<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/NCT03269604</url>
  </required_header>
  <id_info>
    <org_study_id>1075237598</org_study_id>
    <nct_id>NCT03269604</nct_id>
  </id_info>
  <brief_title>Effectiveness of Three Times of Starting Antibiotic Prophylaxis in Patients With Asymptomatic Bacteriuria.</brief_title>
  <official_title>Effectiveness of Three Different Times of Starting Antibiotic Prophylaxis in Patients With Asymptomatic Bacteriuria Scheduled for Urological Surgery. A Randomized Multicentric Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jorge Andres Ramos Castaneda</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CES University</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>
      Asymptomatic bacteriuria (AB) is the isolation of a bacterium in a sample of urine&#xD;
      appropriately collected from a person who does not have signs or symptoms of urinary&#xD;
      infection. It is common in diabetic women, in pregnant women, in men over 60 years and in&#xD;
      patients with spinal cord injury.&#xD;
&#xD;
      There is clinical evidence that AB should be treated in patients who will be operated on with&#xD;
      urologic surgery because of the risk of presenting infectious complications; however, the&#xD;
      timing of initiating antibiotic therapy has not been established, even in some studies the&#xD;
      prophylaxis has been considered from one to seven days prior to the procedure, without&#xD;
      determining the differences in the outcome for each one of the interventions and causing an&#xD;
      undue and risky use of antibiotics.&#xD;
&#xD;
      A randomized, parallel-design, single-masked clinical trial will be performed to compare and&#xD;
      analysis the bloodstream infections, surgical site infections, readmissions and hospital stay&#xD;
      in three intervention groups, 1) those receiving antibiotics during the previous 5 days to&#xD;
      the procedure; 2) 3 days prior to the procedure; and 3) those who receive only a single dose&#xD;
      of antibiotic on the day of the procedure.&#xD;
&#xD;
      The main expected result is to identify the timing of initiation of antibiotic prophylaxis in&#xD;
      urological procedures in patients with asymptomatic bacteriuria, with the purpose of&#xD;
      diminishing the bloodstream and of the surgical site infections. If it is scientifically&#xD;
      demonstrated that those patients who receive a single dose of antibiotic on the same day of&#xD;
      the procedure, have the same safety and effectiveness compared to the other two groups, would&#xD;
      reduce hospital stay, surgical waiting time and indiscriminate use of antibiotics that&#xD;
      generate multidrug-resistant microorganisms, thus generating an impact on Public Health and&#xD;
      on the quality of care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 22, 2018</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2018</primary_completion_date>
  <phase>N/A</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>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>A single blinding will be performed. To the database will be categorized the variable &quot;duration of prophylaxis&quot; so that the person in charge of analysing the data, does not know the true allocation of each of the participants. At the end of the tabulation and analysis of the data, the true allocation will be known.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Bloodstream infection</measure>
    <time_frame>30 days</time_frame>
    <description>An infectious process characterized by the presence of some bacteria in the bloodstream. The patient should have one or more positive blood cultures, where the cultured organism is not related to an infection elsewhere, and has signs of infection, such as fever, hypotension or tachycardia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgical Site Infection:</measure>
    <time_frame>30 days</time_frame>
    <description>It can occur up to 30 days (or a year when a prosthetic component is involved) of a surgical procedure in some part of the body where it was manipulated in surgery. The SSI is classified as superficial, deep or organ space, depending on the type of tissue involved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>30 days</time_frame>
    <description>Difference in days between the date of discharge and of the surgical procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-entry to hospitalization</measure>
    <time_frame>30 days</time_frame>
    <description>Re hospitalization after the surgical procedure due to SSI or bloodstream.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">456</enrollment>
  <condition>Asymptomatic Bacteriuria</condition>
  <condition>Antibiotic Prophylaxis</condition>
  <arm_group>
    <arm_group_label>Prophylactic antibiotic five days previous to the procedure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Prophylactic antibiotic during five days previous to the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prophylactic antibiotic three days previous to the procedure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Prophylactic antibiotic during three days previous to the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Only a single dose of Prophylactic antibiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Only a single dose of Prophylactic antibiotic on the day of the procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Prophylactic antibiotic during five days previous to the procedure</intervention_name>
    <description>Prophylactic antibiotic during five days previous to the procedure.</description>
    <arm_group_label>Prophylactic antibiotic five days previous to the procedure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Prophylactic antibiotic during three days previous to the procedure</intervention_name>
    <description>Prophylactic antibiotic during three days previous to the procedure.</description>
    <arm_group_label>Prophylactic antibiotic three days previous to the procedure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Only a single dose of Prophylactic antibiotic</intervention_name>
    <description>This group will receive a single dose of antibiotic 90 ± 20 minutes prior to the start of the surgical procedure (incision)</description>
    <arm_group_label>Only a single dose of Prophylactic antibiotic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Patients with asymptomatic bacteriuria identified with a urine culture prior to the&#xD;
             surgical procedure and with a microorganism that meets the following criteria: 1)&#xD;
             gram-negative bacteria in the enterobacterial family and non-fermenting bacilli; 2)&#xD;
             Bacteria with resistance profile has a therapeutic option that reaches therapeutic&#xD;
             concentration in urine.&#xD;
&#xD;
          -  Patients scheduled for urological procedures, such as: transurethral resection of the&#xD;
             prostate, open prostatectomy, cystoscopy, extracorporeal lithotripsy and flexible&#xD;
             ureterorenoscopy.&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with chronic renal failure; with immunosuppressive status secondary to&#xD;
             glucocorticoid consumption, haematological or solid organ neoplasms undergoing&#xD;
             chemotherapy or radiation therapy or neutropenia.&#xD;
&#xD;
          -  Patients with active infection or clinical criteria of urinary infection.&#xD;
&#xD;
          -  Patients who voluntarily do not want to participate in the study.&#xD;
&#xD;
          -  Patients who can not give informed consent under reasonable or vulnerable conditions.&#xD;
&#xD;
          -  Patients who present type I allergy to penicillin.&#xD;
&#xD;
          -  Patients who have scheduled surgeries combined with a discipline different to urology.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidad CES</name>
      <address>
        <city>Medellín</city>
        <state>Antioquia</state>
        <zip>00000</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jorge A Ramos, Ph.D Stud</last_name>
      <phone>+57 (4) 4440555</phone>
      <email>ramos.jorge@uces.edu.co</email>
    </contact>
    <investigator>
      <last_name>Jorge A Ramos, Ph.D Stud</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>January 22, 2018</last_update_submitted>
  <last_update_submitted_qc>January 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>CES University</investigator_affiliation>
    <investigator_full_name>Jorge Andres Ramos Castaneda</investigator_full_name>
    <investigator_title>Ph. D. student in Public Health</investigator_title>
  </responsible_party>
  <keyword>Urological Surgery</keyword>
  <keyword>Bacterial resistance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bacteriuria</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>Antibiotics, Antitubercular</mesh_term>
  </intervention_browse>
  <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/NCT03269604
org study id: 1075237598
nct id: NCT03269604
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Asymptomatic bacteriuria (AB) is the isolation of a bacterium in a sample of urine
      appropriately collected from a person who does not have signs or symptoms of urinary
      infection. It is common in diabetic women, in pregnant women, in men over 60 years and in
      patients with spinal cord injury.

