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NCT02036840 Clinical Trial

Perioperative Antibiotic Choices for Surgical Prophylaxis in Penicillin-allergic Pediatric Patients

Penicillin Allergy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02036840
Other study ID # IRB11-00822
Secondary ID
Status Completed
Phase N/A
First received January 13, 2014
Last updated April 20, 2015
Start date January 2013
Est. completion date November 2014

Study information
Verified date April 2015
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 513
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• Antibiotic

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Joseph D. Tobias

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Subjects With Antibiotic Related Adverse Event 24 hours No
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