<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/NCT03231267</url>
  </required_header>
  <id_info>
    <org_study_id>NI16011</org_study_id>
    <secondary_id>ID RCB 2016-A01787-44</secondary_id>
    <nct_id>NCT03231267</nct_id>
  </id_info>
  <brief_title>Existence in the Human Digestive Flora of Phages Able to Prevent the Acquisition of Multiresistant Enterobacteria</brief_title>
  <acronym>PHAGO-BMR</acronym>
  <official_title>Existence in the Human Digestive Flora of Phages Able to Prevent the Acquisition of Multiresistant Enterobacteria: PHAGO- BMR</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      This research focuses on antibiotic resistant bacteria that may reside in the digestive tract&#xD;
      (intestinal flora) of everyone.&#xD;
&#xD;
      When we develop an infection, the bacteria in question is, often, already present in our&#xD;
      flora. Face to the growing phenomenon of multi-resistance, which is a public health problem,&#xD;
      it is essential to follow the frequency of these bacteria but also to find new strategies and&#xD;
      effective means to fight against their spread.&#xD;
&#xD;
      It has been discovered long time ago that it exists viruses able of destroying bacteria: they&#xD;
      have been called bacteriophages .They was used before the arrival of antibiotics for the&#xD;
      treatment of various infections (phagotherapy). Today, with the problems of resistance,&#xD;
      phagotherapy could become a good way to fight against infections with bacteria very resistant&#xD;
      but also a way to remove the resistant bacteria that are present in our digestive flora.&#xD;
&#xD;
      Moreover, it is known that these viruses of bacteria are present everywhere in the&#xD;
      environment (waters, soils, human digestive tract and animal), it is important to check their&#xD;
      presence in our digestive tract. Our objective is to study if the presence of these phages&#xD;
      prevents resistant bacteria from set up in our digestive flora.&#xD;
&#xD;
      To answer the question, it is planned to include 460 people hospitalized in intensive care&#xD;
      unit (resuscitation). The choice of this unit is linked to the fact that the monitoring of&#xD;
      resistant bacteria is carried out regularly during the hospitalization. Three resuscitation&#xD;
      services were recruited: 2 in Saint Antoine Hospital and 1 in Tenon Hospital. On stool&#xD;
      samples collected at different times of the stay (admission and then during the stay), we&#xD;
      will look for 2 types of bacteria and viruses capable of destroying them.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluate the association between the presence of phage (s) in patients not carrying E. coli&#xD;
      or K. pneumoniae ESBL or carbapenemase (EPC) (Ec-ESBL / EPC or Kp-ESBL / EPC) and subsequent&#xD;
      acquisition Of carrying Ec-BLSE / EPC or Kp-BLSE / EPC during their stay in intensive care.&#xD;
&#xD;
      Collection of stools of the patients included at the admission then in a successive way. On&#xD;
      the first stool, search for multiresistant bacteria. If positive research: search for&#xD;
      bacteriophage directed against the strain of the patient bearing. Continued screening of&#xD;
      stools from non-carriers at baseline.&#xD;
&#xD;
      In patients defined as non-carriers at the end of the inclusions and collection, selection of&#xD;
      8 stools for the detection of bacteriophages directed against all BMR strains which were&#xD;
      isolated during the study period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 12, 2018</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">February 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence or absence of phages capable of lysing circulating Ec-ESBL / EPC or Kp-ESBE / EPC in resuscitation units in non-carriers having acquired carriers E. coli or K. pneumoniae producing ESBL or carbapenemases .</measure>
    <time_frame>Through study completion. An average of 1 year after the study completion.</time_frame>
    <description>The classification of patients in the Carrier / Non-carrier group is based on analysis of 2 consecutive faecal samples: at least one positive sample is required to consider the patient as &quot;carrier&quot; of Ec-ESBL / EPC or Kp-ESBL / EPC ; It necessary to have at least 2 negative excrement to consider the patient &quot;non-carrier. &quot; The rate of acquisition of Ec-ESBL / EPC or Kp-ESBL / EPC will be evaluated in non-carrier patients monitored during the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence or absence of phages in patients identified as carriers of Ec-ESBL / EPC or Kp-ESBL / EPC at entry to resuscitation (control population).</measure>
    <time_frame>Through study completion. An average of 1 year after the study completion.</time_frame>
    <description>Characterization of isolated phages: number and specificity (lysis capacity of one or more strains of Ec-ESBL / EPC or Kp-ESBL / EPC evaluated by the percentage of patients carrying the Ec-ESBL / EPC or Kp-ESBL / EPC ).</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">460</enrollment>
  <condition>Multiresistant Enterobacteriaceae</condition>
  <arm_group>
    <arm_group_label>&quot;Carrier&quot;of Ec-BLSE/EPC or Kp-BLSE/EPC</arm_group_label>
    <description>During resuscitation, evaluation of the acquisition or not of phages able to lyse Ec-BLSE / EPC or Kp-BLSE / EPC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Carrier of Ec-BLSE/EPC orKp-BLSE/EPC</arm_group_label>
    <description>During resuscitation, evaluation of the acquisition or not of phages able to lyse Ec-BLSE / EPC or Kp-BLSE / EPC</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients : adults admitted in intensive care for a period &gt; 72h&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  Admission in reanimation&#xD;
&#xD;
          -  Duration of stay &gt; 72 h.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of at least 2 consecutive faeces.&#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>Dominique DECRE, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>réanimation médicale Hôpital Saint Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Adhya S, Merril CR, Biswas B. Therapeutic and prophylactic applications of bacteriophage components in modern medicine. Cold Spring Harb Perspect Med. 2014 Jan 1;4(1):a012518. doi: 10.1101/cshperspect.a012518.</citation>
    <PMID>24384811</PMID>
  </reference>
  <reference>
    <citation>Balcazar JL. Bacteriophages as vehicles for antibiotic resistance genes in the environment. PLoS Pathog. 2014 Jul 31;10(7):e1004219. doi: 10.1371/journal.ppat.1004219. eCollection 2014 Jul. No abstract available.</citation>
    <PMID>25078987</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>May 2, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 15, 2019</last_update_submitted>
  <last_update_submitted_qc>July 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiresistant enterobacteriaceae</keyword>
  <keyword>digestive colonization</keyword>
  <keyword>bacteriophages</keyword>
  <keyword>Admission in intensive care unit &gt;72h</keyword>
  <keyword>Presence of at least 2 consecutive stools</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03231267
org study id: NI16011
secondary id: ID RCB 2016-A01787-44
nct id: NCT03231267
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research focuses on antibiotic resistant bacteria that may reside in the digestive tract
      (intestinal flora) of everyone.

