<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/NCT04436991</url>
  </required_header>
  <id_info>
    <org_study_id>2017/1369 // BC-01030</org_study_id>
    <nct_id>NCT04436991</nct_id>
  </id_info>
  <brief_title>Antibiotic Dosing in Geriatric Patients at the Emergency Department</brief_title>
  <acronym>AGED</acronym>
  <official_title>Antibiotic Dosing in Geriatric Patients at the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Ghent</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>
      In this pilot study, we will investigate whether - with the current dosing regimens, used in&#xD;
      the Ghent University Hospital - pharmacodynamic targets regarding beta-lactam antibiotics&#xD;
      (more specific Amoxicilline-Clavulanate, Piperacillin-Tazobactam and Temocillin) are attained&#xD;
      in frail patients admitted to the geriatric department.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In drug research studies, older people - and especially patients with a geriatric profile or&#xD;
      frailty risk - are very frequently excluded. Moreover, drug dosing is often extrapolated from&#xD;
      studies in younger adults with failure to consider potential differences in pharmacokinetics&#xD;
      (PK) and pharmacodynamics (PD).&#xD;
&#xD;
      Studies on dosing of beta-lactam antibiotics in geriatric or frail patients aged 75 years or&#xD;
      older have, to the best of our knowledge, never been performed.&#xD;
&#xD;
      In this pilot study, we will investigate whether - with the current dosing regimens, used in&#xD;
      the Ghent University Hospital - pharmacodynamic targets regarding beta-lactam antibiotics&#xD;
      (more specific Amoxicilline-Clavulanate, Piperacillin-Tazobactam and Temocillin) are attained&#xD;
      in frail patients admitted to the geriatric department.&#xD;
&#xD;
      This monocentric, prospective, observational trial is currently ongoing at the emergency&#xD;
      department and geriatric department of the Ghent University Hospital.&#xD;
&#xD;
      Amoxicillin/clavulanic acid 1000/200mg of piperacillin-tazobactam 4000mg or temocillin 2000mg&#xD;
      was infused intravenously over 30 minutes using a syringe pump. The standard dosing regimes&#xD;
      were used.&#xD;
&#xD;
      An infusion catheter of minimum 18-gauge was placed in the contralateral arm to the arm in&#xD;
      which the antibiotic dose was administered. Blood samples were collected from this catheter&#xD;
      at first dose and assumed steady state conditions. Steady state was assumed to be reached&#xD;
      after minimal 24h (&gt; 4 doses at four - six hourly interval) of therapy. The goal was to&#xD;
      obtain 5 first dose and 5 steady dose samples in every patient.&#xD;
&#xD;
      Material for bacteriological analysis, such as blood cultures, urine samples, sputum, were&#xD;
      collected in every patient according to standard care. In case of bacterial growth, MIC's&#xD;
      were measured on the reported strains when possible.&#xD;
&#xD;
      Amoxicillin, clavulanic acid, piperacillin, tazobactam and temocillin were measured using a&#xD;
      validated ultra-performance liquid chromatographic method with tandem mass spectrometric&#xD;
      detection.&#xD;
&#xD;
      Serum creatinine, cystatin C, procalcitonin, infection parameters (CRP, WBC count) and&#xD;
      albumin were obtained from standard blood samples performed in these patients at day one and&#xD;
      also later on during their therapy.&#xD;
&#xD;
      Three frailty score systems (KATZ, Geriatric 8 - G8, Cumulative Illness Rating Scale - CIRS)&#xD;
      were calculated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 3, 2018</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Actual">September 3, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Weeks</target_duration>
  <primary_outcome>
    <measure>Blood concentrations of amoxicillin-clavulanate.</measure>
    <time_frame>Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)</time_frame>
    <description>To investigate whether blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens in first-dose or early-dose conditions and in steady-state conditions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood concentrations of piperacillin-tazobactam.</measure>
    <time_frame>Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)</time_frame>
    <description>To investigate whether blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens in first-dose or early-dose conditions and in steady-state conditions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood concentrations of temocillin.</measure>
    <time_frame>Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)</time_frame>
    <description>To investigate whether blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens in first-dose or early-dose conditions and in steady-state conditions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measured total and unbound concentrations of beta-lactam antibiotics.</measure>
    <time_frame>Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)</time_frame>
    <description>To compare measured total and unbound concentrations of beta-lactam antibiotics with predefined pharmacodynamic targets.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response to antimicrobial therapy.</measure>
    <time_frame>The end of individual antibiotic therapy with an average of 1 week</time_frame>
    <description>To describe therapeutic response to antimicrobial therapy using procalcitonin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Achievement of pharmacodynamic targets measured by questionnaire, vital signs, blood results and side effects.</measure>
    <time_frame>The end of individual antibiotic therapy with an average of 1 week</time_frame>
    <description>To compare achievement of pharmacodynamic targets in early-dose and steady-state conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance of betalactam antibiotics.</measure>
    <time_frame>Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)</time_frame>
    <description>To compare clearance of betalactam antibiotics and correlate with renal function using creatinin clearance en cystatin C.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Elderly Infection</condition>
  <condition>Frailty</condition>
  <condition>Frail Elderly Syndrome</condition>
  <condition>Infection, Bacterial</condition>
  <arm_group>
    <arm_group_label>Amoxicillin-clavulanate</arm_group_label>
    <description>Administration of amoxicillin-clavulanate as standard care therapy (4x or 6x 1g/d). Blood sampling in early and steady state dose (up to 5 samplings per dose). Collection of hemocultures, urine samples and sputum samples when possible.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Piperacillin-tazobactam</arm_group_label>
