Extending Urine Analysis By Direct Mass Spectrometry

NCT02966977 | Completed

• 1 other identifier: 2016-01534
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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 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)

Outcome Measures

Primary Outcomes (1)

• Time from the entry of a urine sample in the microbiological laboratory to the adequate/optimal/definitive treatment.

  1 week

Secondary Outcomes (4)

• Time to diagnosis of a therapy relevant UTI.

  1 week

• Quantity of antibiotics prescribed per patient and ward.

  2 weeks

• Comparison of the length of hospital stay

  2 weeks

• Comparison of the number of possible complications connected to UTI

  4 weeks

Study Arms (2)

Conventional microbiological diagnostics

ACTIVE COMPARATOR

Conventional microbiological identification by culture plate (overnight cultures with subsequent bacterial/fungal identification).

Other: Conventional microbiological identification by culture plate

Conventional plus mass spectrometry

EXPERIMENTAL

Conventional microbiological identification by culture plate plus Direct mass spectrometry identification from urine sample. This additional diagnostic procedure is supplied additionally to conventional diagnostics.

Other: Conventional microbiological identification by culture plate; Other: Direct mass spectrometry identification from urine sample

Interventions

Conventional microbiological identification by culture plate OTHER

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.

Conventional microbiological diagnostics; Conventional plus mass spectrometry

Direct mass spectrometry identification from urine sample OTHER

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

Conventional plus mass spectrometry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of the Clinic for Internal Medicine at the University Hospital Basel with a suspected UTI and a minimum of one urine sample sent to the clinical microbiology laboratory.
• Additionally at least one of the following:
• Patients consented to the general (i.e. "hospital-wide") use of their data and samples for research purposes.
• Patients consented to be enrolled in this study (by being informed about this study and signing the study specific consent form).
• Patients who are exempted from the need for a consent by way of an exception in agreement to the decisions of the competent ethics committee.

You may not qualify if:

• Minors or persons who declined the general use of their data and samples for research purposes (hospital wide consent) and declined or did not decide on the study specific consent form are not included.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Urinary Tract Infections; Disease

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adrian Egli, PD Dr. FAMH

  Clinical Microbiology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 17, 2016
• Study Start: October 3, 2016
• Primary Completion: March 31, 2017
• Study Completion: April 15, 2017
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)