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New treatment option for Pharmacogenomic Drug Interaction
Official title PRE-EMPTIVE PHARMACOGENOMICS IN ACUTE CARE SETTINGS WITH HEALTH ECONOMIC EVALUATIONS (PHOENIX TRIAL)
ClinicalTrials.gov ID: NCT06907784
What this study is testing
- What it's testing
- It is known that individuals respond differently to the same medicine with some people benefitting, some experiencing no effect and others suffering side-effects or even coming to harm. Some of the differences in response to medications can be explained by our genes.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Participant is able to provide a cheek swab
- Participant is able to take part and be followed-up for at least 12 weeks.
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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.
What rules you out
- 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...
- 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...
- 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%...
The study team makes the final eligibility decision.
Where it's taking place
- Clydebank, United Kingdom
- Glasgow, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clydebank, United Kingdom; Glasgow, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.