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/NCT06017479</url>
    </required_header>
    <id_info>
      <org_study_id>22-11-1343</org_study_id>
      <nct_id>NCT06017479</nct_id>
    </id_info>
    <brief_title>Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic for UTI Prevention</brief_title>
    <official_title>Effectiveness of Single Dose Fosfomycin and Single Dose Levofloxacin as Pre-urodynamic Antibiotic Prophylaxis for Urinary Tract Infection Prevention in Post-Urodynamic Examination</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Indonesia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Indonesia 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>
        The goal of this clinical trial is to compare the use of single dose fosfomycin and single&#xD;
        dose levofloxacin as pre-urodynamic antibiotic prophylaxis for urinary tract infection&#xD;
        prevention post-urodynamic in patients with lower urinary tract symptoms. The main&#xD;
        question[s] it aims to answer are:&#xD;
  &#xD;
          -  What is the difference between the effectiveness of administering a single dose of&#xD;
             fosfomycin and levofloxacin prior to the procedure in terms of the incidence rate of&#xD;
             urinary tract infection (UTI) post-urodynamic examination?&#xD;
  &#xD;
          -  What is the incidence rate of UTI in the administration of single-dose fosfomycin and&#xD;
             levofloxacin prior to the procedure on the incidence rate of UTI post-urodynamic&#xD;
             examination? Participants fulfilling the inclusion criteria will be taken their history&#xD;
             and vital signs and consume either fosfomycin or levofloxacin based on the randomisation&#xD;
             prior to urodynamic procedure. Afterwards, participants will undergo urine analysis 4&#xD;
             days post urodynamic to evaluate if there's any urinary tract infection. If there is any&#xD;
             bacteria present, the sample will be cultured to identify bacteria found in the urine.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study employs a single-blinded randomized clinical trial design to compare the&#xD;
        proportion of UTI post-urodynamic examination between the group receiving single-dose&#xD;
        levofloxacin pre-urodynamic examination and the group receiving levofloxacin post-urodynamic&#xD;
        examination for three days. The target population is patients undergoing urodynamic&#xD;
        examination at Dr. Cipto Mangunkusumo National Referral Hospital, Persahabatan National&#xD;
        Hospital, and Siloam Asri Hospital. The total sample size in this study is 100 patients. On&#xD;
        the fourth day post-urodynamic examination, urinalysis and urine culture are performed to&#xD;
        determine the diagnosis of UTI. To analyze the association between UTI and therapy groups, a&#xD;
        chi-square test is used. Results are considered statistically significant if p &lt; 0.05.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 30, 2022</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <phase>Phase 1/Phase 2</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>
      <intervention_model_description>This study is an experimental study with a single-blinded randomized clinical trial design to compare the proportion of UTIs in a group of patients receiving fosfomycin 3 g and patients receiving levofloxacin 500 mg single dose one hour before urodynamic examination. To determine the sample treatment group, blocked randomization technique is used in this study.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>This study uses a single-blinded design because the outcome assessed in this study is urinalysis which is the objective outcome. The urinalysis evaluator is blinded to the drug regimen obtained by the research subjects.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participant With Urinary Tract Infection</measure>
      <time_frame>4 days post-urodynamic procedure</time_frame>
      <description>Urinary tract infection is defined based on the result of urinalysis in which one of the following condition present : leukocyes &gt; 5 / high power field, bacteria positive, nitrite positive, and/or positive leukocyte esterase</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Urological System Complication of Procedure</condition>
    <condition>Urinary Tract Infections</condition>
    <arm_group>
      <arm_group_label>Pre-urodynamic Fosfomycin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Fosfomycin 3 g single dosage 1 hour before the urodynamic examination</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pre-urodynamic Levofloxacin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Fosfomycin 3000 MG</intervention_name>
      <description>Fosfomycin 3 g single dosage 1 hour before the urodynamic examination</description>
