<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/NCT03819348</url>
  </required_header>
  <id_info>
    <org_study_id>RA-TSM-HIVN-ECDP</org_study_id>
    <nct_id>NCT03819348</nct_id>
  </id_info>
  <brief_title>Retrospective Analysis of the Epidemiological Change and Determinants of Prognosis of Talaromycosisof Human Immunodeficiency Virus Negative Host in Guangxi</brief_title>
  <acronym>RAECDPT</acronym>
  <official_title>The First Affiliated Hospital of Guangxi Medical University</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangxi Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Second Affiliated Hospital of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Fourth People's Hospital of Nanning</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guilin Medical College</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nanning Second People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>People's Hospital of Guangxi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guangxi Medical University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Through a multi-center large-sample retrospective study, the epidemiological changes of TSM&#xD;
      in Guangxi have been reviewed, its incidence trend was understood to attract the attention of&#xD;
      clinicians; the multiple programs of antifungal therapy for HIV-negative host TSM were&#xD;
      compared in terms of effect on clinical remission rate, effective rate, recurrence rate,&#xD;
      mortality and toxic side effects on HIV-negative host TSM; their prognosis and recurrence&#xD;
      indicators were clarified, and a therapeutic effect evaluation system was established,&#xD;
      providing a standard treatment and diagnosis scheme for clinical practice; and simultaneously&#xD;
      the positive rate of G and GM experiments in respect of TSM, Aspergillus and other fungi was&#xD;
      identified to provide TSM with biological diagnostic indicators. Improve the level of&#xD;
      understanding and diagnosis and treatment of HIV-negative TSM in the whole area. A&#xD;
      comprehensive efficacy evaluation system and standard treatment program was established to&#xD;
      provide a basis for standardized treatment of TSM in HIV-negative hosts. The observational&#xD;
      indicators included: 2-week all-cause mortality; 24-week all-cause mortality; clinical&#xD;
      improvement time; level of decrease of fungus in the blood culture medium two weeks before&#xD;
      treatment; recurrence; appearance of adverse drug reaction at the level 3 and above.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2003</start_date>
  <completion_date type="Anticipated">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</primary_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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>clinical remission rate</measure>
    <time_frame>7 days</time_frame>
    <description>Clinical resolution of talaromycosis was defined as a temperature of less than 38°C (100°F) for 3 days, resolution of skin lesions, and sterile blood cultures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>recurrence rate</measure>
    <time_frame>12 months</time_frame>
    <description>Relapse of talaromycosis was defined as the recurrence of symptoms and a positive fungal culture from any sterile site that led to reinduction of therapy in patients who had achieved clinical resolution.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mortality at 4 week</measure>
    <time_frame>4 weeks</time_frame>
    <description>all-cause mortality was defined as the absolute risk of death from any cause during the first 2 weeks after randomization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>toxic side effects</measure>
    <time_frame>24 weeks</time_frame>
    <description>Side effects were monitored clinically and with the use of hematologic, chemical, and liver-enzyme testing performed at least twice weekly</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mortality at week 24</measure>
    <time_frame>24 weeks</time_frame>
    <description>The secondary outcome measures were mortality at week 24, the time to clinical resolution of talaromycosis, early fungicidal activity, relapse of talaromycosis, and the incidence of adverse events of grade 3 or higher.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>G test</measure>
    <time_frame>3 days</time_frame>
    <description>positive was defined as &gt;20pg/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GM test</measure>
    <time_frame>3 days</time_frame>
    <description>positive was defined as &gt;0.5</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1200</enrollment>
  <condition>To Investigate the Characteristics and Prognostic Factors of T. Marneffei Infections and the Causes of Misdiagnosis</condition>
  <condition>To Study the Recurrence Indicators and Establish a Therapeutic Effect Evaluation System of T. Marneffei Infections</condition>
  <arm_group>
    <arm_group_label>TSM of HIV-negative Host</arm_group_label>
    <description>Eligible patients were HIV-infected adults who had talaromycosis that was confirmed by either microscopy or culture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>the multiple programs of antifungal therapy for HIV-negative host</intervention_name>
    <description>the multiple programs of antifungal therapy for HIV-negative host TSM were compared in terms of effect on clinical remission rate, effective rate, recurrence rate, mortality and toxic side effects on HIV-negative host TSM; their prognosis and recurrence indicators were clarified, and a therapeutic effect evaluation system was established, providing a standard treatment and diagnosis scheme for clinical practice; and simultaneously the positive rate of G and GM experiments in respect of TSM, Aspergillus and other fungi was identified to provide TSM with biological diagnostic indicators.</description>
    <arm_group_label>TSM of HIV-negative Host</arm_group_label>
    <other_name>their prognosis and recurrence</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We studied the clinical characteristics and prognoses of patients with infections due to&#xD;
        Talaromyces marneffei who were admitted to Guangxi Hospital, This province is located in&#xD;
