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/NCT05983861</url>
    </required_header>
    <id_info>
      <org_study_id>17/2023</org_study_id>
      <nct_id>NCT05983861</nct_id>
    </id_info>
    <brief_title>Risk Factors for Multidrug Resistant Bacteria at ICU Admission</brief_title>
    <official_title>Risk Factors for Multidrug Resistant Bacteria at ICU Admission</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>José Raimundo Araujo de Azevedo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospital Sao Domingos</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>
        The objective of this single-center prospective observational study is to evaluate possible&#xD;
        independent risk factors for multidrug-resistant (MDR) bacteria upon ICU admission by&#xD;
        analyzing comorbidities, epidemiological data, and laboratory/microbiological information of&#xD;
        the subjects.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: Infection is one of the main reason for a patient to be admitted to an intensive&#xD;
        care unit (ICU) and it's fundamental to use the right antibiotic as soon as possible,&#xD;
        possibly needing broad-spectrum antibiotics. However, the main problem is that widening the&#xD;
        spectrum of drugs will generate pressure on the hospital microbiota, leading to the&#xD;
        development of multi-drug resistant bacteria&#xD;
  &#xD;
        Purpose: A large number of ICU-admitted patients have infection/sepsis as their major&#xD;
        problem, requiring treatment with antibiotics. With knowledge of the presumed risk factors&#xD;
        for antibiotic resistance, the assistant physician could use broad-spectrum drugs with&#xD;
        greater certainty.&#xD;
  &#xD;
        Objectives: Our objective will be to evaluate risk factors for infection caused by multi-drug&#xD;
        resistant germs upon ICU admission and assess the severity of the disease in comparison to&#xD;
        patients infected with susceptible bacteria. Ultimately, we aim to develop and validate a&#xD;
        clinical tool to assist physicians in selecting the appropriate antibiotic for their patients&#xD;
  &#xD;
        Methods: An observational prospective study with a control group will be conducted, including&#xD;
        all patients admitted to the ICU with an infectious disease initiated within 48 hours of&#xD;
        hospital admission and with a positive microbiologic result. Patients with isolation of only&#xD;
        susceptible bacteria will be allocated to the control group, while patients with MDR bacteria&#xD;
        will be assigned to the study group, referred to as the MDR group. The data to be collected&#xD;
        will include sex, age, previous use of antibiotics in the last three months, previous&#xD;
        hospital admissions, previous isolation of MDR germs, sensitivity profile of the isolated&#xD;
        germs, severity of disease (measured by SAPS 3), presence of sepsis diagnosis at admission,&#xD;
        length of stay in the ICU, and 28-day mortality&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 31, 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>Determine risk factors for multi-drug resistant germs in ICU admission.</measure>
      <time_frame>28 days</time_frame>
      <description>Analysis of resistance profile of germs and patient's comorbidities to determine the risk factors for drug resistance.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mortality between control and case group</measure>
      <time_frame>28 days</time_frame>
      <description>Compare mortality in 28 days between patients with infection caused by MDR bacteria and non-resistant bacteria.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean LOS of each group</measure>
      <time_frame>28 days</time_frame>
      <description>Compare the length of stay in ICU between the control and case groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Severity between groups using SAPS 3</measure>
      <time_frame>28 days</time_frame>
      <description>Compare the severity of disease between groups using the SAPS 3 score.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Multi Drug Resistant Bacteria</condition>
    <arm_group>
      <arm_group_label>Multi drug resistant group</arm_group_label>
      <description>All critically ill adult patients (with no exclusion criteria) admitted to the ICU with microbiological confirmed diagnosis of infection at admission and multi drug resistant bacteria isolation :</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Multi sensible bacteria group</arm_group_label>
      <description>All critically ill adult patients (with no exclusion criteria) admitted to the ICU with microbiological confirmed diagnosis of infection at admission and multi drug sensible bacteria isolation :</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Identification o Multi Drug Resistant Bacteria</intervention_name>
      <description>Identification o Multi Drug Resistant Bacteria</description>
      <arm_group_label>Multi drug resistant group</arm_group_label>
      <arm_group_label>Multi sensible bacteria group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients admitted to the ICU with an infectious disease initiated within 48 hours of&#xD;
