NCT02036840

Brief Summary

The proposed research project will retrospectively review the anesthetic records over the past 5 years and identify patients who present with a history of penicillin allergy or allergy to an antibiotic in the penicillin family. The reason for that history and the facts on which that allergy are noted will be determined. Additionally, the choice of antibiotic prophylaxis will be recorded and any adverse effect to that antibiotic noted. We will also note whether appropriate timing of the antibiotic is achieved.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
513

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
6 months until next milestone

Results Posted

Study results publicly available

April 22, 2015

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

1.8 years

First QC Date

January 13, 2014

Results QC Date

February 12, 2015

Last Update Submit

April 20, 2015

Conditions

Penicillin Allergy

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Antibiotic Related Adverse Event

    24 hours

Study Arms (1)

Penicillin allergy

Drug: Antibiotic

Interventions

AntibioticDRUG
Penicillin allergy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a history of allergy to penicillin who required antibiotic prophylaxis prior to/during surgery.

You may qualify if:

  • Patients that are labeled as penicillin or penicillin family allergic.

You may not qualify if:

  • As neurosurgical patients routinely receive vancomycin at NCH for surgical prophylaxis, they will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Results Point of Contact

Title
Ralph Beltran, MD
Organization
Nationwide Children's Hospital
Ralph.Beltran@nationwidechildrens.org
614-722-4200

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chairman - Dept. of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 15, 2014

Study Start

January 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 22, 2015

Results First Posted

April 22, 2015

Record last verified: 2015-04

Locations

US(1)