        subtropical southern China, where Talaromyces marneffei is endemic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible patients were HIV-negative adults who had talaromycosis that was confirmed by&#xD;
             either microscopy or culture.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients were HIV-infected adults who had talaromycosis that was confirmed by either&#xD;
             microscopy or culture.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Guangxi Medical University</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/28614691</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <citation>Le T, Kinh NV, Cuc NTK, Tung NLN, Lam NT, Thuy PTT, Cuong DD, Phuc PTH, Vinh VH, Hanh DTH, Tam VV, Thanh NT, Thuy TP, Hang NT, Long HB, Nhan HT, Wertheim HFL, Merson L, Shikuma C, Day JN, Chau NVV, Farrar J, Thwaites G, Wolbers M; IVAP Investigators. A Trial of Itraconazole or Amphotericin B for HIV-Associated Talaromycosis. N Engl J Med. 2017 Jun 15;376(24):2329-2340. doi: 10.1056/NEJMoa1613306.</citation>
    <PMID>28614691</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangxi Medical University</investigator_affiliation>
    <investigator_full_name>Qiu Ye</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </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>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antifungal Agents</mesh_term>
    <mesh_term>Clotrimazole</mesh_term>
    <mesh_term>Miconazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>http://oldweb.gxmuyfy.cn/gxmufy1/1fy/browse/browse6.asp?id=10080</doc_url>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03819348
org study id: RA-TSM-HIVN-ECDP
nct id: NCT03819348
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Through a multi-center large-sample retrospective study, the epidemiological changes of TSM
      in Guangxi have been reviewed, its incidence trend was understood to attract the attention of
      clinicians; the multiple programs of antifungal therapy for HIV-negative host TSM were
      compared in terms of effect on clinical remission rate, effective rate, recurrence rate,
      mortality and toxic side effects on HIV-negative host TSM; their prognosis and recurrence
      indicators were clarified, and a therapeutic effect evaluation system was established,
      providing a standard treatment and diagnosis scheme for clinical practice; and simultaneously
      the positive rate of G and GM experiments in respect of TSM, Aspergillus and other fungi was
      identified to provide TSM with biological diagnostic indicators. Improve the level of
      understanding and diagnosis and treatment of HIV-negative TSM in the whole area. A
      comprehensive efficacy evaluation system and standard treatment program was established to
      provide a basis for standardized treatment of TSM in HIV-negative hosts. The observational
      indicators included: 2-week all-cause mortality; 24-week all-cause mortality; clinical
      improvement time; level of decrease of fungus in the blood culture medium two weeks before
      treatment; recurrence; appearance of adverse drug reaction at the level 3 and above.
observational model: Case-Only
time perspective: Retrospective
measure: clinical remission rate
time frame: 7 days
description: Clinical resolution of talaromycosis was defined as a temperature of less than 38°C (100°F) for 3 days, resolution of skin lesions, and sterile blood cultures.
measure: recurrence rate
time frame: 12 months
description: Relapse of talaromycosis was defined as the recurrence of symptoms and a positive fungal culture from any sterile site that led to reinduction of therapy in patients who had achieved clinical resolution.
measure: mortality at 4 week
time frame: 4 weeks
description: all-cause mortality was defined as the absolute risk of death from any cause during the first 2 weeks after randomization.
measure: toxic side effects
time frame: 24 weeks
description: Side effects were monitored clinically and with the use of hematologic, chemical, and liver-enzyme testing performed at least twice weekly
measure: mortality at week 24
time frame: 24 weeks
description: The secondary outcome measures were mortality at week 24, the time to clinical resolution of talaromycosis, early fungicidal activity, relapse of talaromycosis, and the incidence of adverse events of grade 3 or higher.
measure: G test
time frame: 3 days
description: positive was defined as >20pg/ml
measure: GM test
time frame: 3 days
description: positive was defined as >0.5
arm group label: TSM of HIV-negative Host
description: Eligible patients were HIV-infected adults who had talaromycosis that was confirmed by either microscopy or culture.
intervention type: Other
intervention name: the multiple programs of antifungal therapy for HIV-negative host
description: the multiple programs of antifungal therapy for HIV-negative host TSM were compared in terms of effect on clinical remission rate, effective rate, recurrence rate, mortality and toxic side effects on HIV-negative host TSM; their prognosis and recurrence indicators were clarified, and a therapeutic effect evaluation system was established, providing a standard treatment and diagnosis scheme for clinical practice; and simultaneously the positive rate of G and GM experiments in respect of TSM, Aspergillus and other fungi was identified to provide TSM with biological diagnostic indicators.
arm group label: TSM of HIV-negative Host
other name: their prognosis and recurrence
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: China
url: https://www.ncbi.nlm.nih.gov/pubmed/28614691
description: Related Info
citation: Le T, Kinh NV, Cuc NTK, Tung NLN, Lam NT, Thuy PTT, Cuong DD, Phuc PTH, Vinh VH, Hanh DTH, Tam VV, Thanh NT, Thuy TP, Hang NT, Long HB, Nhan HT, Wertheim HFL, Merson L, Shikuma C, Day JN, Chau NVV, Farrar J, Thwaites G, Wolbers M; IVAP Investigators. A Trial of Itraconazole or Amphotericin B for HIV-Associated Talaromycosis. N Engl J Med. 2017 Jun 15;376(24):2329-2340. doi: 10.1056/NEJMoa1613306.
PMID: 28614691
responsible party type: Principal Investigator
investigator affiliation: Guangxi Medical University
investigator full name: Qiu Ye
investigator title: Professor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Recurrence
mesh term: Antifungal Agents
mesh term: Clotrimazole
mesh term: Miconazole
sharing ipd: No
study doc: 