<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT2016101730345N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-10-30</date_registration>
      <primary_sponsor>CHU de Poitiers</primary_sponsor>
      <public_title>Daptomycin at high dose for hemodialysis patient</public_title>
      <acronym>DaptoHD</acronym>
      <scientific_title>Pharmacokinetics and safety of high-dose intravenous daptomycin in infected hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-08-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/24137</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: Pharmacokinetics.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>Catheter related blood stream infection.</hc_freetext>
      <i_freetext>Patient on hemodialysis (regimen 2/2/3) with suspected CRBSI will be treated with Daptomycin at 10mg/kg immediately after dialysis (2 minutes intravenous infusion). Area under curve for 48h (AUC48h), AUC72h, Cmax, C0.5h (30 min after infusion) and Cmin will be determined. Pharmacokinetics parameters will be documented during the first 3 Daptomycin injections with blood sampling at 2 min, 1h, 2h, 4h, 12h, 24h, 44h (immediately before the next dialysis) and at 48h (immediately after completion of dialysis and before the next dose) after each injection. A 72h point will be added if the interval between two subsequent hemodialysis sessions and therefore also the Daptomycin injection interval of Daptomycin is 72 h. Treatment will be adapted according to microbiological results.Treatment duration is determined by the investigator according to medical need and microbiology.&#13;
Catheter removal will be determined by the investigator according to infection severity, microbiology when available (systematic removal in case of Candida or Pseudomonas aeruginosa infections), and possibilities to create another vascular access if needed (hemodialysis catheters being vital for these patients, a conservative approach can be used as described by ERA-EDTA guidelines in 2007 and the Infectious Diseases Society of America in 2009). If the catheter is left in place, antiseptic lock (taurolidin) will be used at the end of each hemodialysis session..</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Guillaume Béraud</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>2, rue de la Milétrie</address>
        <city>POITIERS</city>
        <country1>France</country1>
        <zip>86000</zip>
        <telephone>00549444444</telephone>
        <email>guillaume.beraud@chu-poitiers.fr</email>
        <affiliation>CHU de Poitiers</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Guillaume Béraud</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>2, rue de la Milétrie</address>
        <city>Poitiers</city>
        <country1>France</country1>
        <zip>86000</zip>
        <telephone>0033549444444</telephone>
        <email>guillaume.beraud@chu-poitiers.fr</email>
        <affiliation>CHU de Poitiers</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>France</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion: patients &gt; 18 years, requiring conventional hemodialysis for chronic renal failure hospitalized at the University Hospital of Poitiers (CHU de Poitiers) and presenting a CRBSI.&#13;
Exclusion: pregnant or breeding women, pneumonia, septic shock (which may affect pharmacokinetic parameters and therefore not represent the principal hemodialysis population); CPK &gt;3ULN; known hypersensitivity to Daptomycin.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T80-211</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Catheter-related bloodstream infection (CRBSI)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patient on hemodialysis (regimen 2/2/3) with suspected CRBSI will be treated with Daptomycin at 10mg/kg immediately after dialysis (2 minutes intravenous infusion). Area under curve for 48h (AUC48h), AUC72h, Cmax, C0.5h (30 min after infusion) and Cmin will be determined. Pharmacokinetics parameters will be documented during the first 3 Daptomycin injections with blood sampling at 2 min, 1h, 2h, 4h, 12h, 24h, 44h (immediately before the next dialysis) and at 48h (immediately after completion of dialysis and before the next dose) after each injection. A 72h point will be added if the interval between two subsequent hemodialysis sessions and therefore also the Daptomycin injection interval of Daptomycin is 72 h. Treatment will be adapted according to microbiological results.Treatment duration is determined by the investigator according to medical need and microbiology.&#13;
Catheter removal will be determined by the investigator according to infection severity, microbiology when available (systematic removal in case of Candida or Pseudomonas aeruginosa infections), and possibilities to create another vascular access if needed (hemodialysis catheters being vital for these patients, a conservative approach can be used as described by ERA-EDTA guidelines in 2007 and the Infectious Diseases Society of America in 2009). If the catheter is left in place, antiseptic lock (taurolidin) will be used at the end of each hemodialysis session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pharmacokinetics of Daptomycin at 10 mg/kg after dialysisin conventional hemodialysis in patients with central catheter related infections. Timepoint: 1 week. Method of measurement: Cmax, Cmin, AUC.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>To evaluate clinical parameters (physical examination, vital signs and temperature) in order to monitor infection evolution and side effects in relation to Daptomycin treatment. Timepoint: 2 weeks. Method of measurement: Cinical examination.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>CHU de Poitiers</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-02-01</approval_date>
        <contact_name>CPP Ouest III</contact_name>
        <contact_address>CHU de Poitiers Poitiers  France</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
