Penicillin Allergy Delabeling Project

Status Completed

Clinical Trial Summary

A investigational study to establish: 1. A validated cllinical pathway for delabeling declared Penicillin allergiy outside allergologic departments. 2. A survey to examine anesthesiologists attitudes and knowledge about penicillin delabeling. 3. A qualitative focus group study investigating barriers and facilitators in penicillin delabeling among hospital nurses and physichians. 2. Implement the pathway for delabeling declared penicillin allergy outside allergologic clinics across the Western Norway health region.

Clinical Trial Description

Patients labeled penicillin allergic is a significant and growing public health problem. 10% of all patients report penicillin allergy. 9 out of 10 however tolerate penicillin on provocation, To be labeled as penicillin allergic has several well documented negative health outcomes for the individual, and on a public health scale. One of the biggest obstacles in delabeling penicillin allergy is the lack of validated tools i Norwegian, the lack of in vitro tests for severe late /T cell mediated reactions and the accessibility of the gold standard procedure, drug provocation test. In this study patients having a penicillin allergy label will after giving their written concent be screened used a risk stratification tool. The low risk patient will then directly undergo a single full dose amoxicillin challenge. High risk patients are refered to a allergologic clinic and undergoes full allergologic examination. The investigators seek to document that in low risk patients is a single dose Amoxicillin challenge safe and beneficial outside an allergologic clinic, and to validate the risk stratification tool in Norwegian. To implement such pathways i qualitative data is needed to facilitate the right efforts and translate the method into every day clinical practice in a sustainable way. Here a anesthesiologist survey and focus group interviews with hospital nurses and physichians is planned. Finally we will implement the method in an implementation study across the Western Norway Health region ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05090527
Study type	Interventional
Source	Haukeland University Hospital
Contact
Status	Completed
Phase	N/A
Start date	July 28, 2021
Completion date	May 1, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05563610` - Oral Penicillin Challenge and Allergy De-labeling in Children	Phase 4
Completed	`NCT05020327` - Inpatient Penicillin Allergy Delabeling Study	Phase 4
Completed	`NCT04441021` - Feasibility Assessment of Risk Stratification and Oral Challenge in Hospitalized Children at Low Risk for Antibiotic Allergy
Not yet recruiting	`NCT05956080` - Penicillin Allergy Delabeling Among Surgical Patients	N/A
Recruiting	`NCT03757052` - Amoxicillin Challenge for Penicillin Allergy Diagnosis	N/A
Completed	`NCT03702270` - The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal	N/A
Recruiting	`NCT05464615` - Geisinger Antibiotic Allergy Pilot Program: Assess and Address	Early Phase 1
Completed	`NCT03702283` - Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting	N/A
Not yet recruiting	`NCT03499457` - Penicillin Allergy in Shfayim Clinic	N/A
Completed	`NCT01667055` - The Diagnosis of Beta-lactam Hypersensitivity in Thailand
Withdrawn	`NCT00589251` - Equivalency of Penicilloate Skin Test Reactivity Prepared by a Modified Alkaline Hydrolysis Technique	N/A
Completed	`NCT04620746` - Penicillin Allergy Testing in STD Clinics	Phase 4
Completed	`NCT03033394` - Beta-lactam Pharmacokinetics in Secondary Care
Completed	`NCT02036840` - Perioperative Antibiotic Choices for Surgical Prophylaxis in Penicillin-allergic Pediatric Patients	N/A
Terminated	`NCT00363688` - Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin	Phase 4
Completed	`NCT03158831` - Drug Challenges Without Prior Skin Testing	Phase 1
Recruiting	`NCT06303128` - Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge	Phase 3
Completed	`NCT03942731` - Penicillin Allergy Testing and Resensitization Rate
Completed	`NCT05010304` - Penicillin De-labeling in the Pediatric Primary Care Setting	Phase 4
Active, not recruiting	`NCT03404804` - Oral Challenge in the Pediatric ED	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Penicillin Allergy Delabeling Project — PenProv

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms