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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02036840
First Posted: January 15, 2014
Last Update Posted: April 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital
  Purpose
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.

Condition Intervention
Penicillin Allergy Drug: Antibiotic

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Joseph D. Tobias, Nationwide Children's Hospital:

Primary Outcome Measures:
  • Number of Subjects With Antibiotic Related Adverse Event [ Time Frame: 24 hours ]

Enrollment: 513
Study Start Date: January 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Penicillin allergy Drug: Antibiotic

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a history of allergy to penicillin who required antibiotic prophylaxis prior to/during surgery.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036840


Locations
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Joseph D. Tobias
  More Information

Responsible Party: Joseph D. Tobias, Chairman - Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02036840     History of Changes
Other Study ID Numbers: IRB11-00822
First Submitted: January 13, 2014
First Posted: January 15, 2014
Results First Submitted: February 12, 2015
Results First Posted: April 22, 2015
Last Update Posted: April 22, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Anti-Bacterial Agents
Penicillins
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents