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NCT Number: NCT04126096

Negative Predictive Value and NIC of Beta-Lactam Antibiotics.

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.

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Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Jacksonville, Florida, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Skin Testing beta-lactams

Diagnostic Test

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 15, 2019
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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