Clinical Research Directory

A Digital Stewardship Strategy for Patients With Reported Penicillin Allergy

The goal of this clinical study is to evaluate whether a digital decision support tool integrated into the electronic medical record improves antibiotic prescribing in hospitalized patients with a reported allergy to penicillin. Around 5 out of 100 hospitalized patients at our center have a penicillin allergy label in their medical record. However, this allergy is confirmed in less than 10 out of 100 cases. Despite this, more than 90 out of 100 of these patients receive alternative antibiotics that may be less effective or less aligned with clinical guidelines. This study includes adults older than 16 years treated at Hospital Sant Joan de Déu de Manresa (Althaia) for infections that require systemic antibiotic treatment. Participants are those with a recorded penicillin allergy in their medical record or who report an allergy during their current hospital admission. The main questions this study aims to answer are: Does the use of a digital decision support tool increase the use of beta-lactam antibiotics (such as penicillins and cephalosporins) in patients with a reported penicillin allergy? Does the tool reduce the use of alternative antibiotic treatments that are less aligned with hospital guidelines? Participants will receive standard clinical care. In addition, healthcare professionals will use a digital tool integrated into the electronic medical record. This tool supports clinical decision-making by assessing individual allergy risk and aligning antibiotic selection with hospital treatment guidelines. The study will last approximately 15 months and will be conducted at a single hospital center.

Provocation After Nurse-Directed Assessment (PANDA) Study

The study aims to evaluate the effectiveness and safety of a collaborative nurse-allergist approach in penicillin allergy delabeling services. It also seeks to assess the impact on patients' quality of life and compare resource utilization and cost-effectiveness between the nurse-allergist collaborative approach and the traditional allergist-led approach.

A Study of the Impact of Penicillin Allergy on Antimicrobial Resistance and ouTcomes

Penicillin allergy is one of the commonest reported allergies. The presence of a penicillin allergy record in a patients notes leads to the avoidance of recommended first-line penicillin antibiotics and the use of alternative non-penicillin antibiotics which can be less effective, have more side effects and have a greater propensity to drive antimicrobial resistance (AMR). Most patients with penicillin allergy records do not have a true allergy when they are tested by a specialist, so many patients are denied the best antibiotics because of an incorrect penicillin allergy record. The study will investigate how having a penicillin allergy impacts on treatment for patients who need antibiotics when they are hospitalised with COVID-19 and how penicillin allergy affects AMR. Antibiotic use is the main driver of AMR, antibiotic use can also disrupt the bacteria that normally live in our guts and mouths. These bacterial communities also known as the gastrointestinal (GI) and oral microbiome respectively, help us digest food and prevent infections. Antibiotic use can 'kill off' these harmless bacteria and lead to an increase in bacteria which have genes that make them resistant to antibiotics (antibiotic resistance genes). The study investigators believe that patients with penicillin allergy are likely to have a greater number of antibiotic resistance genes in their oral and GI microbiomes, ans that this will make it more likely that they will fail antibiotic treatment and will increase their risk of transmitting resistance to others. The study objectives are: 1. To determine how penicillin allergy impacts on clinical outcomes in patients admitted with COVID-19 2. To find out if AMR genes in the oral microbiome of people with a penicillin allergy record are different to those without a penicillin allergy record 3. To investigate whether AMR genes are lost in patients who have an incorrect penicillin allergy label removed

Geisinger Antibiotic Allergy Pilot Program: Assess and Address

This is a prospective non-inferiority study to evaluate penicillin allergy history in patients with reported penicillin allergy, who require penicillin or penicillin-derivative antibiotic during inpatient admission using a focused questionnaire. A simplified scoring system will be assigned to patient responses, and the total score will be utilized to identify low-risk patients that have a minimal risk of allergic reactions on exposure to penicillin or its derivative. Patients determined to have low risk based on this questionnaire will be offered a test dose (graded challenge) of amoxicillin in a supervised setting, and if they tolerate it, penicillin allergy label will be removed from patient's chart. We hypothesize that at least 95% of low-risk patients will successfully pass the graded amoxicillin challenge so the penicillin allergy label can be removed from their charts. A proportion as low as 0.85 would be a good clinical outcome and considered non-inferior to the expected proportion of 0.95.

Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge

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.

Risk-stratified Testing for Safe Removal of Penicillin Allergy Labels

The aim of this clinical trial is to analyze the negative predictive capacity and safety of risk-stratified direct drug provocation tests for patients with self-reported penicillin allergies. Patients reporting immediate or delayed penicillin allergies and defined as low-risk by the PEN-FAST score will receive drug provocation tests without prior skin testing.

Evaluating the Feasibility of High-volume, Low-risk Penicillin Allergy De-labelling to Maximise Efficiency in a Resource-limited Setting

Plenty of studies have now established the safety of low-risk penicillin allergy de-labelling, but few have addressed how to organise de-labelling at the clinic level. This study will test the real world practicalities of running a de-labelling clinic optimised for maximum patient volume. The sheer number of patients with a penicillin allergy label, in contrast to relatively few allergy centres, makes demonstrating that such an approach can work extremely important for future antimicrobial stewardship.

Removal of Erroneous Penicillin Allergy Labels: Implementation Study (REPeAL)

To test the implementation of penicillin allergy de-labelling delivered by the responsible clinical teams and the antimicrobial stewardship teams across all medical, surgical and critical care specialities in a UK hospital using the developed toolkit and a validated penicillin allergy decision support tool.