The ALABAMA Trial

Allergy Antibiotics and Microbial Resistance

Objectives

The University of Leeds and University of Oxford are carrying out a research study aimed at finding out:

If people with a penicillin-allergy label in their GP health records really do have an allergy by specialist PAAP (Penicillin-Allergy Assessment Pathway) testing.
If we can reduce the number of patients wrongly labelled as penicillin allergic.
We will find out if this results in better use of antibiotics and fewer days of symptoms, when patients are prescribed antibiotics for infection.

We are asking GPs in West Yorkshire to help us with this research, and we hope to include 96 participants in the initial feasibility study and 1,994 participants in the main study.

Trial Design

Patients with medical records that state that they are allergic to penicillin antibiotics, are over 18 years old, and have taken an antibiotic in the previous 12 months will be invited to take part in the ALABAMA trial. Eligible patients who would like to proceed will be asked to sign a consent form before participating in the study. Patients will be randomly allocated to either the Penicillin Allergy Assessment Pathway (PAAP) study group or usual care.

Patients assigned to the usual care group, will not be required to attend any further visits for the purpose of the trial. Patients assigned to the PAAP study group will be asked to attend one clinic appointment at the immunology clinic at St James’s University Hospital. This appointment will involve a patient questionnaire to assess risk of anaphylaxis, either a skin test or straight to the ‘oral challenge’ test. The oral challenge test involves three doses of penicillin in an hour. Patients will be monitored closely throughout this time and also one hour after the last dose. If there is no reaction to the oral test, patients will be asked to take penicillin at home for 3 days. Patients will receive the results of the PAAP test via letter within 3 days. GPs will be informed of the test results and will update their health records as needed. Patients will be followed up by phone call twice within 30 days post-PAAP.

Both usual care and PAAP groups if prescribed an antibiotic by their GP within 12 months after being entered into the study, will be asked to complete a daily symptom diary. Monthly follow up phone calls will take place in the first four months as part of the feasibility study. After 12 months a member of the study team will call patients to complete a final quality of life questionnaire. A few selected participants and practice staff will be invited to take part in a telephone interview as well.

For more information please see the further information section below. Alternatively, please contact the study team on the details below:

Contact details:
Chief Investigator: Dr Jonathan Sandoe
Local Contact: Mina Davoudianfar (Trial Manager)
Email: mina.davoudianfar@phc.ox.ac.uk
Tel: 01865 289336