NCT04126096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
747

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2019

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

3.3 years

First QC Date

October 11, 2019

Last Update Submit

June 19, 2023

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

  • Non-Irritant Concentrations to common beta lactam containing antibiotics other than penicillin

    Determine the NIC to common beta lactam containing antibiotics

    1 Year

Secondary Outcomes (1)

  • Negative Predictive Value of Intradermal Skin Testing to commonly used beta lactam containing antibiotics other than penicillin

    1 Year

Other Outcomes (1)

  • Max Concentration used when skin testing to beta lactam containing antibiotics other than penicillin

    1 Year

Study Arms (1)

Study Group

EXPERIMENTAL

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

Interventions

Skin Testing beta-lactamsDIAGNOSTIC_TEST

Percutaneous skin prick followed by Intradermal Injections of NMBAs at increasing concentrations compared with an established positive and negative control.

Study Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Related Links

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Alexei Gonzalez Estrada, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Skin testing
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 11, 2019

First Posted

October 15, 2019

Study Start

September 20, 2019

Primary Completion

January 6, 2023

Study Completion

January 6, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)