<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/NCT03790631</url>
  </required_header>
  <id_info>
    <org_study_id>2018-01830</org_study_id>
    <nct_id>NCT03790631</nct_id>
  </id_info>
  <brief_title>The OPTIMAL TDM Study: Determining Optimal Beta-lactam Plasma Concentrations Through Therapeutic Drug Monitoring</brief_title>
  <acronym>OPTIMAL TDM</acronym>
  <official_title>The OPTIMAL TDM Study: Determining Optimal Beta-lactam Plasma Concentrations Through Therapeutic Drug Monitoring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Geneva, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Geneva, Switzerland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Little is known of beta-lactam antibiotics' true therapeutic plasma concentration range. The&#xD;
      aims of this study are to define evidence-based, safe and effective upper and lower limits of&#xD;
      the plasma concentrations of imipenem, meropenem, amoxicillin, flucloxacillin, piperacillin,&#xD;
      ceftazidime and cefepime in patients at increased risk of serious bacterial infections and&#xD;
      currently understudied pharmacokinetics (the critically ill, the elderly, and the&#xD;
      immunosuppressed).&#xD;
&#xD;
      This prospective observational study will include adult patients with suspected or confirmed&#xD;
      systemic bacterial infection receiving one of the above-named antibiotics and hospitalized in&#xD;
      intensive-care, step-down, or hematology-oncology units of the Geneva University Hospitals&#xD;
      (HUG).&#xD;
&#xD;
      Eligible patients will be identified via the electronic health record (EHR). Patients&#xD;
      receiving traditional intermittent dosing or prolonged infusions will undergo TDM for at&#xD;
      least one intermediate (mid-interval) and one trough level at 24 hours (-12 or +48 hours)&#xD;
      after the therapy's start. Patients receiving continuous infusions will undergo TDM for at&#xD;
      least one steady-state level. Clinical course will be observed for 30 days from the start of&#xD;
      the study antibiotic (1st day of study antibiotic =day 1).&#xD;
&#xD;
      The primary outcome is incidence of clinical toxicity through day 30 after start of study&#xD;
      antibiotic (as stratified by BL trough concentration). Secondary outcomes are listed below.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Little is known of beta-lactam antibiotics' true therapeutic plasma concentration range. The&#xD;
      aims of this study are to define evidence-based, safe and effective upper and lower limits of&#xD;
      the plasma concentrations of imipenem, meropenem, amoxicillin, flucloxacillin, piperacillin,&#xD;
      ceftazidime and cefepime in patients at increased risk of serious bacterial infections and&#xD;
      currently understudied pharmacokinetics (the critically ill, the elderly, and the&#xD;
      immunosuppressed).&#xD;
&#xD;
      This prospective observational study will include adult patients with suspected or confirmed&#xD;
      systemic bacterial infection receiving one of the above-named antibiotics and hospitalized in&#xD;
      intensive-care, step-down, or hematology-oncology units of the Geneva University Hospitals&#xD;
      (HUG).&#xD;
&#xD;
      Eligible patients will be identified via the electronic health record (EHR). Patients&#xD;
      receiving traditional intermittent dosing or prolonged infusions will undergo TDM for at&#xD;
      least one intermediate (mid-interval) and one trough level at 24 hours (-12 or +48 hours)&#xD;
      after the therapy's start. Patients receiving continuous infusions will undergo TDM for at&#xD;
      least one steady-state level. Clinical course will be observed for 30 days from the start of&#xD;
      the study antibiotic (1st day of study antibiotic =day 1).&#xD;
&#xD;
      The primary outcome is incidence of clinical toxicity through day 30 after start of study&#xD;
      antibiotic (as stratified by BL trough concentration). Secondary outcomes are listed below.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Incidence of clinical toxicity through day 30 after start of study antibiotic</measure>
    <time_frame>day 30 after start of antibiotic</time_frame>
    <description>Incidence of clinical toxicity through day 30 after start of study antibiotic (as stratified by BL trough concentration)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical response: incidence of clinical cure</measure>
    <time_frame>day 30</time_frame>
    <description>Clinical response to therapy through day 30 will be measured study-wide. &quot;Clinical response&quot; is either clinical cure (resolution of symptoms) or clinical failure (lack of improvement in signs and symptoms of infection OR recurrence of signs/symptoms of infection after initial improvement OR death in the 30-day study period considered at least possibly due to the infection). Where the MIC is unavailable, EUCAST epidemiologic cutoffs (ECOFF) will be used; if no organism is isolated, non-species-related breakpoints for targeted organisms (e.g., Pseudomonas aeruginosa) will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical response in patients with neutropenic fever: incidence of clinical cure in this subpopulation</measure>
