Validation of drug measurement methods in different body fluids
Validation of Drug Assays in Various Biological Matrices
This study is testing how well a new method can measure drug levels in different body fluids to help ensure accurate results for people taking various medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Liverpool Academic / other |
| Locations | 1 site (Liverpool) |
| Trial ID | NCT02283112 on ClinicalTrials.gov |
What this trial studies
This study focuses on validating the accuracy and precision of drug assays that measure drug concentrations in various biological matrices using high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). It involves collecting samples from different bodily fluids to quantify levels of antimicrobials, antivirals, oral contraceptives, and erectile dysfunction agents. Additionally, samples will be collected from individuals not on these medications to ensure quality control of the assays.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals over 18 years of age who are either receiving or not receiving specific medications.
Not a fit: Patients who are unable to give informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the reliability of drug concentration measurements, leading to better patient management and treatment outcomes.
How similar studies have performed: While this approach is essential for ensuring assay accuracy, similar studies have shown varying degrees of success in validating drug measurement methods.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \> 18 years of age Exclusion Criteria: * Unable to give informed consent
Where this trial is running
Liverpool
- Royal Liverpool University Hospital — Liverpool, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Saye Khoo — University of Liverpool
- Study coordinator: Helen Reynolds
- Email: TherEx-trials@liverpool.ac.uk
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.