Ignite Creation Date:
2024-05-06 @ 9:23 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02966977
Status:
COMPLETED
Last Update Posted:
2020-07-17
First Post:
2016-11-15
Brief Title:
Extending Urine Analysis By Direct Mass Spectrometry
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Clinical Study To Analyse The Influence Of An Extended Urine Analysis By Mass Spectrometry On Internal Medicine Wards At The University Hospital Of Basel
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to evaluate the effect of an extension of conventional urine diagnostics with mass spectrometry in patients with a suspected UTI Mass spectrometry is done directly from the urine sample without an intermediate bacterial cultureThe primary outcome is the time from the entry of a urine sample in the microbiological laboratory to the adequateoptimaldefinitive treatment Secondary outcomes are the time to diagnosis of a therapy relevant UTI the quantity of antibiotics prescribed per patient and ward and a comparison of the length of hospital stay
Detailed Description:
Urinary tract infections UTI have a high incidence rate and are one of the main reasons for initiating an antibiotic therapy both in the ambulatory and hospital setting Mass spectrometry and improved sample preparation allows same-day identification of the causing agent of an UTI This could shorten the time of suboptimal and potentially harmful empirical therapy Additionally adverse effects from and the development of resistance against the applied antibiotic agent could be diminished Matrix Assisted Laser Desorption Ionization MALDI- Time of Flight TOF Mass Spectrometry MS MALDI-TOF MS is already the preferred identification method in an increasing number of laboratories since it outperforms biochemical identification by speed and precision This study tries to evaluate this new method to identify the causing agent of an UTI and evaluates its clinical implications
This research project is a clinical trial that intends to analyse urine of patients with suspected urinary tract infections by mass spectrometry This patient material is conventionally processed and not retrieved particularly for study purposes Health-related personal data is collected from patients on the wards of the Clinic for Internal Medicine at the University Hospital Basel that have a urine sample analysed during the study period No health-related personal data is particularly collected for this study
This research project is a clinical trial that intends to analyse urine of patients with suspected urinary tract infections by mass spectrometry This patient material is conventionally processed and not retrieved particularly for study purposes Health-related personal data is collected from patients on the wards of the Clinic for Internal Medicine at the University Hospital Basel that have a urine sample analysed during the study period No health-related personal data is particularly collected for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None