    <time_frame>day 30</time_frame>
    <description>Clinical response (as in outcome no. 2) in the subgroup of patients with neutropenic fever at the time of BL therapy. (&quot;Clinical response&quot; is either clinical cure (resolution of symptoms) or clinical failure (lack of improvement in signs and symptoms of infection OR recurrence of signs/symptoms of infection after initial improvement OR death in the 30-day study period considered at least possibly due to the infection).)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day mortality attributable to the treated infection</measure>
    <time_frame>day 30</time_frame>
    <description>30-day mortality attributable to the treated infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day all-cause mortality</measure>
    <time_frame>day 30</time_frame>
    <description>30-day all-cause mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of reversible toxicity</measure>
    <time_frame>day 30</time_frame>
    <description>Proportion of adverse events (AE) that are reversible after discontinuation of the relevant BL antibiotic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Clostridium difficile infection</measure>
    <time_frame>day 30</time_frame>
    <description>Incidence of Clostridium difficile infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinical toxicity of piperacillin-tazobactam when co-administered with vancomycin</measure>
    <time_frame>day 30</time_frame>
    <description>Incidence of clinical toxicity of piperacillin-tazobactam (and other beta-lactam antibiotics) when co-administered with vancomycin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of emergence of resistance</measure>
    <time_frame>day 30</time_frame>
    <description>Prevalence of emerging resistance to study antibiotics in clinical isolates (from baseline)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of undetectable beta-lactam plasma concentrations</measure>
    <time_frame>day 30</time_frame>
    <description>Proportion of patients with undetectable beta-lactam trough and/or intermediate concentrations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of off-label prescribing</measure>
    <time_frame>day 30</time_frame>
    <description>Proportion of patients for whom (a) beta-lactam dosing is &quot;off-label&quot; according to Swiss recommendations and (b) there are no dosing recommendations (e.g., hemofiltration)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The correlation of free versus total flucloxacillin concentrations</measure>
    <time_frame>day 30</time_frame>
    <description>The correlation of free versus total flucloxacillin concentrations (in a subset of patients, free flucloxacillin plasma levels will also be measured and compared to those of total flucloxacillin).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median intermediate and trough plasma concentrations of tazobactam</measure>
    <time_frame>through day 30</time_frame>
    <description>In a subset of patients receiving piperacillin/tazobactam, median intermediate and trough plasma concentrations of tazobactam (beta-lactamase inhibitor) in proportion to piperacillin in patients receiving piperacillin-tazobactam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beta-lactam trough concentration/minimal inhibitory concentration (MIC) index</measure>
    <time_frame>day 1 (±1)</time_frame>
    <description>The trough beta-lactam (BL) concentration/minimal inhibitory concentration (MIC) index on day 1 (±1) will be measured in all patients for later correlation analyses with clinical outcomes (clinical success versus failure).</description>
  </secondary_outcome>
  <number_of_groups>7</number_of_groups>
  <enrollment type="Anticipated">700</enrollment>
  <condition>Beta-lactam Antibiotics</condition>
  <condition>Therapeutic Drug Monitoring</condition>
  <condition>Toxicity</condition>
  <condition>Efficacy</condition>
  <condition>Imipenem</condition>
  <condition>Meropenem</condition>
  <condition>Piperacillin</condition>
  <condition>Flucloxacillin</condition>
  <condition>Amoxicillin</condition>
  <condition>Ceftazidime</condition>
  <condition>Cefepime</condition>
  <arm_group>
    <arm_group_label>imipenem TDM</arm_group_label>
    <description>Adult patients receiving imipenem for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>meropenem TDM</arm_group_label>
    <description>Adult patients receiving meropenem for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>piperacillin TDM</arm_group_label>
    <description>Adult patients receiving piperacillin (with or without tazobactam) for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>flucloxacillin TDM</arm_group_label>
    <description>Adult patients receiving flucloxacillin for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>amoxicillin TDM</arm_group_label>
