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

• Sponsor: Joseph D. Tobias (Other)
• Overall Status: Completed
• CT.gov ID: NCT02036840
• Collaborator: (none)
• Enrollment: 513
• Location: 1
• Duration (Months): 22
• Patients Per Site Per Month: 23.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Penicillin Allergy	Drug: Antibiotic

Study Design

• Study Type: Observational
• Actual Enrollment: 513 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Penicillin allergy	Drug: Antibiotic

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Antibiotic Related Adverse Event [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205

Sponsors and Collaborators

• Joseph D. Tobias

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joseph D. Tobias, Chairman - Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital
• ClinicalTrials.gov Identifier: NCT02036840
• Other Study ID Numbers: IRB11-00822
• First Posted: Jan 15, 2014
• Last Update Posted: Apr 22, 2015
• Last Verified: Apr 1, 2015

• Additional relevant MeSH terms: Anti-Bacterial Agents

Study Results

Participant Flow

Arm/Group Title	Penicillin Allergy
Arm/Group Description	Antibiotic
Period Title: Overall Study
STARTED	513
COMPLETED	513
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Penicillin Allergy
Arm/Group Description	Antibiotic
Overall Participants	513
Age (Count of Participants)
<=18 years	513 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	250 48.7%
Male	263 51.3%
Region of Enrollment (participants) [Number]
United States	513 100%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Antibiotic Related Adverse Event
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Penicillin Allergy
Arm/Group Description	Antibiotic
Measure Participants	513
Number [participants]	12 2.3%

Adverse Events

Adverse Event Reporting Description	Please note: This is a retrospective chart review so the antibiotic related adverse events listed below occurred before the study even started.
Arm/Group Title	Penicillin Allergy
Arm/Group Description	Antibiotic
All Cause Mortality
	Penicillin Allergy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Penicillin Allergy
	Affected / at Risk (%)	# Events
Total	0/513 (0%)
Other (Not Including Serious) Adverse Events
	Penicillin Allergy
	Affected / at Risk (%)	# Events
Total	12/513 (2.3%)
General disorders
Hypotension	1/513 (0.2%)
Immune system disorders
Hives	4/513 (0.8%)
Erythema	1/513 (0.2%)
Rash	6/513 (1.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.