    <description>Administration of piperacillin-tazobactam as standard care therapy (4x 4g/d). Blood sampling in early and steady state dose (up to 5 samplings per dose). Collection of hemocultures, urine samples and sputum samples when possible.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Temocillin</arm_group_label>
    <description>Administration of temocillin as standard care therapy (2x or 3x 2g/d). Blood sampling in early and steady state dose (up to 5 samplings per dose). Collection of hemocultures, urine samples and sputum samples when possible.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <description>At predefined time points through a venous catheter already in place. Max. volume to be withdrawn: Maximum 4ml/sample. Maximum 10 samples/patient.&#xD;
A last blood sample will be taken, if necessary, after the end of antibiotic therapy, between day 7 and day 14. Though blood results preferably will be used from available data from tests already done during standard treatment.&#xD;
Samples are collected in lithium-heparin tubes (without gel) and centrifuged immediately (within a maximum of 30 minutes after sampling) at room temperature: 8 minutes at 1885g.&#xD;
Plasma is then collected and divided in two separated labelled Eppendorf tubes 1.5 ml and immediately frozen at - 80 °C. If this is not immediately possible, tubes are frozen at - 20 °C and at regular time points transferred to a freezer at - 80 °C (minimum twice a day).</description>
    <arm_group_label>Amoxicillin-clavulanate</arm_group_label>
    <arm_group_label>Piperacillin-tazobactam</arm_group_label>
    <arm_group_label>Temocillin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Sputum sample</intervention_name>
    <description>Bacteriological specimen, such as blood cultures, urine samples, sputum ea., which are usually collected in every patient according to standard care will be retained. If there is bacterial growth, MIC's will be calculated on these strains for study purpose.</description>
    <arm_group_label>Amoxicillin-clavulanate</arm_group_label>
    <arm_group_label>Piperacillin-tazobactam</arm_group_label>
    <arm_group_label>Temocillin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Hemoculture</intervention_name>
    <description>Bacteriological specimen, such as blood cultures, urine samples, sputum ea., which are usually collected in every patient according to standard care will be retained. If there is bacterial growth, MIC's will be calculated on these strains for study purpose.</description>
    <arm_group_label>Amoxicillin-clavulanate</arm_group_label>
    <arm_group_label>Piperacillin-tazobactam</arm_group_label>
    <arm_group_label>Temocillin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Urine sample</intervention_name>
    <description>Bacteriological specimen, such as blood cultures, urine samples, sputum ea., which are usually collected in every patient according to standard care will be retained. If there is bacterial growth, MIC's will be calculated on these strains for study purpose.</description>
    <arm_group_label>Amoxicillin-clavulanate</arm_group_label>
    <arm_group_label>Piperacillin-tazobactam</arm_group_label>
    <arm_group_label>Temocillin</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood, serum, plasma, blood cultures, urine samples, sputum.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Frail elderly patients with a minimum of 75 years old, presenting at the emergency&#xD;
        department and in need for hospitalization at the geriatric ward, in which a betalactam&#xD;
        antibiotic treatment was started.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presenting at the emergency department and later on admitted to the geriatric&#xD;
             department&#xD;
&#xD;
          -  Patient age 75 years or older&#xD;
&#xD;
          -  Patients with geriatric profile according to KATZ scale, G8 screening test or CIRS&#xD;
             score.&#xD;
&#xD;
          -  Patient receiving antibiotic treatment (amoxicillin-clavulanate,&#xD;
             piperacillin-tazobactam)&#xD;
&#xD;
          -  Intravenous access available for blood sampling. For measurement of the peak&#xD;
             concentration an intravenous access other than the drug infusion line is required.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Admission to other units than the geriatric department incl. the ICU.&#xD;
&#xD;
          -  Absence of informed consent&#xD;
&#xD;
          -  Known hypersensitivity to beta-lactam antibiotics&#xD;
&#xD;
          -  Patients who received oral amoxicillin-clavulanate prior to admission will not be&#xD;
             included in the iv. amoxicillin-clavulanate group.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tania Desmet, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Ghent</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peter De Paepe, Prof. Dr.</last_name>
    <phone>003293325211</phone>
    <email>peter.depaepe@uzgent.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tania Desmet, Dr.</last_name>
    <phone>003293321559</phone>
    <email>tania.desmet@uzgent.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital Ghent</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter De Paepe, Prof. Dr.</last_name>
      <phone>003293325211</phone>
      <email>peter.depaepe@uzgent.be</email>
    </contact>
    <contact_backup>
      <last_name>Tania Desmet, Dr.</last_name>
      <phone>003293321559</phone>
      <email>tania.desmet@uzgent.be</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>February 20, 2023</last_update_submitted>
  <last_update_submitted_qc>February 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>amoxicillin</keyword>
  <keyword>piperacillin-tazobactam</keyword>
  <keyword>temocillin</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>pharmacodynamics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Bacterial Infections</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Students participating at the study (registered ethical committee) can consult individual participant data.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>During the whole study course.</ipd_time_frame>
    <ipd_access_criteria>To be approved by ethical committee.</ipd_access_criteria>
  </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/NCT04436991
org study id: 2017/1369 // BC-01030
nct id: NCT04436991
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this pilot study, we will investigate whether - with the current dosing regimens, used in
      the Ghent University Hospital - pharmacodynamic targets regarding beta-lactam antibiotics
      (more specific Amoxicilline-Clavulanate, Piperacillin-Tazobactam and Temocillin) are attained
      in frail patients admitted to the geriatric department.
In drug research studies, older people - and especially patients with a geriatric profile or
      frailty risk - are very frequently excluded. Moreover, drug dosing is often extrapolated from
      studies in younger adults with failure to consider potential differences in pharmacokinetics
      (PK) and pharmacodynamics (PD).

