<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/NCT01684189</url>
  </required_header>
  <id_info>
    <org_study_id>MISP38887</org_study_id>
    <nct_id>NCT01684189</nct_id>
  </id_info>
  <brief_title>Registry of Febrile Neutropenia and Invasive Fungal Infections</brief_title>
  <official_title>A Non-interventional Prospective Registry to Monitor the Events of Febrile Neutropenia and Invasive Fungal Infections and the Diagnostic and Therapeutic Management in Patients With Malignant Hematologic Diseases After Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives：&#xD;
&#xD;
        1. To assess the percentage of febrile neutropenia and suspected fungal-related febrile&#xD;
           episodes in patients receiving chemotherapy&#xD;
&#xD;
        2. To explore the percentage/distribution of infectious origins of febrile neutropenia&#xD;
&#xD;
        3. To explore the percentage/distribution of infectious pathogens of febrile neutropenia&#xD;
&#xD;
        4. To explore clinical outcomes of different infectious origins/pathogens in febrile&#xD;
           neutropenia episodes&#xD;
&#xD;
        5. To have a clear view of therapeutic actions in the management of hematological patients&#xD;
           with febrile neutropenia and suspected fungal-related febrile episodes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives：&#xD;
&#xD;
        1. To assess the percentage of febrile neutropenia and suspected fungal-related febrile&#xD;
           episodes in patients receiving chemotherapy&#xD;
&#xD;
        2. To explore the percentage/distribution of infectious origins of febrile neutropenia&#xD;
&#xD;
        3. To explore the percentage/distribution of infectious pathogens of febrile neutropenia&#xD;
&#xD;
        4. To explore clinical outcomes of different infectious origins/pathogens in febrile&#xD;
           neutropenia episodes&#xD;
&#xD;
        5. To have a clear view of therapeutic actions in the management of hematological patients&#xD;
           with febrile neutropenia and suspected fungal-related febrile episodes&#xD;
&#xD;
      Study Design：&#xD;
&#xD;
        -  This is a single institute, prospective, non-interventional registry for monitoring&#xD;
           events of febrile neutropenia in hematological patients&#xD;
&#xD;
        -  Patients with newly diagnosed malignant hematological diseases will be enrolled into&#xD;
           this registry&#xD;
&#xD;
      Study Procedures： Data collection will include patients' basic information, underlying&#xD;
      disease, baseline blood chemistry and blood cell counts, antifungal prophylaxis, C/T&#xD;
      regimens, neutrophils and other blood cells, fever diagnosis and infectious sites work-up,&#xD;
      clinical response, microbiology (including bacteria and fungus culture), renal and liver&#xD;
      function, clinical diagnosis, work-up and intensive procedures and results, antifungal and&#xD;
      antibacterial agents (including dosage, duration, and route), other drugs used (including&#xD;
      antivirals, antineoplastics, corticosteroids, immunomodulators), clinical significant changes&#xD;
&#xD;
      Sample Size Calculation and Statistical Analysis： Approximately 100 febrile neutropenia&#xD;
      episodes in 500 chemotherapy cycles will be collected. This is an observational and&#xD;
      exploratory study without hypothesis tests. Study subjects will be collected and monitored&#xD;
      under normal clinical practice, and the sample size will be limited due to the hospital scale&#xD;
      and disease characteristic (the sample size calculation is inapplicable here). All&#xD;
      evaluations will be shown by exploratory and descriptive data analysis. The number of cases&#xD;
      for each investigative definition, the corresponding percentage and the 95% confidence&#xD;
      interval will be described.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2011</start_date>
  <completion_date type="Anticipated">August 2013</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hematological Disease</condition>
  <condition>Febrile Neutropenia</condition>
  <condition>Fungal Infections</condition>
  <arm_group>
    <arm_group_label>Patient registry</arm_group_label>
    <description>Patients with newly diagnosed malignant hematological diseases will be enrolled into this registry</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient registry</intervention_name>
    <description>Patient registry without study intervention</description>
    <arm_group_label>Patient registry</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with newly diagnosed malignant hematological diseases&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with new diagnosed hematological diseases (acute and chronic myeloid and&#xD;
             lymphoid leukemia, multiple myeloma, non-Hodgkin's and Hodgkin's lymphoma,&#xD;
             myelodysplastic syndromes)&#xD;
&#xD;
          -  Patients who are receiving chemotherapy and have ongoing febrile episodes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming-Chung Wang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ming-Chung Wang, M.D.</last_name>
    <phone>+886-7-7317123</phone>
    <phone_ext>3266</phone_ext>
    <email>wang9595@ms32.hinet.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ming-Chung Wang, M.D.</last_name>
      <phone>+886-7-7317123</phone>
      <phone_ext>3266</phone_ext>
      <email>wang9595@ms32.hinet.net</email>
    </contact>
    <investigator>
      <last_name>Ming-Chung Wang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2011</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>September 11, 2012</last_update_submitted>
  <last_update_submitted_qc>September 11, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Mycoses</mesh_term>
    <mesh_term>Invasive Fungal Infections</mesh_term>
    <mesh_term>Neutropenia</mesh_term>
    <mesh_term>Febrile Neutropenia</mesh_term>
    <mesh_term>Hematologic Diseases</mesh_term>
    <mesh_term>Hyperthermia</mesh_term>
    <mesh_term>Fever</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/NCT01684189
org study id: MISP38887
nct id: NCT01684189
lead sponsor: 
has dmc: No
Objectives：

