<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/NCT01693887</url>
  </required_header>
  <id_info>
    <org_study_id>ITRFUN4056</org_study_id>
    <nct_id>NCT01693887</nct_id>
  </id_info>
  <brief_title>Treatment Method Research of Invasive Pulmonary Fungal Infection</brief_title>
  <acronym>4056</acronym>
  <official_title>A Comparative Study About Empirical Therapy and Preemptive Therapy to Invasive Pulmonary Fungal Infection ICU Patients in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West China Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to Comparison clinical efficiency with IPFI patients who treated&#xD;
      by different protocols(empirical therapy or preemptive therapy) in ICU.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      a multicenter study ( a total of 2411 person-time ) found In the United States in 205,&#xD;
      antifungal therapy in empirical therapy, preemptive therapy, target therapy of respectively&#xD;
      44%, 43%, 12%. While the existing on preemptive therapy and empiric treatment comparative&#xD;
      study shows, the survival rate of the patients without differences, cost and application of&#xD;
      antifungal drugs are relatively more in empirical therapy. These findings of differences, is&#xD;
      due to the different research forecast model, treatment options vary widely, and are without&#xD;
      a prospective multicenter study of verification. Initiation of antifungal therapy time and&#xD;
      antifungal drug of choice is affected by many factors, including the risk stratification of&#xD;
      patients, clinical manifestations, bacterial infection of evidence and non interventional&#xD;
      diagnosis method results. How to grasp the opportunity to treat the fungal infections by&#xD;
      empirical therapy or preemptive therapy that has plagued the global clinical doctors. The&#xD;
      purpose of this study is aimed at the large scale prospective, multicenter study method to&#xD;
      China, severe invasive pulmonary fungal infection of the empiric treatment with preemptive&#xD;
      therapy for clinical contrast research, exploration of fungal treatment time and plan, to&#xD;
      establish China's own optimal antifungal treatment options, are reduced in patients with&#xD;
      severe fungal infection harm and increase the rate of successful treatment with&#xD;
      evidence-based medical evidence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study difficulty is more serious than expected. The budget isn't enough.&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">7</enrollment>
  <condition>IFI</condition>
  <arm_group>
    <arm_group_label>empirical therapy</arm_group_label>
    <description>immediate initiation of antifungal therapy; Itraconazole :1-14day,iv；(400mg/day bid 1-2day, 200mg/day q.d 3-14day) 15-28day,p.o(400mg/day bid)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>preemptive therapy</arm_group_label>
    <description>Dynamic monitoring of fungal infection, initiation antifungal therapy when clinical diagnosis ( microbial + experiment +, G/GM, CT typical change ) approveled in two weeks Itraconazole :1-14day,iv；(400mg/day bid 1-2day, 200mg/day q.d 3-14day) 15-28day,p.o(400mg/day bid) If within two weeks without obtaining positive results, researchers determine whether initiation of antifungal therapy。</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        suspected Pulmonary invasive fungal Infection in ICU patients with Mechanical Ventilation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. More than 18 years old ，male or female&#xD;
&#xD;
          2. Expected the time of staying in ICU longer than 72 hours and the duration of&#xD;
             mechanical ventilation for more than 48 hours&#xD;
&#xD;
          3. Pulmonary infection according to, axillary temperature≥ 37℃, using broad-spectrum&#xD;
             antibiotics more than 72 hours, no better or worse&#xD;
&#xD;
          4. Candida score greater than or equal to 3&#xD;
&#xD;
          5. Child-bearing women, urine pregnancy test must be negative when screening and agreed&#xD;
             to adopt safe and effective contraceptive measures in the process&#xD;
&#xD;
          6. Male subjects must be guaranteed to use dual physical methods of contraception&#xD;
             contraceptive and sperm donation, from starting to after 30days ending treatment&#xD;
&#xD;
          7. Subjects ( or their legal representatives） have signed the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosed with invasive fungal infection by any of the following means at the time of&#xD;
             admission 1）Proved deep fungal infection by histopathology 2）Peripheral blood culture&#xD;
             fungi positive at least 1 time 3）Specimens from sterile sites of culture positive (&#xD;
             cerebrospinal fluid, pleural effusion and ascites）&#xD;
&#xD;
          2. Renal insufficiency, creatinine clearance &lt; 30ml/min&#xD;
&#xD;
          3. Active liver disease or suspected drug induced liver injury&#xD;
&#xD;
          4. Pregnant and lactating women&#xD;
&#xD;
