Using genetic testing to improve medication safety in hospitals
PHOENIX TRIAL - A PILOT RANDOMISED CONTROLLED TRIAL OF PRE-EMPTIVE PHARMACOGENOMICS IN ACUTE CARE SETTINGS WITH HEALTH ECONOMIC EVALUATIONS
This study is testing whether genetic testing can help doctors choose safer medications for hospitalized patients to reduce side effects and treatment failures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NHS Greater Glasgow and Clyde Academic / other |
| Locations | 5 sites (Clydebank and 4 other locations) |
| Trial ID | NCT06907784 on ClinicalTrials.gov |
What this trial studies
The PHOENIX trial is a pilot randomized trial that aims to evaluate the effectiveness of pharmacogenomic testing in reducing adverse drug reactions and treatment failures among hospitalized patients or those attending specialist clinics. Participants will undergo genetic testing through buccal swab samples to identify gene variations that may affect their response to certain medications. The trial will also assess the health-economic impact of implementing pharmacogenomic-guided care in clinical settings. Conducted at Queen Elizabeth University Hospital in Glasgow, the study will focus on patients prescribed specific medications with known pharmacogenomic implications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are newly prescribed specific medications with pharmacogenomic implications and can provide informed consent.
Not a fit: Patients who have been prescribed the same medication in the past three months or those with a life expectancy of less than six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of adverse drug reactions and improve treatment outcomes for patients.
How similar studies have performed: Other studies have shown promise in using pharmacogenomic approaches to improve medication safety, indicating that this method is gaining traction in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria INPATIENTS Age ≥18 years * Capable of giving informed consent directly or via a legal representative (e.g., next of kin, welfare guardian, health care power of attorney). * Participants who are newly prescribed one of the trial-eligible index drugs during their hospital stay may be approached for consent. Consent should be obtained within 3 days of the first dose of the index drug being administered. If there is a clear clinical plan documented on HEPMA indicating that the patient will be started on an eligible drug (but has not yet received the first dose), consent may be obtained in anticipation. However, formal trial enrolment will only occur once the first dose of the index drug has been administered. * Participant is able to provide a cheek swab * Participant is able to take part and be followed-up for at least 12 weeks. * Participant is resident in NHSGGC health board area OUTPATIENTS * Age ≥18 years * Capable of giving informed consent directly or via a legal representative (e.g., next of kin, welfare guardian, health care power of attorney). * Participants who are expected to be prescribed a trial-eligible drug during their outpatient clinic visit may be approached for consent prior to starting the medication. In these cases, formal trial enrolment will only occur once the patient has confirmed that they have received and started the prescribed medication * Participant must not have a prescription for this drug in the previous 3 months. * Participant is able to provide a cheek swab * Participant is able to take part and be followed-up for at least 12 weeks. * Participant is resident in NHSGGC health board area. Exclusion Criteria INPATIENTS * Inability to give informed consent directly or via a legal representative. * Non-English speakers without translation support. * Participants co-enrolled in other trials where a medication is one of the index drug is part of the trial protocol. * Inability to give informed consent directly or via a legal representative. * Non-English speakers without translation support. * Participants co-enrolled in other trials where a medication is one of the index drug is part of the trial protocol. * Life expectancy estimated to be less than 6 months by treating clinical team. * Severe illness limiting participation (investigator discretion). * Duration of index drug total treatment length is planned to be less than five consecutive days. * Not registered with a General Practitioner. * No fixed address. * Participant is, in the opinion of the Investigator, not suitable to participate in the trial. * Participant has existing impaired hepatic or renal function for which a lower dose of the index drug or alternate selection of the index drug is already part of current routine care. * Estimated glomerular filtration rate greater than 15 ml/min/1.73m2 (except for participants with a renal transplant commenced on tacrolimus, who may be included regardless of eGFR, provided they are not on dialysis).eGFR result obtained at screening or within the last 6 months or patients record confirming history of CKD 5 * Participants on any form of dialysis. * Participant with advanced liver failure (stage Child-Pugh C). * Participants with liver transplant. * Participants with allogeneic haematopoietic stem cell transplant. * Participants previously enrolled in the PHOENIX trial. * Participant who has declined participation and has declined reapproach for subsequent drugs. * Index drug exceeding trial drug cap. OUTPATIENTS * Inability to give informed consent directly or via a legal representative. * Non-English speakers without translation support. * Participants co-enrolled in other trials where a medication is one of the index drug is part of the trial protocol. * Life expectancy estimated to be less than 6 months by treating clinical team. * Severe illness limiting participation (investigator discretion). * Duration of index drug total treatment length is planned to be less than seven consecutive days. * Not registered with a General Practitioner. * No fixed address. * Participant is, in the opinion of the Investigator, not suitable to participate in the trial. * Participant has existing impaired hepatic or renal function for which a lower dose or alternate drug selection is already part of current routine care. * Estimated glomerular filtration rate greater than 15 ml/min/1.73m2 (except for participants with a renal transplant commenced on tacrolimus, who may be included regardless of eGFR, provided they are not on dialysis)..eGFR result obtained at screening or within the last 6 months or patients record confirming history of CKD 5. * Participants on any form of dialysis. * Participant with advanced liver failure (stage Child-Pugh C). * Participants with liver transplant. * Participants with allogeneic haematopoietic stem cell transplant. * Participants previously enrolled in the PHOENIX trial. * Participant who has declined participation and has declined reapproach for subsequent drugs. * Index drug exceeding trial drug cap. Re-approach Criteria: Previously declined patients will only be re-approached in subsequent admissions six-months after the first approach. \* We wish to ensure that no more than 20% of participants are included on the basis of any single index drug. The numbers recruited on each index drug will be monitored and recruitment on specific drugs may be limited, or paused, at times throughout the study. This process will be administered by the Trial Management group, and monitored by the Trial Steering Committee.
Where this trial is running
Clydebank and 4 other locations
- Golden Jubilee National Hospital — Clydebank, United Kingdom (Recruiting)
- Queen Elizabeth University Hospital — Glasgow, United Kingdom (Recruiting)
- Glasgow Royal Infirmary — Glasgow, United Kingdom (Recruiting)
- Leverndale Hospital — Glasgow, United Kingdom (Recruiting)
- Royal Alexandra Hospital — Glasgow, United Kingdom (Active_not_recruiting)
Study contacts
- Principal investigator: Sandosh Padmanabhan, MD PhD — University of Glasgow
- Study coordinator: Elaine O'Neill
- Email: elaine.oneill3@nhs.scot
- Phone: 0141 451 6869
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.