        1. To assess the percentage of febrile neutropenia and suspected fungal-related febrile
           episodes in patients receiving chemotherapy

        2. To explore the percentage/distribution of infectious origins of febrile neutropenia

        3. To explore the percentage/distribution of infectious pathogens of febrile neutropenia

        4. To explore clinical outcomes of different infectious origins/pathogens in febrile
           neutropenia episodes

        5. To have a clear view of therapeutic actions in the management of hematological patients
           with febrile neutropenia and suspected fungal-related febrile episodes
Objectives：

        1. To assess the percentage of febrile neutropenia and suspected fungal-related febrile
           episodes in patients receiving chemotherapy

        2. To explore the percentage/distribution of infectious origins of febrile neutropenia

        3. To explore the percentage/distribution of infectious pathogens of febrile neutropenia

        4. To explore clinical outcomes of different infectious origins/pathogens in febrile
           neutropenia episodes

        5. To have a clear view of therapeutic actions in the management of hematological patients
           with febrile neutropenia and suspected fungal-related febrile episodes

      Study Design：

        -  This is a single institute, prospective, non-interventional registry for monitoring
           events of febrile neutropenia in hematological patients

        -  Patients with newly diagnosed malignant hematological diseases will be enrolled into
           this registry

      Study Procedures： Data collection will include patients' basic information, underlying
      disease, baseline blood chemistry and blood cell counts, antifungal prophylaxis, C/T
      regimens, neutrophils and other blood cells, fever diagnosis and infectious sites work-up,
      clinical response, microbiology (including bacteria and fungus culture), renal and liver
      function, clinical diagnosis, work-up and intensive procedures and results, antifungal and
      antibacterial agents (including dosage, duration, and route), other drugs used (including
      antivirals, antineoplastics, corticosteroids, immunomodulators), clinical significant changes

      Sample Size Calculation and Statistical Analysis： Approximately 100 febrile neutropenia
      episodes in 500 chemotherapy cycles will be collected. This is an observational and
      exploratory study without hypothesis tests. Study subjects will be collected and monitored
      under normal clinical practice, and the sample size will be limited due to the hospital scale
      and disease characteristic (the sample size calculation is inapplicable here). All
      evaluations will be shown by exploratory and descriptive data analysis. The number of cases
      for each investigative definition, the corresponding percentage and the 95% confidence
      interval will be described.
observational model: Case-Only
time perspective: Prospective
arm group label: Patient registry
description: Patients with newly diagnosed malignant hematological diseases will be enrolled into this registry
intervention type: Other
intervention name: Patient registry
description: Patient registry without study intervention
arm group label: Patient registry
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ming-Chung Wang, M.D.
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
last name: Ming-Chung Wang, M.D.
phone: +886-7-7317123
phone ext: 3266
email: wang9595@ms32.hinet.net
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Mycoses
mesh term: Invasive Fungal Infections
mesh term: Neutropenia
mesh term: Febrile Neutropenia
mesh term: Hematologic Diseases
mesh term: Hyperthermia
mesh term: Fever