      Studies on dosing of beta-lactam antibiotics in geriatric or frail patients aged 75 years or
      older have, to the best of our knowledge, never been performed.

      In this pilot study, we will investigate whether - with the current dosing regimens, used in
      the Ghent University Hospital - pharmacodynamic targets regarding beta-lactam antibiotics
      (more specific Amoxicilline-Clavulanate, Piperacillin-Tazobactam and Temocillin) are attained
      in frail patients admitted to the geriatric department.

      This monocentric, prospective, observational trial is currently ongoing at the emergency
      department and geriatric department of the Ghent University Hospital.

      Amoxicillin/clavulanic acid 1000/200mg of piperacillin-tazobactam 4000mg or temocillin 2000mg
      was infused intravenously over 30 minutes using a syringe pump. The standard dosing regimes
      were used.

      An infusion catheter of minimum 18-gauge was placed in the contralateral arm to the arm in
      which the antibiotic dose was administered. Blood samples were collected from this catheter
      at first dose and assumed steady state conditions. Steady state was assumed to be reached
      after minimal 24h (> 4 doses at four - six hourly interval) of therapy. The goal was to
      obtain 5 first dose and 5 steady dose samples in every patient.

      Material for bacteriological analysis, such as blood cultures, urine samples, sputum, were
      collected in every patient according to standard care. In case of bacterial growth, MIC's
      were measured on the reported strains when possible.

      Amoxicillin, clavulanic acid, piperacillin, tazobactam and temocillin were measured using a
      validated ultra-performance liquid chromatographic method with tandem mass spectrometric
      detection.

      Serum creatinine, cystatin C, procalcitonin, infection parameters (CRP, WBC count) and
      albumin were obtained from standard blood samples performed in these patients at day one and
      also later on during their therapy.