    <description>Adult patients receiving amoxicillin for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ceftazidime TDM</arm_group_label>
    <description>Adult patients receiving ceftazidime for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cefepime TDM</arm_group_label>
    <description>Adult patients receiving cefepime for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The study is observational.</intervention_name>
    <description>The study is observational.</description>
    <arm_group_label>amoxicillin TDM</arm_group_label>
    <arm_group_label>cefepime TDM</arm_group_label>
    <arm_group_label>ceftazidime TDM</arm_group_label>
    <arm_group_label>flucloxacillin TDM</arm_group_label>
    <arm_group_label>imipenem TDM</arm_group_label>
    <arm_group_label>meropenem TDM</arm_group_label>
    <arm_group_label>piperacillin TDM</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Included patients will be adults (≤18 years) hospitalized in the intensive-care, step-down,&#xD;
        or hematology-oncology units of the Geneva University Hospitals and treated with one of the&#xD;
        above-listed 7 beta-lactam antibiotics for a suspected or confirmed bacterial infections.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Hospitalized patients with suspected or confirmed systemic bacterial infection:&#xD;
&#xD;
          1. Receiving either imipenem-cilastatin, meropenem, amoxicillin (±clavulanic acid),&#xD;
             flucloxacillin, piperacillin-tazobactam, ceftazidime or cefepime&#xD;
&#xD;
          2. Aged ≥18 years&#xD;
&#xD;
          3. Requiring intensive or intermediate-intensive (step-down) care OR severely&#xD;
             immunosuppressed (see definitions)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Planned imminent transfer to an outside hospital&#xD;
&#xD;
          2. Poor prognosis with life expectancy &lt;1 week and/or intended transition to palliative&#xD;
             care&#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_contact>
    <last_name>Angela Huttner, MD</last_name>
    <phone>+41 79 553 3396</phone>
    <email>angela.huttner@hcuge.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dionysios Neofytos, MD</last_name>
    <phone>+41 79 553 3211</phone>
    <email>Dionysios.Neofytos@hcuge.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Geneva University Hospitals</name>
      <address>
        <city>Geneva</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Angela Huttner, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <results_reference>
    <citation>Bricheux A, Lenggenhager L, Hughes S, Karmime A, Lescuyer P, Huttner A. Therapeutic drug monitoring of imipenem and the incidence of toxicity and failure in hospitalized patients: a retrospective cohort study. Clin Microbiol Infect. 2019 Mar;25(3):383.e1-383.e4. doi: 10.1016/j.cmi.2018.11.020. Epub 2018 Dec 4.</citation>
    <PMID>30528370</PMID>
  </results_reference>
  <results_reference>
    <citation>Huwyler T, Lenggenhager L, Abbas M, Ing Lorenzini K, Hughes S, Huttner B, Karmime A, Uckay I, von Dach E, Lescuyer P, Harbarth S, Huttner A. Cefepime plasma concentrations and clinical toxicity: a retrospective cohort study. Clin Microbiol Infect. 2017 Jul;23(7):454-459. doi: 10.1016/j.cmi.2017.01.005. Epub 2017 Jan 19.</citation>
    <PMID>28111294</PMID>
  </results_reference>
  <results_reference>
    <citation>Muller AE, Huttner B, Huttner A. Therapeutic Drug Monitoring of Beta-Lactams and Other Antibiotics in the Intensive Care Unit: Which Agents, Which Patients and Which Infections? Drugs. 2018 Mar;78(4):439-451. doi: 10.1007/s40265-018-0880-z.</citation>
    <PMID>29476349</PMID>
  </results_reference>
  <results_reference>
    <citation>Huttner A, Harbarth S, Hope WW, Lipman J, Roberts JA. Therapeutic drug monitoring of the beta-lactam antibiotics: what is the evidence and which patients should we be using it for? J Antimicrob Chemother. 2015 Dec;70(12):3178-83. doi: 10.1093/jac/dkv201. Epub 2015 Jul 17.</citation>
    <PMID>26188037</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Geneva, Switzerland</investigator_affiliation>
    <investigator_full_name>Angela HUTTNER</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data may be housed in a publicly accessible, non-profit digital repository such as Dryad or EUDAT.</ipd_description>
  </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/NCT03790631
org study id: 2018-01830
nct id: NCT03790631
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Little is known of beta-lactam antibiotics' true therapeutic plasma concentration range. The
      aims of this study are to define evidence-based, safe and effective upper and lower limits of
      the plasma concentrations of imipenem, meropenem, amoxicillin, flucloxacillin, piperacillin,
      ceftazidime and cefepime in patients at increased risk of serious bacterial infections and
      currently understudied pharmacokinetics (the critically ill, the elderly, and the
      immunosuppressed).

