Negative Predictive Value and NIC of Beta-Lactam Antibiotics.

June 19, 2023 updated by: Alexei Gonzalez-Estrada, MD, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

747

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-Irritant Concentrations to common beta lactam containing antibiotics other than penicillin
Time Frame: 1 Year
Determine the NIC to common beta lactam containing antibiotics
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative Predictive Value of Intradermal Skin Testing to commonly used beta lactam containing antibiotics other than penicillin
Time Frame: 1 Year
Determine Negative Predictive Value of Intradermal Skin Testing to commonly used beta lactam containing antibiotics
1 Year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Max Concentration used when skin testing to beta lactam containing antibiotics other than penicillin
Time Frame: 1 Year
Close gap on the variability of the maximal concentration used when skin testing beta lactam containing antibiotics.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Alexei Gonzalez Estrada, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2019

Primary Completion (Actual)

January 6, 2023

Study Completion (Actual)

January 6, 2023

Study Registration Dates

First Submitted

October 11, 2019

First Submitted That Met QC Criteria

October 11, 2019

First Posted (Actual)

October 15, 2019

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-002587

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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