Negative Predictive Value and NIC of Beta-Lactam Antibiotics.

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04126096

Enrollment

747

Registered

2019-10-15

Start date

2019-09-20

Completion date

2023-01-06

Last updated

2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

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.

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).

Interventions

DIAGNOSTIC_TESTSkin Testing beta-lactams

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Skin testing

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026