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/NCT05971537</url>
    </required_header>
    <id_info>
      <org_study_id>2016.513-T</org_study_id>
      <nct_id>NCT05971537</nct_id>
    </id_info>
    <brief_title>Clinical Trial on Antibiotic-Lock in Tenckhoff Catheter for Relasping and Repeat Peritonitis</brief_title>
    <official_title>Clinical Trial on Antibiotic-Lock in Tenckhoff Catheter for Relasping and Repeat Peritonitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alice Ho Miu Ling Nethersole Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alice Ho Miu Ling Nethersole Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Biofilm formation is an important cause of catheter-related infection. In hemodialysis, use&#xD;
        of an antibiotic-lock has been proven to be effective to manage such a complication with&#xD;
        preservation of the central venous catheter. In peritoneal dialysis, while biofilm has been&#xD;
        implicated in relapsing and repeat peritonitis, both of which are caused by the identical&#xD;
        bacteria as in their preceding peritonitis episode, no adjunctive measure has been proven to&#xD;
        be effective to eradicate the biofilm bacteria. As a result, Tenckhoff catheter removal is&#xD;
        the only recommended option for the patients suffering from relapsing or repeat peritonitis.&#xD;
        In this study, the investigators are going to investigate whether the use of an&#xD;
        antibiotic-lock can be useful to eradicate the biofilm in the Tenckhoff catheter to prevent&#xD;
        future episodes of peritonitis caused by the same organism.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        STUDY OBJECTIVES This study aims to evaluate whether the use of antibiotic-lock in the&#xD;
        Tenckhoff catheter can eradicate the biofilm within the catheter lumen, thereby preventing&#xD;
        further episodes of relapsing of repeat peritonitis without catheter removal.&#xD;
  &#xD;
        METHODS Total 46 patients are to be recruited&#xD;
  &#xD;
        When a PD patient, who has an episode of peritonitis treated successfully by IP antibiotics&#xD;
        within the preceding 12 weeks, returns to the investigator's unit for peritonitis, the&#xD;
        patient will be resumed on the same IP antibiotics treatment as in the last episode, while&#xD;
        waiting for the PD effluent culture results. In the investigators' experience, the turnaround&#xD;
        time of the microbiology report is usually 3-5 days. During this period, the patient should&#xD;
        be closely monitored for the response to the antibiotics. The patient will be eligible for&#xD;
        recruitment into this study if the same causative organism is confirmed subsequently. Another&#xD;
        scenario is the absence of peritonitis symptoms, including PDE leukocyte count &lt;100/mm3, yet&#xD;
        there is a persistent growth of bacteria from the PDE after completion of 2-week antibiotic&#xD;
        therapy. These patients are also eligible for study recruitment.&#xD;
  &#xD;
        After recruitment, the subject will be randomized into either the intervention arm or the&#xD;
        control arm in a 1:1 manner. In the control arm, appropriate IP antibiotics are to be&#xD;
        continued. The dosage and duration of antibiotics will fully follow the recommendation from&#xD;
        the latest International Society for Peritoneal Dialysis (ISPD) peritonitis guidelines (1).&#xD;
        In the case of persistent bacterial growth from PDE without peritonitis symptoms, IP&#xD;
        antibiotics will be extended up to 2 weeks more. In the intervention arm, in addition to the&#xD;
        appropriate IP antibiotics, an antibiotic-lock will be prepared by the same antibiotics. The&#xD;
        investigators will follow the suggested data used in hemodialysis catheter for the&#xD;
        concentration of different antibiotics to prepare the locking solution (2)&#xD;
  &#xD;
        All antibiotics are diluted into an appropriate amount of normal saline or water to achieve&#xD;
        the desired concentration. The resulting locking solution will be instilled precisely to fill&#xD;
        up the Tenckhoff catheter and the transfer set once a day by the renal nurses. Prior to that,&#xD;
        the existing PD solution is drained out first. As such, a &quot;dry abdomen&quot; is maintained during&#xD;
        antibiotic-lock dwelling in the Tenckhoff catheter. This is to ensure the antibiotic-lock&#xD;
        solution can be maintained within the catheter lumen for a prolonged period of time (3).&#xD;
        After a 6-hour dwell, the antibiotic-lock is drained out and usual PD schedule is resumed.&#xD;
