Negative Predictive Value and NIC of Beta-Lactam Antibiotics.

Not Applicable

Completed

• Conditions: Allergy
• Interventions: Diagnostic Test: Skin Testing beta-lactams

• Registration Number: NCT04126096
• Lead Sponsor: Mayo Clinic

Brief Summary

The researchers are trying to evaluate how much medication is required for allergy skin testing and to determine the likelihood that patients with a negative test truly don't have an allergy to the tested drug of skin testing to commonly used antibiotics.

Detailed Description

This study will be a prospective study to accurately determine the negative predictive value of skin testing with beta lactam containing antibiotics other than penicillin .

It is hypothesized that the concentrations that should be used for beta lactams are actually much lower than previously recommended and that the higher incidence of identifiable beta lactam induced allergic reactions during anesthesia in the past may be due to irritation of the skin rather than a true allergic reaction (false positives).

Study Timeline

• Study Start: 2019-09-20
• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-15
• Primary Completion: 2023-01-06
• Study Completion: 2023-01-06
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-19
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 747

Inclusion Criteria

• All adults > or = to 18 y/o undergoing surgery

Exclusion Criteria

• Minors under the age of 18 y/o, Adults unable to consent, or those Adults with previous allergic reaction history during previous surgeries.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	Skin Testing beta-lactams	Study team is developing a new diagnostic skin testing procedure for patients who receive beta lactam containing antibiotics during surgery (other than penicillin) in order to determine Negative Predictive Values and Non-Irritant Concentrations.

Primary Outcome Measures

Name	Time	Method
Non-Irritant Concentrations to common beta lactam containing antibiotics other than penicillin	1 Year	Determine the NIC to common beta lactam containing antibiotics

Secondary Outcome Measures

Name	Time	Method
Negative Predictive Value of Intradermal Skin Testing to commonly used beta lactam containing antibiotics other than penicillin	1 Year	Determine Negative Predictive Value of Intradermal Skin Testing to commonly used beta lactam containing antibiotics

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States