<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/NCT03825874</url>
  </required_header>
  <id_info>
    <org_study_id>MIKA</org_study_id>
    <secondary_id>2017-A02372-51</secondary_id>
    <nct_id>NCT03825874</nct_id>
  </id_info>
  <brief_title>Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children</brief_title>
  <acronym>MIKA</acronym>
  <official_title>Comparison of the Impact on Digestive Portage of Broad Spectrum Beta-Lactamase-Producing Enterobacteriaceae (E-ESBLs) of Proposed Treatments in Outbreaks of Childhood Urinary Tract Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Intercommunal Creteil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Intercommunal Creteil</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 emergence of extended-spectrum beta-lactamase-producing Enterobacteriaceae (E-ESBL) is a&#xD;
      major public health problem. It leads more frequent prescription of penems with the risk of&#xD;
      emergence and spread of strains producing carbapenemases, which may be resistant to all known&#xD;
      antibiotics. A policy of savings of penems is desirable. Among the alternatives to penems,&#xD;
      amikacin is in the foreground. It remains active on the majority of E-ESBL strains. Some risk&#xD;
      factors for E-ESBL emergence are known: recent antibiotic therapy (particularly quinolones&#xD;
      and cephalosporins third generation), previous hospitalization or residence in a high endemic&#xD;
      country.&#xD;
&#xD;
      In pediatrics, E-ESBLs are primarily responsible for urinary tract infection. In France,&#xD;
      E-ESBLs represent about 10% of the strains responsible for urinary tract infections. The&#xD;
      Pathology Group Pediatric Infectious (GPIP) of the French Society of Pediatrics (SFP) and the&#xD;
      Society of Infectious Pathology French Language (SPILF) have proposed different therapeutic&#xD;
      options to treat febrile UTIs in children: amikacin intravenous; intravenous (IV) ceftriaxone&#xD;
      or intramuscular (IM); or cefixime per-os (PO).&#xD;
&#xD;
      The objective of this study is to compare the emergence of E-ESBLs in stools of children&#xD;
      after febrile UTIs treatment with amikacin IV versus ceftriaxone or cefixime.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 18, 2019</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of E-BLSE in stools</measure>
    <time_frame>day 4</time_frame>
    <description>ano-rectal swab</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Type of E-BLSE strain in stools</measure>
    <time_frame>day 4</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of enzymatic resistance of E-BLSE strain in stools</measure>
    <time_frame>4 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fever</measure>
    <time_frame>4 days</time_frame>
    <description>Time of apyrexia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>side effects due to antibiotic therapy</measure>
    <time_frame>at 1.5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of relapse of urinary tract infection</measure>
    <time_frame>1.5 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Urinary Tract Infections</condition>
  <condition>Urinary Tract Infections in Children</condition>
  <arm_group>
    <arm_group_label>amikacin IV</arm_group_label>
    <description>Febrile urinary tract infection treated with amikacin IV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other antibiotics</arm_group_label>
    <description>Febrile urinary tract infection treated with other antibiotic, according to the recommendations: ceftriaxone or cefixime</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Amikacin</intervention_name>
    <description>A first anorectal swab will be performed before starting any antibiotic treatment Three to four days after the start of antibiotic treatment, patients will be seen again and a new anorectal swab will be performed.</description>
    <arm_group_label>amikacin IV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>usual antibiotic treatment</intervention_name>
    <description>A first anorectal swab will be performed before starting any antibiotic treatment Three to four days after the start of antibiotic treatment, patients will be seen again and a new anorectal swab will be performed.</description>
    <arm_group_label>Other antibiotics</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      anorectal swab&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Child from 3 months to 3 years treated for febrile urinary tract infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infant and child (age ≥ 3 months and &lt;3 years)&#xD;
&#xD;
          -  Patient treated for febrile urinary tract infection as monotherapy with amikacin IV,&#xD;
             ceftriaxone (IV or IM) or cefixime PO *&#xD;
&#xD;
          -  Whose parents read and understood the newsletter and whose express consent was&#xD;
             collected&#xD;
&#xD;
          -  Patient affiliated to a social security scheme (Social Security or Universal Medical&#xD;
             Coverage)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child treated with more than one antibiotic (eg treatment with dual therapy&#xD;
             ceftriaxone / cefotaxime and aminoglycoside)&#xD;
&#xD;
          -  Antibiotherapy in progress or discontinued in the previous 7 days&#xD;
&#xD;
          -  Hospitalized child&#xD;
&#xD;
          -  Refusal of one of the parents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>3 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Fouad MADHI, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHI Créteil</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fouad Madhi, MD</last_name>
    <phone>+33157025422</phone>
    <email>fouad.madhi@chicreteil.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Antoine Beclère Hospital</name>
      <address>
        <city>Clamart</city>
        <state>Ile-de France</state>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Vincent Gadjos</last_name>
      <email>vincent.gajdos@abc.aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jean Verdier Hospital</name>
      <address>
        <city>Bondy</city>
        <state>Ile-de-France</state>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aurélien Galerne</last_name>
      <email>aurelien.galerne@aphp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>André Mignot Hospital</name>
      <address>
        <city>Le Chesnay</city>
        <state>Ile-de-France</state>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Marie-Aliette Dommergues</last_name>
      <email>madommergues@ch-versailles.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cabinet du Dr Benali</name>
      <address>
        <city>Charenton-le-Pont</city>
        <zip>94220</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hadj Benali</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cabinet du Dr Coicadan</name>
      <address>
        <city>Chennevières-sur-Marne</city>
