<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02966977</url>
  </required_header>
  <id_info>
    <org_study_id>2016-01534</org_study_id>
    <nct_id>NCT02966977</nct_id>
  </id_info>
  <brief_title>Extending Urine Analysis By Direct Mass Spectrometry</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the effect of an extension of conventional urine&#xD;
      diagnostics with mass spectrometry in patients with a suspected UTI. Mass spectrometry is&#xD;
      done directly from the urine sample (without an intermediate bacterial culture).The primary&#xD;
      outcome is the time from the entry of a urine sample in the microbiological laboratory to the&#xD;
      adequate/optimal/definitive treatment. Secondary outcomes are the time to diagnosis of a&#xD;
      therapy relevant UTI, the quantity of antibiotics prescribed per patient and ward and a&#xD;
      comparison of the length of hospital stay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Urinary tract infections (UTI) have a high incidence rate and are one of the main reasons for&#xD;
      initiating an antibiotic therapy, both, in the ambulatory and hospital setting. Mass&#xD;
      spectrometry and improved sample preparation allows same-day identification of the causing&#xD;
      agent of an UTI. This could shorten the time of suboptimal and potentially harmful empirical&#xD;
      therapy. Additionally adverse effects from and the development of resistance against the&#xD;
      applied antibiotic agent could be diminished. Matrix Assisted Laser Desorption Ionization&#xD;
      (MALDI)- Time of Flight (TOF) Mass Spectrometry (MS) (MALDI-TOF MS) is already the preferred&#xD;
      identification method in an increasing number of laboratories since it outperforms&#xD;
      biochemical identification by speed and precision. This study tries to evaluate this new&#xD;
      method to identify the causing agent of an UTI and evaluates its clinical implications.&#xD;
&#xD;
      This research project is a clinical trial that intends to analyse urine of patients with&#xD;
      suspected urinary tract infections by mass spectrometry. This patient material is&#xD;
      conventionally processed and not retrieved particularly for study purposes. Health-related&#xD;
      personal data is collected from patients on the wards of the Clinic for Internal Medicine at&#xD;
      the University Hospital Basel that have a urine sample analysed during the study period. No&#xD;
      health-related personal data is particularly collected for this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2016</start_date>
  <completion_date type="Actual">April 15, 2017</completion_date>
  <primary_completion_date type="Actual">March 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time from the entry of a urine sample in the microbiological laboratory to the adequate/optimal/definitive treatment.</measure>
    <time_frame>1 week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to diagnosis of a therapy relevant UTI.</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantity of antibiotics prescribed per patient and ward.</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the length of hospital stay</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of the number of possible complications connected to UTI</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">192</enrollment>
  <condition>Urinary Tract Infection (Diagnosis)</condition>
  <arm_group>
    <arm_group_label>Conventional microbiological diagnostics</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional microbiological identification by culture plate (overnight cultures with subsequent bacterial/fungal identification).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional plus mass spectrometry</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conventional microbiological identification by culture plate plus Direct mass spectrometry identification from urine sample. This additional diagnostic procedure is supplied additionally to conventional diagnostics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional microbiological identification by culture plate</intervention_name>
    <description>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.</description>
    <arm_group_label>Conventional microbiological diagnostics</arm_group_label>
    <arm_group_label>Conventional plus mass spectrometry</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Direct mass spectrometry identification from urine sample</intervention_name>
    <description>The urine sample is concentrated and directly measured by a MALDI-TOF mass spectrometer without an intermediary microbiological culture on agar plates.</description>
    <arm_group_label>Conventional plus mass spectrometry</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of the Clinic for Internal Medicine at the University Hospital Basel with a&#xD;
             suspected UTI and a minimum of one urine sample sent to the clinical microbiology&#xD;
             laboratory.&#xD;
&#xD;
        Additionally at least one of the following:&#xD;
&#xD;
          -  Patients consented to the general (i.e. &quot;hospital-wide&quot;) use of their data and samples&#xD;
             for research purposes.&#xD;
&#xD;
          -  Patients consented to be enrolled in this study (by being informed about this study&#xD;
             and signing the study specific consent form).&#xD;
&#xD;
          -  Patients who are exempted from the need for a consent by way of an exception in&#xD;
             agreement to the decisions of the competent ethics committee.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minors or persons who declined the general use of their data and samples for research&#xD;
             purposes (hospital wide consent) and declined or did not decide on the study specific&#xD;
             consent form are not included.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adrian Egli, PD Dr. FAMH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Microbiology, University Hospital Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Tract Infections</mesh_term>
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02966977
org study id: 2016-01534
nct id: NCT02966977
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Time from the entry of a urine sample in the microbiological laboratory to the adequate/optimal/definitive treatment.
time frame: 1 week
measure: Time to diagnosis of a therapy relevant UTI.
time frame: 1 week
measure: Quantity of antibiotics prescribed per patient and ward.
time frame: 2 weeks
measure: Comparison of the length of hospital stay
time frame: 2 weeks
measure: Comparison of the number of possible complications connected to UTI
time frame: 4 weeks
arm group label: Conventional microbiological diagnostics
arm group type: Active Comparator
description: Conventional microbiological identification by culture plate (overnight cultures with subsequent bacterial/fungal identification).
arm group label: Conventional plus mass spectrometry
arm group type: Experimental
description: Conventional microbiological identification by culture plate plus Direct mass spectrometry identification from urine sample. This additional diagnostic procedure is supplied additionally to conventional diagnostics.
intervention type: Other
intervention name: Conventional microbiological identification by culture plate
description: 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.
arm group label: Conventional microbiological diagnostics
arm group label: Conventional plus mass spectrometry
intervention type: Other
intervention name: Direct mass spectrometry identification from urine sample
description: The urine sample is concentrated and directly measured by a MALDI-TOF mass spectrometer without an intermediary microbiological culture on agar plates.
arm group label: Conventional plus mass spectrometry
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Adrian Egli, PD Dr. FAMH
role: Principal Investigator
affiliation: Clinical Microbiology, University Hospital Basel
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Urinary Tract Infections
mesh term: Infections
sharing ipd: No