protocolSection identificationModule nctId: NCT06303128, orgStudyIdInfo id: IRB-FY2024-61, briefTitle: Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: James Tarbox, MD, class: OTHER, collaborators name: Texas Tech University Health Sciences Center, descriptionModule briefSummary: The goal of this clinical trial is to learn about dosing when testing to see if a penicillin allergy label can be removed from adults that had been labeled as "penicillin-allergic" previously. The main question it aims to answer is:- In penicillin-allergic patients that are at low risk of having an allergic reaction, is a one-dose oral challenge with amoxicillin (a penicillin-based antibiotic) as safe and effective as a two-dose oral challenge?Participants will, after being identified as having a low-risk penicillin allergy, be administered oral amoxicillin in a controlled setting and then monitored for an allergic reaction. Researchers will compare participants that took one dose of amoxicillin to participants that took two doses of amoxicillin (a small dose and then a larger dose) to see if either group was more likely to develop an allergic reaction., conditionsModule conditions: Penicillin Allergy, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: - Low-risk penicillin allergic patients ("low-risk" determined by a PEN-FAST score of 2 or less) will be recruited. Clinically stable patients will be randomly assigned in a double-blinded manner to receive either a one-dose or graded two-dose direct oral challenge with amoxicillin in an outpatient setting. Those assigned to receive one dose of amoxicillin will receive a placebo in place of a second dose of amoxicillin. Both groups will receive the same cumulative dose of amoxicillin (250mg) by the end of the trial. Baseline vital signs will be obtained and tracked throughout the trial. Patients will also be monitored for development of signs of allergic reactions during the trial, with administration of appropriate treatment should the need arise., primaryPurpose: DIAGNOSTIC, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 380, type: ESTIMATED, armsInterventionsModule interventions name: Amoxicillin 250 MG, interventions name: Placebo, interventions name: Amoxicillin 62.5mg, interventions name: Amoxicillin 187.5mg, outcomesModule primaryOutcomes measure: Proportion of successfully "delabeled" subjects in one-dose versus two-dose groups, secondaryOutcomes measure: Analysis of adverse reactions, secondaryOutcomes measure: Analysis of medical and allergic history, secondaryOutcomes measure: Validation of penicillin allergy delabeling, secondaryOutcomes measure: Analysis of demographic data, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Texas Tech University Health Sciences Center, status: RECRUITING, city: Lubbock, state: Texas, zip: 79430, country: United States, contacts name: Study Coordinator, role: CONTACT, phone: 806-543-8994, email: clinicalresearch@ttuhsc.edu, contacts name: Joshua A Peterson, MD, role: CONTACT, email: josh.peterson@ttuhsc.edu, contacts name: Joshua A Peterson, MD, role: SUB_INVESTIGATOR, contacts name: Nicole Welch, MD, role: SUB_INVESTIGATOR, contacts name: KaKa L Adams, MD, role: SUB_INVESTIGATOR, contacts name: Barbara Mora Gonzalez, MD, role: SUB_INVESTIGATOR, contacts name: Sebastian Sanchez Lopez, MD, role: SUB_INVESTIGATOR, contacts name: Sierra Sullivan, MD, role: SUB_INVESTIGATOR, contacts name: Jacob Nichols, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: James A Tarbox, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.57786, lon: -101.85517, hasResults: False