      Three frailty score systems (KATZ, Geriatric 8 - G8, Cumulative Illness Rating Scale - CIRS)
      were calculated.
observational model: Cohort
time perspective: Prospective
measure: Blood concentrations of amoxicillin-clavulanate.
time frame: Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
description: To investigate whether blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens in first-dose or early-dose conditions and in steady-state conditions.
measure: Blood concentrations of piperacillin-tazobactam.
time frame: Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
description: To investigate whether blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens in first-dose or early-dose conditions and in steady-state conditions.
measure: Blood concentrations of temocillin.
time frame: Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
description: To investigate whether blood concentrations with maximum antimicrobial activity are achieved with current dosing regimens in first-dose or early-dose conditions and in steady-state conditions.
measure: Measured total and unbound concentrations of beta-lactam antibiotics.
time frame: Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
description: To compare measured total and unbound concentrations of beta-lactam antibiotics with predefined pharmacodynamic targets.
measure: Response to antimicrobial therapy.
time frame: The end of individual antibiotic therapy with an average of 1 week
description: To describe therapeutic response to antimicrobial therapy using procalcitonin.
measure: Achievement of pharmacodynamic targets measured by questionnaire, vital signs, blood results and side effects.
time frame: The end of individual antibiotic therapy with an average of 1 week
description: To compare achievement of pharmacodynamic targets in early-dose and steady-state conditions.
measure: Clearance of betalactam antibiotics.
time frame: Within the first 12 hours (early dose) of treatment and after 24 - 48 hours of treatment (steady state)
description: To compare clearance of betalactam antibiotics and correlate with renal function using creatinin clearance en cystatin C.
arm group label: Amoxicillin-clavulanate
description: Administration of amoxicillin-clavulanate as standard care therapy (4x or 6x 1g/d). Blood sampling in early and steady state dose (up to 5 samplings per dose). Collection of hemocultures, urine samples and sputum samples when possible.
arm group label: Piperacillin-tazobactam
description: Administration of piperacillin-tazobactam as standard care therapy (4x 4g/d). Blood sampling in early and steady state dose (up to 5 samplings per dose). Collection of hemocultures, urine samples and sputum samples when possible.
arm group label: Temocillin
description: Administration of temocillin as standard care therapy (2x or 3x 2g/d). Blood sampling in early and steady state dose (up to 5 samplings per dose). Collection of hemocultures, urine samples and sputum samples when possible.
intervention type: Diagnostic Test
intervention name: Blood sampling
description: At predefined time points through a venous catheter already in place. Max. volume to be withdrawn: Maximum 4ml/sample. Maximum 10 samples/patient.
A last blood sample will be taken, if necessary, after the end of antibiotic therapy, between day 7 and day 14. Though blood results preferably will be used from available data from tests already done during standard treatment.
Samples are collected in lithium-heparin tubes (without gel) and centrifuged immediately (within a maximum of 30 minutes after sampling) at room temperature: 8 minutes at 1885g.
Plasma is then collected and divided in two separated labelled Eppendorf tubes 1.5 ml and immediately frozen at - 80 °C. If this is not immediately possible, tubes are frozen at - 20 °C and at regular time points transferred to a freezer at - 80 °C (minimum twice a day).
arm group label: Amoxicillin-clavulanate
arm group label: Piperacillin-tazobactam
arm group label: Temocillin
intervention type: Diagnostic Test
intervention name: Sputum sample
description: Bacteriological specimen, such as blood cultures, urine samples, sputum ea., which are usually collected in every patient according to standard care will be retained. If there is bacterial growth, MIC's will be calculated on these strains for study purpose.
arm group label: Amoxicillin-clavulanate
arm group label: Piperacillin-tazobactam
arm group label: Temocillin
intervention type: Diagnostic Test
intervention name: Hemoculture
description: Bacteriological specimen, such as blood cultures, urine samples, sputum ea., which are usually collected in every patient according to standard care will be retained. If there is bacterial growth, MIC's will be calculated on these strains for study purpose.
arm group label: Amoxicillin-clavulanate
arm group label: Piperacillin-tazobactam
arm group label: Temocillin
intervention type: Diagnostic Test
intervention name: Urine sample
description: Bacteriological specimen, such as blood cultures, urine samples, sputum ea., which are usually collected in every patient according to standard care will be retained. If there is bacterial growth, MIC's will be calculated on these strains for study purpose.
arm group label: Amoxicillin-clavulanate
arm group label: Piperacillin-tazobactam
arm group label: Temocillin
Whole blood, serum, plasma, blood cultures, urine samples, sputum.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Tania Desmet, Dr.
role: Principal Investigator
affiliation: University Hospital, Ghent
last name: Peter De Paepe, Prof. Dr.
phone: 003293325211
email: peter.depaepe@uzgent.be
last name: Tania Desmet, Dr.
phone: 003293321559
email: tania.desmet@uzgent.be
facility: 
status: Recruiting
contact: 
contact backup: 
country: Belgium
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Bacterial Infections
mesh term: Emergencies
mesh term: Frailty
sharing ipd: Yes
ipd description: Students participating at the study (registered ethical committee) can consult individual participant data.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: During the whole study course.
ipd access criteria: To be approved by ethical committee.