<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/NCT02966457</url>
  </required_header>
  <id_info>
    <org_study_id>HEM-3_1</org_study_id>
    <nct_id>NCT02966457</nct_id>
  </id_info>
  <brief_title>A Study of DEcolonization in Patients With HAematological Malignancies (DEHAM)</brief_title>
  <acronym>DEHAM</acronym>
  <official_title>A Randomized Clinical Study of the Decolonization of MDR Gram-negative Bacteria in Patients With Haematological Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Belarusian State Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      MDR (multidrug resistant) gram-negative bacteria have emerged as an important cause of&#xD;
      bloodstream infection in hospitalized patients, especially in immunocompromised hosts. It was&#xD;
      previously shown, that intestinal colonization with extended-spectrum β-lactamases&#xD;
      (ESBL)-producing or carbapenem-resistant Enterobacteriaceae, carbapenem-resistant A.&#xD;
      baumannii and P. aeruginosa) is a clinical predictor of bloodstream infections in patients&#xD;
      with haematological malignancies and/or haematopoietic stem cell transplantation [Stoma I. et&#xD;
      al., 2016].&#xD;
&#xD;
      To the investigators knowledge no randomized, placebo-controlled clinical trial has been&#xD;
      performed to study the efficacy and safety of selective intestinal decolonization strategies&#xD;
      in high-risk patients with haematological malignancies. Possible decolonization of MDR&#xD;
      gram-negative bacteria in haematological patients could be important for the patient by&#xD;
      reducing the risk of infection and for the community by reducing the risk of transmission.&#xD;
&#xD;
      The purpose of the proposed study is to assess the efficacy and safety of selective&#xD;
      intestinal decolonization of MDR gram-negative bacteria with oral administration of&#xD;
      Colistimethate sodium in high risk patients with haematological malignancies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of eradication of ESBL-producing or carbapenem-resistant Enterobacteriaceae, carbapenem-resistant A. baumannii or P. aeruginosa at day 21 post-treatment</measure>
    <time_frame>21 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of resistance of isolated on day 21 post-treatment Enterobacteriaceae, A. baumannii, P. aeruginosa to polymyxin antibiotics</measure>
    <time_frame>21 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Hematological Infection</condition>
  <arm_group>
    <arm_group_label>Selective intestinal decolonization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Decolonization with Colistimethate sodium (2 mln I.U. 4x/day PO) for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&quot;Wait and watch&quot; strategy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group without decolonization interventions</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Colistimethate Sodium</intervention_name>
    <description>Selective oral intestinal decolonization</description>
    <arm_group_label>Selective intestinal decolonization</arm_group_label>
    <other_name>Colistin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Microbiologically proven rectal carriage of ESBL-producing Enterobacteriaceae or&#xD;
             carbapenem-resistant Enterobacteriaceae, A. baumannii, P. aeruginosa without signs and&#xD;
             symptoms of active infection.&#xD;
&#xD;
          2. Patient must give written informed consent to participate in the study. The informed&#xD;
             consent can be given by the legal representative if necessary.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active bacterial, viral, fungal or protozoal infection&#xD;
&#xD;
          2. Women who are pregnant or nursing&#xD;
&#xD;
          3. Antibacterial therapy in previous 10 days&#xD;
&#xD;
          4. Contraindication to the use of one of the study drugs (including known&#xD;
             hypersensitivity)&#xD;
&#xD;
          5. Patient already enrolled in another study, or in the present study for a previous&#xD;
             episode&#xD;
&#xD;
          6. Psychiatric disorder or unable to understand or to follow the protocol directions&#xD;
&#xD;
          7. Resistance of the primarily isolated colonizing microorganism to polymyxin antibiotics&#xD;
             proven by methods of polymerase chain reaction&#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>Ihar Iskrou, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Republican Center of Hematology and Bone Marrow Transplantation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Republican Center of Hematology and Bone Marrow Transplantation</name>
      <address>
        <city>Minsk</city>
        <zip>220045</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belarus</country>
  </location_countries>
  <reference>