      This prospective observational study will include adult patients with suspected or confirmed
      systemic bacterial infection receiving one of the above-named antibiotics and hospitalized in
      intensive-care, step-down, or hematology-oncology units of the Geneva University Hospitals
      (HUG).

      Eligible patients will be identified via the electronic health record (EHR). Patients
      receiving traditional intermittent dosing or prolonged infusions will undergo TDM for at
      least one intermediate (mid-interval) and one trough level at 24 hours (-12 or +48 hours)
      after the therapy's start. Patients receiving continuous infusions will undergo TDM for at
      least one steady-state level. Clinical course will be observed for 30 days from the start of
      the study antibiotic (1st day of study antibiotic =day 1).

      The primary outcome is incidence of clinical toxicity through day 30 after start of study
      antibiotic (as stratified by BL trough concentration). Secondary outcomes are listed below.
Little is known of beta-lactam antibiotics' true therapeutic plasma concentration range. The
      aims of this study are to define evidence-based, safe and effective upper and lower limits of
      the plasma concentrations of imipenem, meropenem, amoxicillin, flucloxacillin, piperacillin,
      ceftazidime and cefepime in patients at increased risk of serious bacterial infections and
      currently understudied pharmacokinetics (the critically ill, the elderly, and the
      immunosuppressed).

      This prospective observational study will include adult patients with suspected or confirmed
      systemic bacterial infection receiving one of the above-named antibiotics and hospitalized in
      intensive-care, step-down, or hematology-oncology units of the Geneva University Hospitals
      (HUG).

      Eligible patients will be identified via the electronic health record (EHR). Patients
      receiving traditional intermittent dosing or prolonged infusions will undergo TDM for at
      least one intermediate (mid-interval) and one trough level at 24 hours (-12 or +48 hours)
      after the therapy's start. Patients receiving continuous infusions will undergo TDM for at
      least one steady-state level. Clinical course will be observed for 30 days from the start of
      the study antibiotic (1st day of study antibiotic =day 1).

      The primary outcome is incidence of clinical toxicity through day 30 after start of study
      antibiotic (as stratified by BL trough concentration). Secondary outcomes are listed below.
observational model: Cohort
time perspective: Prospective
measure: Incidence of clinical toxicity through day 30 after start of study antibiotic
time frame: day 30 after start of antibiotic
description: Incidence of clinical toxicity through day 30 after start of study antibiotic (as stratified by BL trough concentration)
measure: Clinical response: incidence of clinical cure
time frame: day 30
description: Clinical response to therapy through day 30 will be measured study-wide. "Clinical response" is either clinical cure (resolution of symptoms) or clinical failure (lack of improvement in signs and symptoms of infection OR recurrence of signs/symptoms of infection after initial improvement OR death in the 30-day study period considered at least possibly due to the infection). Where the MIC is unavailable, EUCAST epidemiologic cutoffs (ECOFF) will be used; if no organism is isolated, non-species-related breakpoints for targeted organisms (e.g., Pseudomonas aeruginosa) will be used.
measure: clinical response in patients with neutropenic fever: incidence of clinical cure in this subpopulation
time frame: day 30
description: Clinical response (as in outcome no. 2) in the subgroup of patients with neutropenic fever at the time of BL therapy. ("Clinical response" is either clinical cure (resolution of symptoms) or clinical failure (lack of improvement in signs and symptoms of infection OR recurrence of signs/symptoms of infection after initial improvement OR death in the 30-day study period considered at least possibly due to the infection).)
measure: 30-day mortality attributable to the treated infection
time frame: day 30
description: 30-day mortality attributable to the treated infection
measure: 30-day all-cause mortality
time frame: day 30
description: 30-day all-cause mortality
measure: incidence of reversible toxicity
time frame: day 30
description: Proportion of adverse events (AE) that are reversible after discontinuation of the relevant BL antibiotic
measure: Incidence of Clostridium difficile infection
time frame: day 30
description: Incidence of Clostridium difficile infection
measure: Incidence of clinical toxicity of piperacillin-tazobactam when co-administered with vancomycin
time frame: day 30
description: Incidence of clinical toxicity of piperacillin-tazobactam (and other beta-lactam antibiotics) when co-administered with vancomycin
measure: Incidence of emergence of resistance
time frame: day 30
description: Prevalence of emerging resistance to study antibiotics in clinical isolates (from baseline)
measure: Incidence of undetectable beta-lactam plasma concentrations
time frame: day 30
description: Proportion of patients with undetectable beta-lactam trough and/or intermediate concentrations
measure: Incidence of off-label prescribing
time frame: day 30
description: Proportion of patients for whom (a) beta-lactam dosing is "off-label" according to Swiss recommendations and (b) there are no dosing recommendations (e.g., hemofiltration)
measure: The correlation of free versus total flucloxacillin concentrations
time frame: day 30
description: The correlation of free versus total flucloxacillin concentrations (in a subset of patients, free flucloxacillin plasma levels will also be measured and compared to those of total flucloxacillin).