      There is clinical evidence that AB should be treated in patients who will be operated on with
      urologic surgery because of the risk of presenting infectious complications; however, the
      timing of initiating antibiotic therapy has not been established, even in some studies the
      prophylaxis has been considered from one to seven days prior to the procedure, without
      determining the differences in the outcome for each one of the interventions and causing an
      undue and risky use of antibiotics.

      A randomized, parallel-design, single-masked clinical trial will be performed to compare and
      analysis the bloodstream infections, surgical site infections, readmissions and hospital stay
      in three intervention groups, 1) those receiving antibiotics during the previous 5 days to
      the procedure; 2) 3 days prior to the procedure; and 3) those who receive only a single dose
      of antibiotic on the day of the procedure.

      The main expected result is to identify the timing of initiation of antibiotic prophylaxis in
      urological procedures in patients with asymptomatic bacteriuria, with the purpose of
      diminishing the bloodstream and of the surgical site infections. If it is scientifically
      demonstrated that those patients who receive a single dose of antibiotic on the same day of
      the procedure, have the same safety and effectiveness compared to the other two groups, would
      reduce hospital stay, surgical waiting time and indiscriminate use of antibiotics that
      generate multidrug-resistant microorganisms, thus generating an impact on Public Health and
      on the quality of care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
masking description: A single blinding will be performed. To the database will be categorized the variable "duration of prophylaxis" so that the person in charge of analysing the data, does not know the true allocation of each of the participants. At the end of the tabulation and analysis of the data, the true allocation will be known.
measure: Bloodstream infection
time frame: 30 days
description: An infectious process characterized by the presence of some bacteria in the bloodstream. The patient should have one or more positive blood cultures, where the cultured organism is not related to an infection elsewhere, and has signs of infection, such as fever, hypotension or tachycardia.
measure: Surgical Site Infection:
time frame: 30 days
description: It can occur up to 30 days (or a year when a prosthetic component is involved) of a surgical procedure in some part of the body where it was manipulated in surgery. The SSI is classified as superficial, deep or organ space, depending on the type of tissue involved.
measure: Length of hospital stay
time frame: 30 days
description: Difference in days between the date of discharge and of the surgical procedure.
measure: Re-entry to hospitalization
time frame: 30 days
description: Re hospitalization after the surgical procedure due to SSI or bloodstream.
arm group label: Prophylactic antibiotic five days previous to the procedure
arm group type: Active Comparator
description: Prophylactic antibiotic during five days previous to the procedure.
arm group label: Prophylactic antibiotic three days previous to the procedure
arm group type: Active Comparator
description: Prophylactic antibiotic during three days previous to the procedure.
arm group label: Only a single dose of Prophylactic antibiotic
arm group type: Experimental
description: Only a single dose of Prophylactic antibiotic on the day of the procedure
intervention type: Procedure
intervention name: Prophylactic antibiotic during five days previous to the procedure
description: Prophylactic antibiotic during five days previous to the procedure.
arm group label: Prophylactic antibiotic five days previous to the procedure
intervention type: Procedure
intervention name: Prophylactic antibiotic during three days previous to the procedure
description: Prophylactic antibiotic during three days previous to the procedure.
arm group label: Prophylactic antibiotic three days previous to the procedure
intervention type: Procedure
intervention name: Only a single dose of Prophylactic antibiotic
description: This group will receive a single dose of antibiotic 90 ± 20 minutes prior to the start of the surgical procedure (incision)
arm group label: Only a single dose of Prophylactic antibiotic
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: Colombia
responsible party type: Sponsor-Investigator
investigator affiliation: CES University
investigator full name: Jorge Andres Ramos Castaneda
investigator title: Ph. D. student in Public Health
mesh term: Bacteriuria
mesh term: Anti-Bacterial Agents
mesh term: Antibiotics, Antitubercular
sharing ipd: Undecided