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Extending Urine Analysis By Direct Mass Spectrometry

NCT02966977 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2020-07-17

No results posted yet for this study

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 culture).The primary outcome is the time from the entry of a urine sample in the microbiological laboratory to the adequate/optimal/definitive 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.

Conditions

  • Urinary Tract Infection (Diagnosis)

Interventions

OTHER

Conventional microbiological identification by culture plate

Conventional microbiological identification involves a step of overnight-2days growth of bacteria/fungi on culture plates prior to identification by biochemical methods or by mass spectrometry. See also information noted in arm/group description.

OTHER

Direct mass spectrometry identification from urine sample

The urine sample is concentrated and directly measured by a MALDI-TOF mass spectrometer without an intermediary microbiological culture on agar plates.

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Adrian Egli, PD Dr. FAMH · Clinical Microbiology, University Hospital Basel

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-03
Primary Completion
2017-03-31
Completion
2017-04-15

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02966977 on ClinicalTrials.gov