          5. With imidazole or pyrrolic drug allergy or intolerance or have contraindications.&#xD;
&#xD;
          6. Not fit into the group by comprehensive judgment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>yan kang, director</last_name>
    <role>Principal Investigator</role>
    <affiliation>West China Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>xiao bo huang, director</last_name>
    <role>Study Director</role>
    <affiliation>Sichuan Provincial People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>chuan zhang, director</last_name>
    <role>Study Director</role>
    <affiliation>Third people's Hospital of Chengdu City</affiliation>
  </overall_official>
  <overall_official>
    <last_name>di-fen wang, director</last_name>
    <role>Study Director</role>
    <affiliation>Affiliated Hospital of Guiyang Medical College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Affiliated Hospital of Guiyang Medical College</name>
      <address>
        <city>Guiyang</city>
        <state>Guizhou</state>
        <zip>550004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Third people's Hospital of Chengdu City</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sichuan provincial people's hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610071</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>December 10, 2015</last_update_submitted>
  <last_update_submitted_qc>December 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West China Hospital</investigator_affiliation>
    <investigator_full_name>yan kang</investigator_full_name>
    <investigator_title>director（ICU）</investigator_title>
  </responsible_party>
  <keyword>IFI</keyword>
  <keyword>empirical therapy</keyword>
  <keyword>preemptive therapy</keyword>
  <keyword>Itraconazole</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycoses</mesh_term>
    <mesh_term>Lung Diseases, Fungal</mesh_term>
  </condition_browse>
  <!-- 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/NCT01693887
org study id: ITRFUN4056
nct id: NCT01693887
lead sponsor: 
has dmc: Yes
The purpose of this study is to Comparison clinical efficiency with IPFI patients who treated
      by different protocols(empirical therapy or preemptive therapy) in ICU.
a multicenter study ( a total of 2411 person-time ) found In the United States in 205,
      antifungal therapy in empirical therapy, preemptive therapy, target therapy of respectively
      44%, 43%, 12%. While the existing on preemptive therapy and empiric treatment comparative
      study shows, the survival rate of the patients without differences, cost and application of
      antifungal drugs are relatively more in empirical therapy. These findings of differences, is
      due to the different research forecast model, treatment options vary widely, and are without
      a prospective multicenter study of verification. Initiation of antifungal therapy time and
      antifungal drug of choice is affected by many factors, including the risk stratification of
      patients, clinical manifestations, bacterial infection of evidence and non interventional
      diagnosis method results. How to grasp the opportunity to treat the fungal infections by
      empirical therapy or preemptive therapy that has plagued the global clinical doctors. The
      purpose of this study is aimed at the large scale prospective, multicenter study method to
      China, severe invasive pulmonary fungal infection of the empiric treatment with preemptive
      therapy for clinical contrast research, exploration of fungal treatment time and plan, to
      establish China's own optimal antifungal treatment options, are reduced in patients with
      severe fungal infection harm and increase the rate of successful treatment with
      evidence-based medical evidence.
observational model: Case-Control
time perspective: Prospective
arm group label: empirical therapy
description: immediate initiation of antifungal therapy; Itraconazole :1-14day,iv；(400mg/day bid 1-2day, 200mg/day q.d 3-14day) 15-28day,p.o(400mg/day bid)
arm group label: preemptive therapy
description: Dynamic monitoring of fungal infection, initiation antifungal therapy when clinical diagnosis ( microbial + experiment +, G/GM, CT typical change ) approveled in two weeks Itraconazole :1-14day,iv；(400mg/day bid 1-2day, 200mg/day q.d 3-14day) 15-28day,p.o(400mg/day bid) If within two weeks without obtaining positive results, researchers determine whether initiation of antifungal therapy。
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: yan kang, director
role: Principal Investigator
affiliation: West China Hospital
last name: xiao bo huang, director
role: Study Director
affiliation: Sichuan Provincial People's Hospital
last name: chuan zhang, director
role: Study Director
affiliation: Third people's Hospital of Chengdu City
last name: di-fen wang, director
role: Study Director
affiliation: Affiliated Hospital of Guiyang Medical College
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: West China Hospital
investigator full name: yan kang
investigator title: director（ICU）
mesh term: Mycoses
mesh term: Lung Diseases, Fungal