Penicillin AllergyPenDelNCT05956080
Penicillin Allergy Delabeling Among Surgical Patients
A study testing Allergy testing in people with Penicillin Allergy, run by University Medicine Greifswald.
Trial summary
Penicillin allergy testing among surgical patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Penicillin Allergy
- What is being tested?
- Allergy testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Sep 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- surgical patients with reported penicillin allergy
Who cannot join
- missing consent
Trial locations and contacts
No sites are listed yet.
About this study
Penicillin allergy testing among surgical patients
- Conditions
- Penicillin Allergy
- Being tested
- Allergy testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergy testingDiagnostic test
University Medicine Greifswald
| Study group | Role | What they receive |
|---|---|---|
| Allergy testing | Other | Not described Receives: Diagnostic Test: Allergy testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed penicillin allergy
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penicillin AllergyStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian Gibb, MD, Principal investigator, University Medicine GreifswaldChristian S. Scheer, MD, Principal investigator, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956080
- Sponsor's protocol ID
- 003
- Acronym
- PenDel
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penicillin Allergy Delabeling Among Surgical Patients
- ClinicalTrials.gov ID
- NCT05956080
- Acronym / sponsor ID
- PenDel / 003
- Conditions
- Penicillin Allergy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 21 Jul 2023 (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.
Penicillin allergy testing among surgical patients
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allergy testing | Other | Diagnostic Test: Allergy testing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- surgical patients with reported penicillin allergy
Key exclusion criteria (1 listed)
- missing consent
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 |
|---|---|---|
| Allergy testingUniversity Medicine Greifswald | Diagnostic test | Allergy testing |
Primary outcome
Confirmed penicillin allergy
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
Sebastian Gibb, MD principal investigator
University Medicine Greifswald
Christian S. Scheer, MD principal investigator
University Medicine Greifswald
Questions about this trial
What is this clinical trial studying?
A study testing Allergy testing in people with Penicillin Allergy, run by University Medicine Greifswald.
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: status not confirmed, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Gibb, MD (00493834 86 5801, sebastian.gibb@med.uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed penicillin allergy (time frame: 1 week). 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 21 Jul 2023.