified: 2018-04