measure: Median intermediate and trough plasma concentrations of tazobactam
time frame: through day 30
description: In a subset of patients receiving piperacillin/tazobactam, median intermediate and trough plasma concentrations of tazobactam (beta-lactamase inhibitor) in proportion to piperacillin in patients receiving piperacillin-tazobactam
measure: Beta-lactam trough concentration/minimal inhibitory concentration (MIC) index
time frame: day 1 (±1)
description: The trough beta-lactam (BL) concentration/minimal inhibitory concentration (MIC) index on day 1 (±1) will be measured in all patients for later correlation analyses with clinical outcomes (clinical success versus failure).
arm group label: imipenem TDM
description: Adult patients receiving imipenem for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state.
arm group label: meropenem TDM
description: Adult patients receiving meropenem for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state.
arm group label: piperacillin TDM
description: Adult patients receiving piperacillin (with or without tazobactam) for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state.
arm group label: flucloxacillin TDM
description: Adult patients receiving flucloxacillin for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state.
arm group label: amoxicillin TDM
description: Adult patients receiving amoxicillin for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state.
arm group label: ceftazidime TDM
description: Adult patients receiving ceftazidime for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state.
arm group label: cefepime TDM
description: Adult patients receiving cefepime for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state.
intervention type: Other
intervention name: The study is observational.
description: The study is observational.
arm group label: amoxicillin TDM
arm group label: cefepime TDM
arm group label: ceftazidime TDM
arm group label: flucloxacillin TDM
arm group label: imipenem TDM
arm group label: meropenem TDM
arm group label: piperacillin TDM
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Angela Huttner, MD
phone: +41 79 553 3396
email: angela.huttner@hcuge.ch
last name: Dionysios Neofytos, MD
phone: +41 79 553 3211
email: Dionysios.Neofytos@hcuge.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
citation: Bricheux A, Lenggenhager L, Hughes S, Karmime A, Lescuyer P, Huttner A. Therapeutic drug monitoring of imipenem and the incidence of toxicity and failure in hospitalized patients: a retrospective cohort study. Clin Microbiol Infect. 2019 Mar;25(3):383.e1-383.e4. doi: 10.1016/j.cmi.2018.11.020. Epub 2018 Dec 4.
PMID: 30528370
citation: Huwyler T, Lenggenhager L, Abbas M, Ing Lorenzini K, Hughes S, Huttner B, Karmime A, Uckay I, von Dach E, Lescuyer P, Harbarth S, Huttner A. Cefepime plasma concentrations and clinical toxicity: a retrospective cohort study. Clin Microbiol Infect. 2017 Jul;23(7):454-459. doi: 10.1016/j.cmi.2017.01.005. Epub 2017 Jan 19.
PMID: 28111294
citation: Muller AE, Huttner B, Huttner A. Therapeutic Drug Monitoring of Beta-Lactams and Other Antibiotics in the Intensive Care Unit: Which Agents, Which Patients and Which Infections? Drugs. 2018 Mar;78(4):439-451. doi: 10.1007/s40265-018-0880-z.
PMID: 29476349
citation: Huttner A, Harbarth S, Hope WW, Lipman J, Roberts JA. Therapeutic drug monitoring of the beta-lactam antibiotics: what is the evidence and which patients should we be using it for? J Antimicrob Chemother. 2015 Dec;70(12):3178-83. doi: 10.1093/jac/dkv201. Epub 2015 Jul 17.
PMID: 26188037
responsible party type: Principal Investigator
investigator affiliation: University of Geneva, Switzerland
investigator full name: Angela HUTTNER
investigator title: Principal Investigator
sharing ipd: Undecided
ipd description: Data may be housed in a publicly accessible, non-profit digital repository such as Dryad or EUDAT.