          hospital admission and with a positive microbiologic result.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients admitted to the ICU with an infectious disease initiated within 48 hours&#xD;
               of hospital admission and a microbiological positive result for bacteria&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with results considered as contamination according to the institutional&#xD;
               protocol.&#xD;
  &#xD;
            -  Surgical wound and bloodstream infections.&#xD;
  &#xD;
            -  Microbiological isolation of only fungi.&#xD;
  &#xD;
            -  Vigilance cultures, such as anal, rectal, nasal, and axillary swabs.&#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>PAULO BEZERRA, MD</last_name>
      <phone>+55 98988748865</phone>
      <email>drpaulobezerra@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>PEDRO FROTA, MD</last_name>
      <phone>+55 98999769456</phone>
      <email>pedrohfrota@gmail.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Niederman MS, Baron RM, Bouadma L, Calandra T, Daneman N, DeWaele J, Kollef MH, Lipman J, Nair GB. Initial antimicrobial management of sepsis. Crit Care. 2021 Aug 26;25(1):307. doi: 10.1186/s13054-021-03736-w.</citation>
      <PMID>34446092</PMID>
    </reference>
    <results_reference>
      <citation>Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Moller M, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143. doi: 10.1097/CCM.0000000000005337. No abstract available.</citation>
      <PMID>34605781</PMID>
    </results_reference>
    <results_reference>
      <citation>Bassetti M, Rello J, Blasi F, Goossens H, Sotgiu G, Tavoschi L, Zasowski EJ, Arber MR, McCool R, Patterson JV, Longshaw CM, Lopes S, Manissero D, Nguyen ST, Tone K, Aliberti S. Systematic review of the impact of appropriate versus inappropriate initial antibiotic therapy on outcomes of patients with severe bacterial infections. Int J Antimicrob Agents. 2020 Dec;56(6):106184. doi: 10.1016/j.ijantimicag.2020.106184. Epub 2020 Oct 9.</citation>
      <PMID>33045353</PMID>
    </results_reference>
    <results_reference>
      <citation>Kalil AC, Johnson DW, Lisco SJ, Sun J. Early Goal-Directed Therapy for Sepsis: A Novel Solution for Discordant Survival Outcomes in Clinical Trials. Crit Care Med. 2017 Apr;45(4):607-614. doi: 10.1097/CCM.0000000000002235.</citation>
      <PMID>28067711</PMID>
    </results_reference>
    <results_reference>
      <citation>Liu VX, Fielding-Singh V, Greene JD, Baker JM, Iwashyna TJ, Bhattacharya J, Escobar GJ. The Timing of Early Antibiotics and Hospital Mortality in Sepsis. Am J Respir Crit Care Med. 2017 Oct 1;196(7):856-863. doi: 10.1164/rccm.201609-1848OC.</citation>
      <PMID>28345952</PMID>
    </results_reference>
    <results_reference>
      <citation>Wong D, Wong T, Romney M, Leung V. Comparative effectiveness of beta-lactam versus vancomycin empiric therapy in patients with methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia. Ann Clin Microbiol Antimicrob. 2016 Apr 26;15:27. doi: 10.1186/s12941-016-0143-3.</citation>
      <PMID>27112143</PMID>
    </results_reference>
    <results_reference>
      <citation>Fernandez-Martinez NF, Carcel-Fernandez S, De la Fuente-Martos C, Ruiz-Montero R, Guzman-Herrador BR, Leon-Lopez R, Gomez FJ, Guzman-Puche J, Martinez-Martinez L, Salcedo-Leal I. Risk Factors for Multidrug-Resistant Gram-Negative Bacteria Carriage upon Admission to the Intensive Care Unit. Int J Environ Res Public Health. 2022 Jan 18;19(3):1039. doi: 10.3390/ijerph19031039.</citation>
      <PMID>35162062</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Hospital Sao Domingos</investigator_affiliation>
      <investigator_full_name>José Raimundo Araujo de Azevedo</investigator_full_name>
      <investigator_title>ICU Assistent Physician</investigator_title>
    </responsible_party>
    <keyword>Infection</keyword>
    <keyword>Multi drug Resistant bacteria</keyword>
    <keyword>Risk Factors</keyword>
    <keyword>Critical Care</keyword>
    <keyword>Score</keyword>
    <patient_data>
      <sharing_ipd>No</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/NCT05983861
  org study id: 17/2023
  nct id: NCT05983861
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this single-center prospective observational study is to evaluate possible
        independent risk factors for multidrug-resistant (MDR) bacteria upon ICU admission by
        analyzing comorbidities, epidemiological data, and laboratory/microbiological information of
        the subjects.
  Background: Infection is one of the main reason for a patient to be admitted to an intensive
        care unit (ICU) and it's fundamental to use the right antibiotic as soon as possible,
        possibly needing broad-spectrum antibiotics. However, the main problem is that widening the
        spectrum of drugs will generate pressure on the hospital microbiota, leading to the
        development of multi-drug resistant bacteria
  
        Purpose: A large number of ICU-admitted patients have infection/sepsis as their major
        problem, requiring treatment with antibiotics. With knowledge of the presumed risk factors
        for antibiotic resistance, the assistant physician could use broad-spectrum drugs with
        greater certainty.