      <arm_group_label>Pre-urodynamic Fosfomycin</arm_group_label>
      <other_name>Monuril</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Levofloxacin 500mg</intervention_name>
      <description>Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination</description>
      <arm_group_label>Pre-urodynamic Levofloxacin</arm_group_label>
      <other_name>Levaquin</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male/female patients &gt; 18 years who have indications for urodynamics&#xD;
  &#xD;
            -  Willing to participate in research&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Allergy to levofloxacin&#xD;
  &#xD;
            -  Allergy to fosfomycin&#xD;
  &#xD;
            -  History of taking antibiotics in 1 month&#xD;
  &#xD;
            -  Pregnant&#xD;
  &#xD;
            -  Uncontrolled DM&#xD;
  &#xD;
            -  Use of urinary catheter&#xD;
  &#xD;
            -  Having a UTI before urodynamics, based on clinical symptoms and urine examination&#xD;
               results&#xD;
  &#xD;
            -  Refuse to participate in research&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Harrina E Rahardjo, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Indonesia University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Harrina E Rahardjo, Professor</last_name>
      <phone>+62 816 825 226</phone>
      <email>harrinaerlianti@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cipto Mangunkusumo Hospital</name>
        <address>
          <city>Jakarta Pusat</city>
          <state>DKI Jakarta</state>
          <zip>10430</zip>
          <country>Indonesia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Harrina E Rahardjo, Professor</last_name>
        <phone>+62816825226</phone>
        <email>harrinaerlianti@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <reference>
      <citation>Rahardjo HE, Tirtayasa PM, Afriansyah A, Parikesit D, Akbar MI. The Effectiveness of a Three Day Course Antibiotic Post-urodynamic Study in Preventing Lower Urinary Tract Infection. Acta Med Indones. 2016 Apr;48(2):84-90.</citation>
      <PMID>27550876</PMID>
    </reference>
    <reference>
      <citation>Chu CM, Lowder JL. Diagnosis and treatment of urinary tract infections across age groups. Am J Obstet Gynecol. 2018 Jul;219(1):40-51. doi: 10.1016/j.ajog.2017.12.231. Epub 2018 Jan 2.</citation>
      <PMID>29305250</PMID>
    </reference>
    <reference>
      <citation>Fajfr M, Balik M, Cermakova E, Bostik P. Effective Treatment for Uncomplicated Urinary Tract Infections with Oral Fosfomycin, Single Center Four Year Retrospective Study. Antibiotics (Basel). 2020 Aug 13;9(8):511. doi: 10.3390/antibiotics9080511.</citation>
      <PMID>32823650</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Indonesia University</investigator_affiliation>
      <investigator_full_name>dr. Harrina Erlianti Rahadjo, Sp.U(K), PhD</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>urodynamic</keyword>
    <keyword>urinary tract infections</keyword>
    <keyword>fosfomycin</keyword>
    <keyword>levofloxacin</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</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>Levofloxacin</mesh_term>
      <mesh_term>Fosfomycin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>These are the study protocol used in this study</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Immediately following publication. No end date</ipd_time_frame>
      <ipd_access_criteria>Anyone who wishes to access the data</ipd_access_criteria>
    </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/NCT06017479
  org study id: 22-11-1343
  nct id: NCT06017479
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare the use of single dose fosfomycin and single
        dose levofloxacin as pre-urodynamic antibiotic prophylaxis for urinary tract infection
        prevention post-urodynamic in patients with lower urinary tract symptoms. The main
        question[s] it aims to answer are:
  
          -  What is the difference between the effectiveness of administering a single dose of
             fosfomycin and levofloxacin prior to the procedure in terms of the incidence rate of
             urinary tract infection (UTI) post-urodynamic examination?
  
          -  What is the incidence rate of UTI in the administration of single-dose fosfomycin and
             levofloxacin prior to the procedure on the incidence rate of UTI post-urodynamic
             examination? Participants fulfilling the inclusion criteria will be taken their history
             and vital signs and consume either fosfomycin or levofloxacin based on the randomisation
             prior to urodynamic procedure. Afterwards, participants will undergo urine analysis 4
             days post urodynamic to evaluate if there's any urinary tract infection. If there is any
             bacteria present, the sample will be cultured to identify bacteria found in the urine.