        Such a daily application of antibiotic lock shall last until the course of IP antibiotics is&#xD;
        completed.&#xD;
  &#xD;
        RANDOMIZATION Randomization is carried out by drawing a consecutively numbered, sealed,&#xD;
        opaque envelope containing a form indicating whether the subject is randomized into the&#xD;
        intervention arm or control arm.&#xD;
  &#xD;
        STUDY PARAMETERS The patients' demographics, including the age, gender, body mass index, PD&#xD;
        vintage, etiology of end-stage renal disease, co-morbidities, together with the previous PD&#xD;
        peritonitis history will be retrieved. The causative organisms of the current relapsing or&#xD;
        repeat peritonitis are recorded.&#xD;
  &#xD;
        After recruitment into the study and the peritonitis episode has been cured successfully, all&#xD;
        subjects will be followed for up to 6 months after completion of their IP antibiotics&#xD;
        treatment.&#xD;
  &#xD;
        TERMINATION OF STUDY The subjects will be out from the trial when they have completed the&#xD;
        study, or before the end of the study if their peritonitis is refractory to appropriate IP&#xD;
        antibiotics rendering a need of timely Tenckhoff catheter removal, or at anytime the subjects&#xD;
        decide to withdraw from the trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">July 28, 2023</start_date>
    <completion_date type="Anticipated">October 2026</completion_date>
    <primary_completion_date type="Anticipated">October 2026</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>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>developement of relapsing or repeat peritonitis</measure>
      <time_frame>6 month</time_frame>
      <description>Development of relapsing peritonitis (within 4 weeks of completion of antibiotics) or repeat peritonitis (between 4 to 12 weeks of completion of antibiotics) again</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>development of peritonitis due to same organism, beyond 12 weeks</measure>
      <time_frame>6 month</time_frame>
      <description>Development of peritonitis due to the same organism, beyond 12 weeks of completion of antibiotics</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">46</enrollment>
    <condition>Peritoneal Dialysis-associated Peritonitis</condition>
    <arm_group>
      <arm_group_label>intervention arm</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>in addition to the appropriate IP antibiotics, an antibiotic-lock will be prepared by the same antibiotics. We will follow the suggested data used in hemodialysis catheter for the concentration of different antibiotics to prepare the locking solution The resulting locking solution will be instilled precisely to fill up the Tenckhoff catheter and the transfer set once a day. Prior to that, the existing PD solution is drained out first. As such, a &quot;dry abdomen&quot; is maintained during antibiotic-lock dwelling in the Tenckhoff catheter. This is to ensure the antibiotic-lock solution can be maintained within the catheter lumen for a prolonged period of time After a 6-hour dwell, the antibiotic-lock is drained out and usual PD schedule is resumed. Such a daily application of antibiotic lock shall last until the course of IP antibiotics is completed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control arm</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In the control arm, appropriate IP antibiotics are to be continued. The dosage and duration of antibiotics will fully follow the recommendation from the latest International Society for Peritoneal Dialysis (ISPD) peritonitis guidelines&#xD;
  *For the subjects in the control arm who reach the defined primary end-point, they will automatically undergo crossover to the intervention arm to receive standard IP antibiotics together with the intra-catheter antibiotic-lock. They will be followed for another 6 months subsequently.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>antibiotic lock</intervention_name>
      <description>In the intervention arm, in addition to the appropriate IP antibiotics, an antibiotic-lock will be prepared by the same antibiotics. We will follow the suggested data used in hemodialysis catheter for the concentration of different antibiotics to prepare the locking solution . Some commonly used antibiotics for the treatment of PD peritonitis with their suggested concentrations in the antibiotic-lock are quoted as below:&#xD;
  Cefazolin 10mg/mL Ceftazidime 10mg/mL Vancomycin 10mg/mL Gentamicin 5mg/mL Tienam 50mg/mL</description>
