xml: <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/NCT05971979</url>
    </required_header>
    <id_info>
      <org_study_id>B01949</org_study_id>
      <nct_id>NCT05971979</nct_id>
    </id_info>
    <brief_title>Therapeutic Drug Monitoring - Targeting IMproved Effectiveness</brief_title>
    <acronym>TDM-TIME</acronym>
    <official_title>Therapeutic Drug Monitoring - Targeting Improved Effectiveness (TDM-TIME): An Observational Study of Turnaround Time for Therapeutic Drug Monitoring of Antimicrobial Agents in Critically Ill Patients With Respiratory Sepsis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jan Hansel</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Manchester University NHS Foundation Trust</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Severe infections can be caused by various organisms, such as bacteria or viruses, and lead&#xD;
        to otherwise healthy people getting very unwell, sometimes needing treatment in hospital or&#xD;
        even intensive care. For the treatment of bacterial infections to be successful, the correct&#xD;
        antibiotics need to be given promptly. Early in the course of illness, clinicians often do&#xD;
        not know exactly which bacteria are causing the infection. Furthermore, patients differ in&#xD;
        terms of how their bodies process the antibiotics they are given; this means that some may&#xD;
        get too much and others too little. This can in turn lead to some patients not being fully&#xD;
        cured, and others coming to harm due to side effects of higher doses of these drugs.&#xD;
  &#xD;
        For certain types of antibiotics, clinicians are able to measure their levels in the&#xD;
        bloodstream, which can help guide dosing. This is called therapeutic drug monitoring, and is&#xD;
        commonly used in clinical practice. One of the problems with therapeutic drug monitoring is&#xD;
        that it is often not available outside of regular working hours, is costly, and most&#xD;
        importantly, provides clinicians with useful information only after a few days of treatment&#xD;
        have already been completed. This may be too late to treat these severely ill patients with&#xD;
        life-threatening infections, where early and appropriate treatments matter.&#xD;
  &#xD;
        The aim of our study, called TDM-TIME, is to look at how long it takes for blood samples to&#xD;
        get from the patient to the laboratory to be measured, with the results then communicated&#xD;
        back to clinicians. We are further looking to investigate whether steps can be taken to&#xD;
        improve these timings, which would lead to shorter times until treatments can be improved. As&#xD;
        our study is observational, we will not change anything about the treatment of our patients,&#xD;
        but will only be measuring levels of antibiotics in their blood.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Availability of LC-MS/MS results within two dose intervals of antimicrobial (dichotomous)</measure>
      <time_frame>48 hours</time_frame>
      <description>Proportion of participants within timeframe for antimicrobial</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time elapsed from peripheral blood collection to LC-MS/MS result availability</measure>
      <time_frame>48 hours</time_frame>
      <description>Mean time required for result availability</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time elapsed from first dose of antimicrobial to LC-MS/MS result availability</measure>
      <time_frame>72 hours</time_frame>
      <description>Mean time required for result availability from first antimicrobial dose administration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of pre-analytical stage</measure>
      <time_frame>24 hours</time_frame>
      <description>Mean time required for pre-analytical stage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of analytical stage</measure>
      <time_frame>24 hours</time_frame>
      <description>Mean time required for analytical stage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of post-analytical stage</measure>
      <time_frame>24 hours</time_frame>
      <description>Mean time required for post-analytical stage</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Therapeutic target attainment (100% fT&gt;4xMIC)</measure>
      <time_frame>72 hours</time_frame>
      <description>Proportion of patients attaining target (100% fT&gt;4xMIC)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>28-day mortality</measure>
      <time_frame>28 days</time_frame>
      <description>Proportion of patients alive at 28 days from enrolment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ICU length of stay</measure>
      <time_frame>28 days</time_frame>
      <description>Number of days from ICU admission to discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital length of stay</measure>
      <time_frame>28 days</time_frame>
      <description>Number of days from hospital admission to discharge</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Pneumonia</condition>
    <condition>Sepsis</condition>
    <condition>Infection, Bacterial</condition>
    <arm_group>
      <arm_group_label>Critically ill patients with presumed or confirmed lower respiratory tract infection</arm_group_label>
      <description>Non-interventional. Admitted to intensive care unit. Presumed or confirmed lower respiratory tract infection. Receiving either piperacillin/tazobactam or meropenem. Participants will have samples collected during an antimicrobial dose cycle.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No intervention</intervention_name>
      <description>No intervention</description>
      <arm_group_label>Critically ill patients with presumed or confirmed lower respiratory tract infection</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Peripheral blood&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          All individuals will be considered for inclusion in this study regardless of age,&#xD;
          disability, gender reassignment, marriage and civil partnership, pregnancy and maternity,&#xD;
          race, religion and belief, sex, and sexual orientation except where the study inclusion and&#xD;
          exclusion criteria explicitly state otherwise.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt; 18 years;&#xD;