        <zip>94430</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucette Coicadan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cabinet du Dr Corrard</name>
      <address>
        <city>Combs-la-Ville</city>
        <zip>77380</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>François Corrard</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cabinet du Dr Thollot</name>
      <address>
        <city>Essey-lès-Nancy</city>
        <zip>54270</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Franck Thollot</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Le Kremlin-Bicêtre</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Irina Craiu</last_name>
      <email>craiu@voila.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>157 Avenue du Général Leclerc</name>
      <address>
        <city>Maisons-Alfort</city>
        <zip>94700</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Annie ELBEZ</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Meaux</name>
      <address>
        <city>Meaux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Olivier Vignaud</last_name>
      <email>o-vignaud@ch-meaux.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cabinet du Dr Deberdt</name>
      <address>
        <city>Nogent-sur-Marne</city>
        <zip>94130</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrice Deberdt</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cabinet du Dr Wollner</name>
      <address>
        <city>Nogent-sur-Marne</city>
        <zip>94130</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alain Wollner</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cabinet du Dr Romain</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier Romain</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cabinet du Dr Turberg-Romain</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine Turberg-Romain</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cabinet du Dr Michot</name>
      <address>
        <city>Paris</city>
        <zip>75016</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne-Sylvestre Michot</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Robert-Debré</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexis Rybak</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cabinet du Dr Cohen</name>
      <address>
        <city>Saint-Maur-des-Fossés</city>
        <zip>94100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Cohen</last_name>
    </contact>
    <investigator>
      <last_name>Mohammed Benani</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nadia D'Ovidio</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marc Koskas</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aurélie SELLAM</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cabinet du Dr Werner</name>
      <address>
        <city>Villeneuve-lès-Avignon</city>
        <zip>30400</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreas Werner</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHI Villeneuve-Saint-Georges</name>
      <address>
        <city>Villeneuve-Saint-Georges</city>
        <zip>94195</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aurélie GARRAFFO</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>13 Villa Beauséjour</name>
      <address>
        <city>Vincennes</city>
        <zip>94300</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Christophe BATARD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 8, 2018</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 25, 2023</last_update_submitted>
  <last_update_submitted_qc>January 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Urinary Tract Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Amikacin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03825874
org study id: MIKA
secondary id: 2017-A02372-51
nct id: NCT03825874
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The emergence of extended-spectrum beta-lactamase-producing Enterobacteriaceae (E-ESBL) is a
      major public health problem. It leads more frequent prescription of penems with the risk of
      emergence and spread of strains producing carbapenemases, which may be resistant to all known
      antibiotics. A policy of savings of penems is desirable. Among the alternatives to penems,
      amikacin is in the foreground. It remains active on the majority of E-ESBL strains. Some risk
      factors for E-ESBL emergence are known: recent antibiotic therapy (particularly quinolones
      and cephalosporins third generation), previous hospitalization or residence in a high endemic
      country.

      In pediatrics, E-ESBLs are primarily responsible for urinary tract infection. In France,
      E-ESBLs represent about 10% of the strains responsible for urinary tract infections. The
      Pathology Group Pediatric Infectious (GPIP) of the French Society of Pediatrics (SFP) and the
      Society of Infectious Pathology French Language (SPILF) have proposed different therapeutic
      options to treat febrile UTIs in children: amikacin intravenous; intravenous (IV) ceftriaxone
      or intramuscular (IM); or cefixime per-os (PO).

      The objective of this study is to compare the emergence of E-ESBLs in stools of children
      after febrile UTIs treatment with amikacin IV versus ceftriaxone or cefixime.
observational model: Other
time perspective: Prospective
measure: Presence of E-BLSE in stools
time frame: day 4
description: ano-rectal swab
measure: Type of E-BLSE strain in stools
time frame: day 4
measure: Rate of enzymatic resistance of E-BLSE strain in stools
time frame: 4 days
measure: Fever
time frame: 4 days
description: Time of apyrexia
measure: side effects due to antibiotic therapy
time frame: at 1.5 months
measure: rate of relapse of urinary tract infection
time frame: 1.5 months
arm group label: amikacin IV
description: Febrile urinary tract infection treated with amikacin IV
arm group label: Other antibiotics
description: Febrile urinary tract infection treated with other antibiotic, according to the recommendations: ceftriaxone or cefixime
intervention type: Other
intervention name: Amikacin
description: A first anorectal swab will be performed before starting any antibiotic treatment Three to four days after the start of antibiotic treatment, patients will be seen again and a new anorectal swab will be performed.
arm group label: amikacin IV
intervention type: Other
intervention name: usual antibiotic treatment
description: A first anorectal swab will be performed before starting any antibiotic treatment Three to four days after the start of antibiotic treatment, patients will be seen again and a new anorectal swab will be performed.
arm group label: Other antibiotics
anorectal swab
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Months
maximum age: 3 Years
last name: Fouad MADHI, MD
role: Principal Investigator
affiliation: CHI Créteil
last name: Fouad Madhi, MD
phone: +33157025422
email: fouad.madhi@chicreteil.fr
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Urinary Tract Infections
mesh term: Anti-Bacterial Agents
mesh term: Amikacin
sharing ipd: No