      <arm_group_label>intervention arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>conventional IP antibiotics</intervention_name>
      <description>In the control arm, appropriate IP antibiotics are to be continued. The dosage and duration of antibiotics will fully follow the recommendation from the latest International Society for Peritoneal Dialysis (ISPD) peritonitis guidelines</description>
      <arm_group_label>control arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  PD patients who suffer from Either relapsing peritonitis (within 4 weeks of completion&#xD;
               of antibiotics) or repeat peritonitis (between 4 to 12 weeks of completion of&#xD;
               antibiotics), in which the causative organism is confirmed to be identical to the one&#xD;
               in the preceding peritonitis episode, or Persistent growth of bacteria from PD&#xD;
               effluent (PDE) after completion of standard 2-week antibiotic treatment, despite the&#xD;
               resolution of symptoms and PDE leukocyte count &lt;100/mm3&#xD;
  &#xD;
            -  Age &gt; 18 years old&#xD;
  &#xD;
            -  informed consent available&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who do not respond to the appropriate IP antibiotics, evident by the&#xD;
               persistence of peritonitis symptoms in which they should be referred for timely&#xD;
               Tenchkoff catheter removal&#xD;
  &#xD;
            -  Fungal or mycobacterial PD peritonitis&#xD;
  &#xD;
            -  Co-existing exit site or tunnel tract infection&#xD;
  &#xD;
            -  The presence of Tenckhoff catheter drainage dysfunction&#xD;
  &#xD;
            -  &lt;= 3 years old&#xD;
  &#xD;
            -  Pregnant patients&#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>ping kwan chan</last_name>
      <role>Principal Investigator</role>
      <affiliation>Alice Ho Miu Ling Nethersole Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ping Kwan Chan</last_name>
      <phone>26892000</phone>
      <email>cpk618a@ha.org.hk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Alice Ho Miu Ling Nethersole Hospital</name>
        <address>
          <city>Tai Po</city>
          <country>Hong Kong</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>ping kwan chan</last_name>
        <phone>26892000</phone>
        <email>cpk618a@ha.org.hk</email>
      </contact>
    </location>
    <location_countries>
      <country>Hong Kong</country>
    </location_countries>
    <reference>
      <citation>Li PK, Szeto CC, Piraino B, de Arteaga J, Fan S, Figueiredo AE, Fish DN, Goffin E, Kim YL, Salzer W, Struijk DG, Teitelbaum I, Johnson DW. ISPD Peritonitis Recommendations: 2016 Update on Prevention and Treatment. Perit Dial Int. 2016 Sep 10;36(5):481-508. doi: 10.3747/pdi.2016.00078. Epub 2016 Jun 9. No abstract available. Erratum In: Perit Dial Int. 2018 Jul-Aug;38(4):313.</citation>
      <PMID>27282851</PMID>
    </reference>
    <reference>
      <citation>Justo JA, Bookstaver PB. Antibiotic lock therapy: review of technique and logistical challenges. Infect Drug Resist. 2014 Dec 12;7:343-63. doi: 10.2147/IDR.S51388. eCollection 2014.</citation>
      <PMID>25548523</PMID>
    </reference>
    <reference>
      <citation>Wong SS, Lau WY, Chan PK, Wan CK, Cheng YL. Extended Experience in the Use of Antibiotic Lock for Eradication of Biofilm Bacteria on Tenckhoff Catheter. Perit Dial Int. 2019 Mar-Apr;39(2):187-190. doi: 10.3747/pdi.2018.00098.</citation>
      <PMID>30858288</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Alice Ho Miu Ling Nethersole Hospital</investigator_affiliation>
      <investigator_full_name>chan ping kwan</investigator_full_name>
      <investigator_title>Associate consultant</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peritonitis</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>No</sharing_ipd>
    </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/NCT05971537
  org study id: 2016.513-T
  nct id: NCT05971537
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Biofilm formation is an important cause of catheter-related infection. In hemodialysis, use
        of an antibiotic-lock has been proven to be effective to manage such a complication with
        preservation of the central venous catheter. In peritoneal dialysis, while biofilm has been
        implicated in relapsing and repeat peritonitis, both of which are caused by the identical
        bacteria as in their preceding peritonitis episode, no adjunctive measure has been proven to
        be effective to eradicate the biofilm bacteria. As a result, Tenckhoff catheter removal is
        the only recommended option for the patients suffering from relapsing or repeat peritonitis.
