PRE-EMPTIVE PHARMACOGENOMICS IN ACUTE CARE SETTINGS WITH HEALTH ECONOMIC EVALUATIONS (PHOENIX TRIAL)

Exclusion Criteria

• •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 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. 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.