    <citation>Stoma I, Karpov I, Milanovich N, Uss A, Iskrov I. Risk factors for mortality in patients with bloodstream infections during the pre-engraftment period after hematopoietic stem cell transplantation. Blood Res. 2016 Jun;51(2):102-6. doi: 10.5045/br.2016.51.2.102. Epub 2016 Jun 23.</citation>
    <PMID>27382554</PMID>
  </reference>
  <reference>
    <citation>Rieg S, Kupper MF, de With K, Serr A, Bohnert JA, Kern WV. Intestinal decolonization of Enterobacteriaceae producing extended-spectrum beta-lactamases (ESBL): a retrospective observational study in patients at risk for infection and a brief review of the literature. BMC Infect Dis. 2015 Oct 28;15:475. doi: 10.1186/s12879-015-1225-0.</citation>
    <PMID>26511929</PMID>
  </reference>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>December 26, 2017</last_update_submitted>
  <last_update_submitted_qc>December 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology</investigator_affiliation>
    <investigator_full_name>Ihar Iskrou</investigator_full_name>
    <investigator_title>Head of Cell Transplant Division</investigator_title>
  </responsible_party>
  <keyword>hematological infection, decolonization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colistin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 8, 2018</submitted>
    <returned>September 24, 2018</returned>
    <submitted>August 28, 2022</submitted>
    <returned>July 17, 2023</returned>
  </pending_results>
  <!-- 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/NCT02966457
org study id: HEM-3_1
nct id: NCT02966457
lead sponsor: 
collaborator: 
has dmc: Yes
MDR (multidrug resistant) gram-negative bacteria have emerged as an important cause of
      bloodstream infection in hospitalized patients, especially in immunocompromised hosts. It was
      previously shown, that intestinal colonization with extended-spectrum β-lactamases
      (ESBL)-producing or carbapenem-resistant Enterobacteriaceae, carbapenem-resistant A.
      baumannii and P. aeruginosa) is a clinical predictor of bloodstream infections in patients
      with haematological malignancies and/or haematopoietic stem cell transplantation [Stoma I. et
      al., 2016].

      To the investigators knowledge no randomized, placebo-controlled clinical trial has been
      performed to study the efficacy and safety of selective intestinal decolonization strategies
      in high-risk patients with haematological malignancies. Possible decolonization of MDR
      gram-negative bacteria in haematological patients could be important for the patient by
      reducing the risk of infection and for the community by reducing the risk of transmission.

      The purpose of the proposed study is to assess the efficacy and safety of selective
      intestinal decolonization of MDR gram-negative bacteria with oral administration of
      Colistimethate sodium in high risk patients with haematological malignancies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Rate of eradication of ESBL-producing or carbapenem-resistant Enterobacteriaceae, carbapenem-resistant A. baumannii or P. aeruginosa at day 21 post-treatment
time frame: 21 days
measure: Rate of resistance of isolated on day 21 post-treatment Enterobacteriaceae, A. baumannii, P. aeruginosa to polymyxin antibiotics
time frame: 21 days
arm group label: Selective intestinal decolonization
arm group type: Experimental
description: Drug: Decolonization with Colistimethate sodium (2 mln I.U. 4x/day PO) for 14 days
arm group label: "Wait and watch" strategy
arm group type: No Intervention
description: Group without decolonization interventions
intervention type: Drug
intervention name: Colistimethate Sodium
description: Selective oral intestinal decolonization
arm group label: Selective intestinal decolonization
other name: Colistin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ihar Iskrou, Ph.D.
role: Study Chair
affiliation: Republican Center of Hematology and Bone Marrow Transplantation
facility: 
country: Belarus
citation: Stoma I, Karpov I, Milanovich N, Uss A, Iskrov I. Risk factors for mortality in patients with bloodstream infections during the pre-engraftment period after hematopoietic stem cell transplantation. Blood Res. 2016 Jun;51(2):102-6. doi: 10.5045/br.2016.51.2.102. Epub 2016 Jun 23.
PMID: 27382554
citation: Rieg S, Kupper MF, de With K, Serr A, Bohnert JA, Kern WV. Intestinal decolonization of Enterobacteriaceae producing extended-spectrum beta-lactamases (ESBL): a retrospective observational study in patients at risk for infection and a brief review of the literature. BMC Infect Dis. 2015 Oct 28;15:475. doi: 10.1186/s12879-015-1225-0.
PMID: 26511929
responsible party type: Principal Investigator
investigator affiliation: Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
investigator full name: Ihar Iskrou
investigator title: Head of Cell Transplant Division
mesh term: Hematologic Neoplasms
mesh term: Colistin
sharing ipd: No
submitted: January 8, 2018
returned: September 24, 2018
submitted: August 28, 2022
returned: July 17, 2023