        In this study, the investigators are going to investigate whether the use of an
        antibiotic-lock can be useful to eradicate the biofilm in the Tenckhoff catheter to prevent
        future episodes of peritonitis caused by the same organism.
  STUDY OBJECTIVES This study aims to evaluate whether the use of antibiotic-lock in the
        Tenckhoff catheter can eradicate the biofilm within the catheter lumen, thereby preventing
        further episodes of relapsing of repeat peritonitis without catheter removal.
  
        METHODS Total 46 patients are to be recruited
  
        When a PD patient, who has an episode of peritonitis treated successfully by IP antibiotics
        within the preceding 12 weeks, returns to the investigator's unit for peritonitis, the
        patient will be resumed on the same IP antibiotics treatment as in the last episode, while
        waiting for the PD effluent culture results. In the investigators' experience, the turnaround
        time of the microbiology report is usually 3-5 days. During this period, the patient should
        be closely monitored for the response to the antibiotics. The patient will be eligible for
        recruitment into this study if the same causative organism is confirmed subsequently. Another
        scenario is the absence of peritonitis symptoms, including PDE leukocyte count <100/mm3, yet
        there is a persistent growth of bacteria from the PDE after completion of 2-week antibiotic
        therapy. These patients are also eligible for study recruitment.
  
        After recruitment, the subject will be randomized into either the intervention arm or the
        control arm in a 1:1 manner. In the control arm, appropriate IP antibiotics are to be
        continued. The dosage and duration of antibiotics will fully follow the recommendation from
        the latest International Society for Peritoneal Dialysis (ISPD) peritonitis guidelines (1).
        In the case of persistent bacterial growth from PDE without peritonitis symptoms, IP
        antibiotics will be extended up to 2 weeks more. In the intervention arm, in addition to the
        appropriate IP antibiotics, an antibiotic-lock will be prepared by the same antibiotics. The
        investigators will follow the suggested data used in hemodialysis catheter for the
        concentration of different antibiotics to prepare the locking solution (2)
  
        All antibiotics are diluted into an appropriate amount of normal saline or water to achieve
        the desired concentration. The resulting locking solution will be instilled precisely to fill
        up the Tenckhoff catheter and the transfer set once a day by the renal nurses. Prior to that,
        the existing PD solution is drained out first. As such, a "dry abdomen" is maintained during
        antibiotic-lock dwelling in the Tenckhoff catheter. This is to ensure the antibiotic-lock
        solution can be maintained within the catheter lumen for a prolonged period of time (3).
        After a 6-hour dwell, the antibiotic-lock is drained out and usual PD schedule is resumed.
        Such a daily application of antibiotic lock shall last until the course of IP antibiotics is
        completed.
  
        RANDOMIZATION Randomization is carried out by drawing a consecutively numbered, sealed,
        opaque envelope containing a form indicating whether the subject is randomized into the
        intervention arm or control arm.
  
        STUDY PARAMETERS The patients' demographics, including the age, gender, body mass index, PD
        vintage, etiology of end-stage renal disease, co-morbidities, together with the previous PD
        peritonitis history will be retrieved. The causative organisms of the current relapsing or
        repeat peritonitis are recorded.
  
        After recruitment into the study and the peritonitis episode has been cured successfully, all
        subjects will be followed for up to 6 months after completion of their IP antibiotics
        treatment.