      When we develop an infection, the bacteria in question is, often, already present in our
      flora. Face to the growing phenomenon of multi-resistance, which is a public health problem,
      it is essential to follow the frequency of these bacteria but also to find new strategies and
      effective means to fight against their spread.

      It has been discovered long time ago that it exists viruses able of destroying bacteria: they
      have been called bacteriophages .They was used before the arrival of antibiotics for the
      treatment of various infections (phagotherapy). Today, with the problems of resistance,
      phagotherapy could become a good way to fight against infections with bacteria very resistant
      but also a way to remove the resistant bacteria that are present in our digestive flora.

      Moreover, it is known that these viruses of bacteria are present everywhere in the
      environment (waters, soils, human digestive tract and animal), it is important to check their
      presence in our digestive tract. Our objective is to study if the presence of these phages
      prevents resistant bacteria from set up in our digestive flora.

      To answer the question, it is planned to include 460 people hospitalized in intensive care
      unit (resuscitation). The choice of this unit is linked to the fact that the monitoring of
      resistant bacteria is carried out regularly during the hospitalization. Three resuscitation
      services were recruited: 2 in Saint Antoine Hospital and 1 in Tenon Hospital. On stool
      samples collected at different times of the stay (admission and then during the stay), we
      will look for 2 types of bacteria and viruses capable of destroying them.
Evaluate the association between the presence of phage (s) in patients not carrying E. coli
      or K. pneumoniae ESBL or carbapenemase (EPC) (Ec-ESBL / EPC or Kp-ESBL / EPC) and subsequent
      acquisition Of carrying Ec-BLSE / EPC or Kp-BLSE / EPC during their stay in intensive care.

      Collection of stools of the patients included at the admission then in a successive way. On
      the first stool, search for multiresistant bacteria. If positive research: search for
      bacteriophage directed against the strain of the patient bearing. Continued screening of
      stools from non-carriers at baseline.

      In patients defined as non-carriers at the end of the inclusions and collection, selection of
      8 stools for the detection of bacteriophages directed against all BMR strains which were
      isolated during the study period.
observational model: Case-Control
time perspective: Prospective
measure: Presence or absence of phages capable of lysing circulating Ec-ESBL / EPC or Kp-ESBE / EPC in resuscitation units in non-carriers having acquired carriers E. coli or K. pneumoniae producing ESBL or carbapenemases .
time frame: Through study completion. An average of 1 year after the study completion.
description: The classification of patients in the Carrier / Non-carrier group is based on analysis of 2 consecutive faecal samples: at least one positive sample is required to consider the patient as "carrier" of Ec-ESBL / EPC or Kp-ESBL / EPC ; It necessary to have at least 2 negative excrement to consider the patient "non-carrier. " The rate of acquisition of Ec-ESBL / EPC or Kp-ESBL / EPC will be evaluated in non-carrier patients monitored during the study.
measure: Presence or absence of phages in patients identified as carriers of Ec-ESBL / EPC or Kp-ESBL / EPC at entry to resuscitation (control population).
time frame: Through study completion. An average of 1 year after the study completion.
description: Characterization of isolated phages: number and specificity (lysis capacity of one or more strains of Ec-ESBL / EPC or Kp-ESBL / EPC evaluated by the percentage of patients carrying the Ec-ESBL / EPC or Kp-ESBL / EPC ).
arm group label: "Carrier"of Ec-BLSE/EPC or Kp-BLSE/EPC
description: During resuscitation, evaluation of the acquisition or not of phages able to lyse Ec-BLSE / EPC or Kp-BLSE / EPC
arm group label: Non-Carrier of Ec-BLSE/EPC orKp-BLSE/EPC
description: During resuscitation, evaluation of the acquisition or not of phages able to lyse Ec-BLSE / EPC or Kp-BLSE / EPC
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dominique DECRE, Doctor
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
citation: Adhya S, Merril CR, Biswas B. Therapeutic and prophylactic applications of bacteriophage components in modern medicine. Cold Spring Harb Perspect Med. 2014 Jan 1;4(1):a012518. doi: 10.1101/cshperspect.a012518.
PMID: 24384811
citation: Balcazar JL. Bacteriophages as vehicles for antibiotic resistance genes in the environment. PLoS Pathog. 2014 Jul 31;10(7):e1004219. doi: 10.1371/journal.ppat.1004219. eCollection 2014 Jul. No abstract available.
PMID: 25078987
responsible party type: Sponsor
sharing ipd: Undecided