Validation of Drug Assays in Various Biological Matrices

• Sponsor: Helen Reynolds (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02283112
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 95
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

This study aims to ensure that assays that measure drug concentrations are accurate and precise in different matrices when quantified using high performance liquid chromatography -tandem mass spectrometry (HPLC-MS/MS). The study involves collecting samples of various bodily fluids to quantify antimicrobials, antivirals, oral contraceptives and erectile dysfunction agents. Samples will also be obtained from individuals not receiving these medications for quality control purposes.

Condition or Disease	Intervention/Treatment	Phase
Infection	Other: antivirals, antimicrobials, oral contraceptive, erectile dysfunction agents

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Validation of Drug Assays in Various Biological Matrices
• Study Start Date: Oct 1, 2014
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Outcome Measures

Primary Outcome Measures

1. To measure drug concentrations using high performance liquid chromatography -tandem mass spectrometry (HPLC-MS/MS) (accuracy and precision of assays that measure drug concentrations) [Follow up up to 5 years]

   Assay validation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 18 years of age

Exclusion Criteria:

• Unable to give informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal Liverpool & Broadgreen Univeristy Hospitals NHS Trust	Liverpool		United Kingdom	L7 8XP

Sponsors and Collaborators

• Helen Reynolds

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Helen Reynolds, Research nurse, University of Liverpool
• ClinicalTrials.gov Identifier: NCT02283112
• Other Study ID Numbers: RLUH 4520
• First Posted: Nov 5, 2014
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Additional relevant MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents; Antiviral Agents; Contraceptive Agents; Contraceptives, Oral

Study Results

No Results Posted as of Aug 9, 2022