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NCT04126096 Clinical Trial

Negative Predictive Value and NIC of Beta-Lactam Antibiotics.

Allergy Clinical Trial

Official title:
The Negative Predictive Value and Non-irritant Skin Testing Concentrations of Beta-Lactam Containing Antibiotics Other Than Penicillin.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04126096
Other study ID # 19-002587
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2019
Est. completion date January 6, 2023

Study information
Verified date June 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 747
Est. completion date January 6, 2023
Est. primary completion date January 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Skin Testing beta-lactams
Percutaneous skin prick followed by Intradermal Injections of NMBAs at increasing concentrations compared with an established positive and negative control.

Locations
Country Name City State
United States Mayo Clinic Jacksonville Florida
United States Mayo Clinic in Florida Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Max Concentration used when skin testing to beta lactam containing antibiotics other than penicillin Close gap on the variability of the maximal concentration used when skin testing beta lactam containing antibiotics. 1 Year
Primary Non-Irritant Concentrations to common beta lactam containing antibiotics other than penicillin Determine the NIC to common beta lactam containing antibiotics 1 Year
Secondary Negative Predictive Value of Intradermal Skin Testing to commonly used beta lactam containing antibiotics other than penicillin Determine Negative Predictive Value of Intradermal Skin Testing to commonly used beta lactam containing antibiotics 1 Year
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