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
-
-
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.
|
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
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.