AllergyNCT04126096
Negative Predictive Value and NIC of Beta-Lactam Antibiotics.
A study testing Skin Testing beta-lactams in people with Allergy, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergy
- What is being tested?
- Skin Testing beta-lactams
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 747 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Sep 2019to 6 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults > or = to 18 y/o undergoing surgery
Who cannot join
- Minors under the age of 18 y/o, Adults unable to consent, or those Adults with previous allergic reaction history during previous surgeries.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic
Jacksonville, Florida, 32224
About this study
Official title: 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.
Read the 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).
- Conditions
- Allergy
- Being tested
- Skin Testing beta-lactams
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Skin Testing beta-lactams |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Irritant Concentrations to common beta lactam containing antibiotics other than penicillin
Determine the NIC to common beta lactam containing antibiotics
Measured: 1 Year
Secondary outcomes (1)
Negative Predictive Value of Intradermal Skin Testing to commonly used beta lactam containing antibiotics other than penicillin
Determine Negative Predictive Value of Intradermal Skin Testing to commonly used beta lactam containing antibiotics
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start20 Sep 2019
- Primary completion6 Jan 2023
- Study completion6 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Skin testing
- Masking
- None (open label)
- Enrolment
- 747 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexei Gonzalez-Estrada, MD, Mayo Clinic
- Investigators
- Alexei Gonzalez Estrada, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126096
- Sponsor's protocol ID
- 19-002587
- Status last verified
- Jun 2023
- First submitted
- 11 Oct 2019
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Negative Predictive Value and Non-irritant Skin Testing Concentrations of Beta-Lactam Containing Antibiotics Other Than Penicillin.
- ClinicalTrials.gov ID
- NCT04126096
- Acronym / sponsor ID
- 19-002587
- Conditions
- Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 747 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Skin testing
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Diagnostic Test: Skin Testing beta-lactamsStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults > or = to 18 y/o undergoing surgery
Key exclusion criteria (1 listed)
- Minors under the age of 18 y/o, Adults unable to consent, or those Adults with previous allergic reaction history during previous surgeries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin Testing beta-lactamsPercutaneous skin prick followed by Intradermal Injections of NMBAs at increasing concentrations compared with an established positive and negative control. | Diagnostic test | Study Group |
Primary outcome
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 secondary outcome
Negative Predictive Value of Intradermal Skin Testing to commonly used beta lactam containing antibiotics other than penicillin
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexei Gonzalez Estrada, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin Testing beta-lactams in people with Allergy, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-Irritant Concentrations to common beta lactam containing antibiotics other than penicillin (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.