  
        TERMINATION OF STUDY The subjects will be out from the trial when they have completed the
        study, or before the end of the study if their peritonitis is refractory to appropriate IP
        antibiotics rendering a need of timely Tenckhoff catheter removal, or at anytime the subjects
        decide to withdraw from the trial.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: developement of relapsing or repeat peritonitis
  time frame: 6 month
  description: Development of relapsing peritonitis (within 4 weeks of completion of antibiotics) or repeat peritonitis (between 4 to 12 weeks of completion of antibiotics) again
  measure: development of peritonitis due to same organism, beyond 12 weeks
  time frame: 6 month
  description: Development of peritonitis due to the same organism, beyond 12 weeks of completion of antibiotics
  arm group label: intervention arm
  arm group type: Active Comparator
  description: in addition to the appropriate IP antibiotics, an antibiotic-lock will be prepared by the same antibiotics. We will follow the suggested data used in hemodialysis catheter for the concentration of different antibiotics to prepare the locking solution The resulting locking solution will be instilled precisely to fill up the Tenckhoff catheter and the transfer set once a day. Prior to that, the existing PD solution is drained out first. As such, a "dry abdomen" is maintained during antibiotic-lock dwelling in the Tenckhoff catheter. This is to ensure the antibiotic-lock solution can be maintained within the catheter lumen for a prolonged period of time After a 6-hour dwell, the antibiotic-lock is drained out and usual PD schedule is resumed. Such a daily application of antibiotic lock shall last until the course of IP antibiotics is completed.
  arm group label: control arm
  arm group type: Other
  description: In the control arm, appropriate IP antibiotics are to be continued. The dosage and duration of antibiotics will fully follow the recommendation from the latest International Society for Peritoneal Dialysis (ISPD) peritonitis guidelines
  *For the subjects in the control arm who reach the defined primary end-point, they will automatically undergo crossover to the intervention arm to receive standard IP antibiotics together with the intra-catheter antibiotic-lock. They will be followed for another 6 months subsequently.
  intervention type: Drug
  intervention name: antibiotic lock
  description: In the intervention arm, in addition to the appropriate IP antibiotics, an antibiotic-lock will be prepared by the same antibiotics. We will follow the suggested data used in hemodialysis catheter for the concentration of different antibiotics to prepare the locking solution . Some commonly used antibiotics for the treatment of PD peritonitis with their suggested concentrations in the antibiotic-lock are quoted as below:
  Cefazolin 10mg/mL Ceftazidime 10mg/mL Vancomycin 10mg/mL Gentamicin 5mg/mL Tienam 50mg/mL
  arm group label: intervention arm
  intervention type: Drug
  intervention name: conventional IP antibiotics
  description: In the control arm, appropriate IP antibiotics are to be continued. The dosage and duration of antibiotics will fully follow the recommendation from the latest International Society for Peritoneal Dialysis (ISPD) peritonitis guidelines
  arm group label: control arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: ping kwan chan
  role: Principal Investigator
  affiliation: Alice Ho Miu Ling Nethersole Hospital
  last name: Ping Kwan Chan
  phone: 26892000
  email: cpk618a@ha.org.hk
  facility: 
  status: Recruiting
  contact: 
  country: Hong Kong
  citation: Li PK, Szeto CC, Piraino B, de Arteaga J, Fan S, Figueiredo AE, Fish DN, Goffin E, Kim YL, Salzer W, Struijk DG, Teitelbaum I, Johnson DW. ISPD Peritonitis Recommendations: 2016 Update on Prevention and Treatment. Perit Dial Int. 2016 Sep 10;36(5):481-508. doi: 10.3747/pdi.2016.00078. Epub 2016 Jun 9. No abstract available. Erratum In: Perit Dial Int. 2018 Jul-Aug;38(4):313.
  PMID: 27282851
  citation: Justo JA, Bookstaver PB. Antibiotic lock therapy: review of technique and logistical challenges. Infect Drug Resist. 2014 Dec 12;7:343-63. doi: 10.2147/IDR.S51388. eCollection 2014.
  PMID: 25548523
  citation: Wong SS, Lau WY, Chan PK, Wan CK, Cheng YL. Extended Experience in the Use of Antibiotic Lock for Eradication of Biofilm Bacteria on Tenckhoff Catheter. Perit Dial Int. 2019 Mar-Apr;39(2):187-190. doi: 10.3747/pdi.2018.00098.
  PMID: 30858288
  responsible party type: Principal Investigator
  investigator affiliation: Alice Ho Miu Ling Nethersole Hospital
  investigator full name: chan ping kwan
  investigator title: Associate consultant
  mesh term: Peritonitis
  mesh term: Anti-Bacterial Agents
  mesh term: Antibiotics, Antitubercular
  sharing ipd: No