  &#xD;
            -  Admitted to intensive care;&#xD;
  &#xD;
            -  Treated for presumed or confirmed lower respiratory tract infection;&#xD;
  &#xD;
            -  Receiving OR about to receive the first dose of intravenous antimicrobials (either&#xD;
               meropenem of piperacillin/tazobactam);&#xD;
  &#xD;
            -  Valid informed consent OR enrolment through deferred consent appropriate.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe anaemia (haemoglobin level &lt; 70 g/L);&#xD;
  &#xD;
            -  Unlikely to survive 24 hours as judged by the treating physician;&#xD;
  &#xD;
            -  Study antimicrobial course started more than 24 hours ago.&#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>Jan Hansel, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Manchester</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lynne Webster</last_name>
      <phone>+441617015057</phone>
      <email>research.sponsor@mft.nhs.uk</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Manchester University NHS Foundation Trust</investigator_affiliation>
      <investigator_full_name>Jan Hansel</investigator_full_name>
      <investigator_title>Academic Clinical Fellow in Intensive Care Medicine</investigator_title>
    </responsible_party>
    <keyword>drug monitoring</keyword>
    <keyword>sepsis</keyword>
    <keyword>antibacterial agents</keyword>
    <keyword>respiratory tract infections</keyword>
    <keyword>antimicrobial stewardship</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sepsis</mesh_term>
      <mesh_term>Bacterial Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971979
  org study id: B01949
  nct id: NCT05971979
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Severe infections can be caused by various organisms, such as bacteria or viruses, and lead
        to otherwise healthy people getting very unwell, sometimes needing treatment in hospital or
        even intensive care. For the treatment of bacterial infections to be successful, the correct
        antibiotics need to be given promptly. Early in the course of illness, clinicians often do
        not know exactly which bacteria are causing the infection. Furthermore, patients differ in
        terms of how their bodies process the antibiotics they are given; this means that some may
        get too much and others too little. This can in turn lead to some patients not being fully
        cured, and others coming to harm due to side effects of higher doses of these drugs.
  
        For certain types of antibiotics, clinicians are able to measure their levels in the
        bloodstream, which can help guide dosing. This is called therapeutic drug monitoring, and is
        commonly used in clinical practice. One of the problems with therapeutic drug monitoring is
        that it is often not available outside of regular working hours, is costly, and most
        importantly, provides clinicians with useful information only after a few days of treatment
        have already been completed. This may be too late to treat these severely ill patients with
        life-threatening infections, where early and appropriate treatments matter.
  
        The aim of our study, called TDM-TIME, is to look at how long it takes for blood samples to
        get from the patient to the laboratory to be measured, with the results then communicated
        back to clinicians. We are further looking to investigate whether steps can be taken to
        improve these timings, which would lead to shorter times until treatments can be improved. As
        our study is observational, we will not change anything about the treatment of our patients,
        but will only be measuring levels of antibiotics in their blood.
  observational model: Cohort
  time perspective: Prospective
  measure: Availability of LC-MS/MS results within two dose intervals of antimicrobial (dichotomous)
  time frame: 48 hours
  description: Proportion of participants within timeframe for antimicrobial
  measure: Time elapsed from peripheral blood collection to LC-MS/MS result availability
  time frame: 48 hours
  description: Mean time required for result availability
  measure: Time elapsed from first dose of antimicrobial to LC-MS/MS result availability
  time frame: 72 hours
  description: Mean time required for result availability from first antimicrobial dose administration
  measure: Duration of pre-analytical stage
  time frame: 24 hours
  description: Mean time required for pre-analytical stage
  measure: Duration of analytical stage
  time frame: 24 hours
  description: Mean time required for analytical stage
  measure: Duration of post-analytical stage
  time frame: 24 hours
  description: Mean time required for post-analytical stage
  measure: Therapeutic target attainment (100% fT>4xMIC)
  time frame: 72 hours
  description: Proportion of patients attaining target (100% fT>4xMIC)
  measure: 28-day mortality
  time frame: 28 days
  description: Proportion of patients alive at 28 days from enrolment
  measure: ICU length of stay
  time frame: 28 days
  description: Number of days from ICU admission to discharge
  measure: Hospital length of stay
  time frame: 28 days
  description: Number of days from hospital admission to discharge
  arm group label: Critically ill patients with presumed or confirmed lower respiratory tract infection
  description: Non-interventional. Admitted to intensive care unit. Presumed or confirmed lower respiratory tract infection. Receiving either piperacillin/tazobactam or meropenem. Participants will have samples collected during an antimicrobial dose cycle.
  intervention type: Other
  intervention name: No intervention
  description: No intervention
  arm group label: Critically ill patients with presumed or confirmed lower respiratory tract infection
  Peripheral blood
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jan Hansel, MD
  role: Principal Investigator
  affiliation: University of Manchester
  last name: Lynne Webster
  phone: +441617015057
  email: research.sponsor@mft.nhs.uk
  responsible party type: Sponsor-Investigator
  investigator affiliation: Manchester University NHS Foundation Trust
  investigator full name: Jan Hansel
  investigator title: Academic Clinical Fellow in Intensive Care Medicine
  mesh term: Sepsis
  mesh term: Bacterial Infections
  sharing ipd: Undecided