  This study employs a single-blinded randomized clinical trial design to compare the
        proportion of UTI post-urodynamic examination between the group receiving single-dose
        levofloxacin pre-urodynamic examination and the group receiving levofloxacin post-urodynamic
        examination for three days. The target population is patients undergoing urodynamic
        examination at Dr. Cipto Mangunkusumo National Referral Hospital, Persahabatan National
        Hospital, and Siloam Asri Hospital. The total sample size in this study is 100 patients. On
        the fourth day post-urodynamic examination, urinalysis and urine culture are performed to
        determine the diagnosis of UTI. To analyze the association between UTI and therapy groups, a
        chi-square test is used. Results are considered statistically significant if p < 0.05.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study is an experimental study with a single-blinded randomized clinical trial design to compare the proportion of UTIs in a group of patients receiving fosfomycin 3 g and patients receiving levofloxacin 500 mg single dose one hour before urodynamic examination. To determine the sample treatment group, blocked randomization technique is used in this study.
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  masking description: This study uses a single-blinded design because the outcome assessed in this study is urinalysis which is the objective outcome. The urinalysis evaluator is blinded to the drug regimen obtained by the research subjects.
  measure: Number of Participant With Urinary Tract Infection
  time frame: 4 days post-urodynamic procedure
  description: Urinary tract infection is defined based on the result of urinalysis in which one of the following condition present : leukocyes > 5 / high power field, bacteria positive, nitrite positive, and/or positive leukocyte esterase
  arm group label: Pre-urodynamic Fosfomycin
  arm group type: Experimental
  description: Fosfomycin 3 g single dosage 1 hour before the urodynamic examination
  arm group label: Pre-urodynamic Levofloxacin
  arm group type: Experimental
  description: Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
  intervention type: Drug
  intervention name: Fosfomycin 3000 MG
  description: Fosfomycin 3 g single dosage 1 hour before the urodynamic examination
  arm group label: Pre-urodynamic Fosfomycin
  other name: Monuril
  intervention type: Drug
  intervention name: Levofloxacin 500mg
  description: Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination
  arm group label: Pre-urodynamic Levofloxacin
  other name: Levaquin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Harrina E Rahardjo, Professor
  role: Principal Investigator
  affiliation: Indonesia University
  last name: Harrina E Rahardjo, Professor
  phone: +62 816 825 226
  email: harrinaerlianti@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Indonesia
  citation: Rahardjo HE, Tirtayasa PM, Afriansyah A, Parikesit D, Akbar MI. The Effectiveness of a Three Day Course Antibiotic Post-urodynamic Study in Preventing Lower Urinary Tract Infection. Acta Med Indones. 2016 Apr;48(2):84-90.
  PMID: 27550876
  citation: Chu CM, Lowder JL. Diagnosis and treatment of urinary tract infections across age groups. Am J Obstet Gynecol. 2018 Jul;219(1):40-51. doi: 10.1016/j.ajog.2017.12.231. Epub 2018 Jan 2.
  PMID: 29305250
  citation: Fajfr M, Balik M, Cermakova E, Bostik P. Effective Treatment for Uncomplicated Urinary Tract Infections with Oral Fosfomycin, Single Center Four Year Retrospective Study. Antibiotics (Basel). 2020 Aug 13;9(8):511. doi: 10.3390/antibiotics9080511.
  PMID: 32823650
  responsible party type: Principal Investigator
  investigator affiliation: Indonesia University
  investigator full name: dr. Harrina Erlianti Rahadjo, Sp.U(K), PhD
  investigator title: Professor
  mesh term: Infections
  mesh term: Urinary Tract Infections
  mesh term: Levofloxacin
  mesh term: Fosfomycin
  sharing ipd: Yes
  ipd description: These are the study protocol used in this study
  ipd info type: Study Protocol
  ipd time frame: Immediately following publication. No end date
  ipd access criteria: Anyone who wishes to access the data