  
        Objectives: Our objective will be to evaluate risk factors for infection caused by multi-drug
        resistant germs upon ICU admission and assess the severity of the disease in comparison to
        patients infected with susceptible bacteria. Ultimately, we aim to develop and validate a
        clinical tool to assist physicians in selecting the appropriate antibiotic for their patients
  
        Methods: An observational prospective study with a control group will be conducted, including
        all patients admitted to the ICU with an infectious disease initiated within 48 hours of
        hospital admission and with a positive microbiologic result. Patients with isolation of only
        susceptible bacteria will be allocated to the control group, while patients with MDR bacteria
        will be assigned to the study group, referred to as the MDR group. The data to be collected
        will include sex, age, previous use of antibiotics in the last three months, previous
        hospital admissions, previous isolation of MDR germs, sensitivity profile of the isolated
        germs, severity of disease (measured by SAPS 3), presence of sepsis diagnosis at admission,
        length of stay in the ICU, and 28-day mortality
  observational model: Cohort
  time perspective: Prospective
  measure: Determine risk factors for multi-drug resistant germs in ICU admission.
  time frame: 28 days
  description: Analysis of resistance profile of germs and patient's comorbidities to determine the risk factors for drug resistance.
  measure: Mortality between control and case group
  time frame: 28 days
  description: Compare mortality in 28 days between patients with infection caused by MDR bacteria and non-resistant bacteria.
  measure: Mean LOS of each group
  time frame: 28 days
  description: Compare the length of stay in ICU between the control and case groups.
  measure: Severity between groups using SAPS 3
  time frame: 28 days
  description: Compare the severity of disease between groups using the SAPS 3 score.
  arm group label: Multi drug resistant group
  description: All critically ill adult patients (with no exclusion criteria) admitted to the ICU with microbiological confirmed diagnosis of infection at admission and multi drug resistant bacteria isolation :
  arm group label: Multi sensible bacteria group
  description: All critically ill adult patients (with no exclusion criteria) admitted to the ICU with microbiological confirmed diagnosis of infection at admission and multi drug sensible bacteria isolation :
  intervention type: Diagnostic Test
  intervention name: Identification o Multi Drug Resistant Bacteria
  description: Identification o Multi Drug Resistant Bacteria
  arm group label: Multi drug resistant group
  arm group label: Multi sensible bacteria group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: PAULO BEZERRA, MD
  phone: +55 98988748865
  email: drpaulobezerra@gmail.com
  last name: PEDRO FROTA, MD
  phone: +55 98999769456
  email: pedrohfrota@gmail.com
  citation: Niederman MS, Baron RM, Bouadma L, Calandra T, Daneman N, DeWaele J, Kollef MH, Lipman J, Nair GB. Initial antimicrobial management of sepsis. Crit Care. 2021 Aug 26;25(1):307. doi: 10.1186/s13054-021-03736-w.
  PMID: 34446092
  citation: Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Moller M, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143. doi: 10.1097/CCM.0000000000005337. No abstract available.
  PMID: 34605781
  citation: Bassetti M, Rello J, Blasi F, Goossens H, Sotgiu G, Tavoschi L, Zasowski EJ, Arber MR, McCool R, Patterson JV, Longshaw CM, Lopes S, Manissero D, Nguyen ST, Tone K, Aliberti S. Systematic review of the impact of appropriate versus inappropriate initial antibiotic therapy on outcomes of patients with severe bacterial infections. Int J Antimicrob Agents. 2020 Dec;56(6):106184. doi: 10.1016/j.ijantimicag.2020.106184. Epub 2020 Oct 9.
  PMID: 33045353
  citation: Kalil AC, Johnson DW, Lisco SJ, Sun J. Early Goal-Directed Therapy for Sepsis: A Novel Solution for Discordant Survival Outcomes in Clinical Trials. Crit Care Med. 2017 Apr;45(4):607-614. doi: 10.1097/CCM.0000000000002235.
  PMID: 28067711
  citation: Liu VX, Fielding-Singh V, Greene JD, Baker JM, Iwashyna TJ, Bhattacharya J, Escobar GJ. The Timing of Early Antibiotics and Hospital Mortality in Sepsis. Am J Respir Crit Care Med. 2017 Oct 1;196(7):856-863. doi: 10.1164/rccm.201609-1848OC.
  PMID: 28345952
  citation: Wong D, Wong T, Romney M, Leung V. Comparative effectiveness of beta-lactam versus vancomycin empiric therapy in patients with methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia. Ann Clin Microbiol Antimicrob. 2016 Apr 26;15:27. doi: 10.1186/s12941-016-0143-3.
  PMID: 27112143
  citation: Fernandez-Martinez NF, Carcel-Fernandez S, De la Fuente-Martos C, Ruiz-Montero R, Guzman-Herrador BR, Leon-Lopez R, Gomez FJ, Guzman-Puche J, Martinez-Martinez L, Salcedo-Leal I. Risk Factors for Multidrug-Resistant Gram-Negative Bacteria Carriage upon Admission to the Intensive Care Unit. Int J Environ Res Public Health. 2022 Jan 18;19(3):1039. doi: 10.3390/ijerph19031039.
  PMID: 35162062
  responsible party type: Sponsor-Investigator
  investigator affiliation: Hospital Sao Domingos
  investigator full name: José Raimundo Araujo de Azevedo
  investigator title: ICU Assistent Physician
  sharing ipd: No