PREemptive pharmacogenomic testing for Preventing Adverse drug REactions

Recruiting

• Conditions: bijwerkingen; Adverse drug reactions

• Registration Number: NL-OMON50620
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 1450

Inclusion Criteria

1. Subject must be >= 18 years old
2. Subject must receive a 1st prescription (meaning no known prescription for
this drug in the preceding 12 months) for a drug of interest (Flecainide,
Propafenon, Codeine, Tramadol, Capecitabine, Fluorouracil, Irinotecan,
Tamoxifen, Tegafur, Acenocoumarol, Clopidrogel , Phenprocoumon, Warfarin,
Citalopram , Escitalopram, Paroxetine, Sertraline, Venlafaxine, Amitriptyline,
Clomipramine, Doxepine, Imipramine, Nortryptiline, Phenytoin, Metoprolol,
Efavirenz, Flucloxacillin, Voriconazole, Aripiprazole, Haloperidol, Pimozide,
Zuclopenthixol, Atorvastatin, Simvastatin, Azathioprine, Mercaptopurine,
Tacrolimus, Thioguanine or Atomoxetine), which is prescribed to them in routine
care.
3. Subject is able and willing to take part and be followed-up for at least 12
weeks
4. Subject is able to donate blood or saliva
5. Subject has signed informed consent

Exclusion Criteria

1. Previous (direct-to-consumer, or clinical) genetic testing for a gene
important to the index drug
2. Pregnancy or lactating
3. Life expectancy estimated to be less than three months by treating clinical
team
4. Duration of index drug total treatment length is planned to be less than
seven consecutive days. A drug whose route of administration changes during the
first seven days (e.g. intravenous to oral flucloxacillin) but whose total
treatment duration is seven days or longer, is still eligible.
5. For inpatients: hospital admission is expected to be less than 72 hours (to
facilitate acting upon the PGX results)
6. Unable to consent to the study
7. Unwilling to take part
8. Subject has no fixed address
9. Subject has no current general practitioner
10. Subject is, in the opinion of the Investigator, not suitable to participate
in the study
11. Patient has existing impaired hepatic or renal function for which a lower
dose or alternate drug selection are already part of current routine care.
This would not apply to any drugs specifically given to manage liver/renal
impairment/transplantation.
12. Estimated glomerular filtration rate (MDRD) of less than 15 ml/min per
1,73m2 in a subject with a functioning graft
13. Patients with advanced liver failure (stage Child-Pugh C)

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified