Actively Recruiting
PHOENIX Trial - A Pilot Randomised Controlled Trial of Pre-Emptive Pharmacogenomics in Acute Care Settings with Health Economic Evaluations
Led by NHS Greater Glasgow and Clyde · Updated on 2026-04-21
2000
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
N
NHS Greater Glasgow and Clyde
Lead Sponsor
U
University of Glasgow
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how genetic differences affect peoples responses to medicines, which can cause benefits, no effects, or side-effects. This study, called PHOENIX, aims to see if genetic testing before prescribing new medicines can reduce harmful reactions and treatment failures in adult patients admitted to hospital or attending outpatient clinics. It also assesses the cost impact of this genetic-guided care. Participants include adults from various medical specialties who receive medicines with known genetic implications. Participants will be randomly assigned to one of two groups. One group will have their genetic test results analyzed immediately to guide medication decisions, while the other group will have testing done after three months as standard care. All participants provide a cheek swab for DNA testing. The results help doctors decide if any medication changes are needed. Both groups will be monitored for medication side-effects, changes, and quality of life over three months. During the study, participants will complete questionnaires monthly on quality of life, medication adherence, and side-effects. Blood tests may be done around four weeks based on the medication used. Researchers will also collect data on hospital admissions, new prescriptions, and deaths from health records. The main outcome measured is the combination of adverse drug reactions and treatment failures within three months. The study involves follow-up for at least 12 weeks, with safety and health economic evaluations included.
CONDITIONS
Brief Title
PRE-EMPTIVE PHARMACOGENOMICS IN ACUTE CARE SETTINGS WITH HEALTH ECONOMIC EVALUATIONS (PHOENIX TRIAL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older
- Able to give informed consent directly or via a legal representative
- Newly prescribed one of the trial's eligible drugs during hospital stay or outpatient clinic
- Consent obtained within 3 days of first dose (inpatients) or before starting medication (outpatients)
- Able to provide a cheek swab
- Able to participate and be followed up for at least 12 weeks
- Resident in NHSGGC health board area
You will not qualify if you...
- Unable to give informed consent directly or via a legal representative
- Non-English speakers without translation support
- Co-enrolled in other trials involving an index drug
- Life expectancy less than 6 months
- Severe illness limiting participation
- Planned treatment with index drug less than 5 days (inpatients) or 7 days (outpatients)
- Not registered with a General Practitioner
- No fixed address
- Deemed unsuitable by Investigator
- Existing impaired liver or kidney function needing dose adjustment already in routine care
- Estimated glomerular filtration rate less than or equal to 15 ml/min/1.73m2 (except renal transplant patients on tacrolimus not on dialysis)
- On any form of dialysis
- Advanced liver failure (Child-Pugh C)
- Liver transplant recipient
- Allogeneic haematopoietic stem cell transplant recipient
- Previously enrolled in PHOENIX trial
- Declined participation and re-approach
- Index drug exceeding trial drug cap
Research Team
E
Elaine O'Neill
S
Stefanie Lip, PhD MBChB BSc
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