Negative Predictive Value and NIC of Beta-Lactam Antibiotics.

Mayo Clinic

Status: Completed

Conditions: Allergy

Treatments: Diagnostic Test: Skin Testing beta-lactams

Study type: Interventional

Funder types: Other

Identifiers

NCT04126096

19-002587

Details and patient eligibility

About

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.

Full 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).

Enrollment: 747 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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747 participants in 1 patient group

Study Group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Skin Testing beta-lactams