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/NCT05988177</url>
    </required_header>
    <id_info>
      <org_study_id>BFH20230522002</org_study_id>
      <nct_id>NCT05988177</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Carrimycin Tablets in HLH Patients With Carbapenem-resistant Infections</brief_title>
    <official_title>Clinical Study on the Efficacy and Safety of Carrimycin Tablets in Hemophagocytic Lymphohistiocytosis Patients With Carbapenem-resistant Infections</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beijing Friendship Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beijing Friendship Hospital</source>
    <oversight_info>
      <has_dmc>No</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>
        This study aimed to investigate the efficacy and safety of Carrimycin tablets in&#xD;
        hemophagocytic lymphohistiocytosis patients with Carbapenem-resistant infections.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Hemophagocytic lymphohistiocytosis (HLH) is a critical condition characterized by the undue&#xD;
        activation of cytotoxic T lymphocytes, natural killer cells, and macrophages, resulting in&#xD;
        excessive secretion of infammatory cytokines. Infection is an important trigger for HLH. This&#xD;
        study aimed to investigate the efficacy and safety of Carrimycin tablets in hemophagocytic&#xD;
        lymphohistiocytosis patients with Carbapenem-resistant infections.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cure rates of infections</measure>
      <time_frame>1 week and 2 weeks after initiation of treatment</time_frame>
      <description>The percentage of participants having clinical cure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall response rate of HLH</measure>
      <time_frame>2 weeks after treatment</time_frame>
      <description>Overall response rate includes complete remission (CR) and partial remission (PR)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall Survival</measure>
      <time_frame>1 years</time_frame>
      <description>OS will be assessed from initiation of treatment to death from any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence and Severity of Adverse Events</measure>
      <time_frame>28 days</time_frame>
      <description>Treatment-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Carbapenem Resistant Bacterial Infection</condition>
    <condition>Hemophagocytic Lymphohistiocytoses</condition>
    <arm_group>
      <arm_group_label>Carrimycin tablets</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Carrimycin tablets</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Carrimycin tablets</intervention_name>
      <description>Carrimycin tablets are administered 400mg a day orally for 7 days.</description>
      <arm_group_label>Carrimycin tablets</arm_group_label>
      <other_name>Carrimycin</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Met HLH-2004 diagnostic criteria;&#xD;
  &#xD;
            -  Active infection；&#xD;
  &#xD;
            -  Empirical treatment with carbapenems did not respond after 72 hours；&#xD;
  &#xD;
            -  Age &gt;18 years old, no gender limitation;&#xD;
  &#xD;
            -  Ability and willingness to adhere to the study visit schedule and all protocol&#xD;
               requirements.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other antibiotics should be selected according to the results of drug sensitivity；&#xD;
  &#xD;
            -  Systemic antibiotics other than carbapenems are used with 72 hours；&#xD;
  &#xD;
            -  Inability to take oral medications due to disease of gastrointestinal tract；&#xD;
  &#xD;
            -  Severe liver insufficiency;&#xD;
  &#xD;
            -  Expected survival time &lt; 1 month;&#xD;
  &#xD;
            -  Pregnant or breasting-feeding women;&#xD;
  &#xD;
            -  Allergic to Carrimycin tablets;&#xD;
  &#xD;
            -  Active hepatitis B or hepatitis C infection;&#xD;
  &#xD;
            -  Patients with HIV infection;&#xD;
  &#xD;
            -  Patients with other contraindications considered unsuitable for participation in this&#xD;
               study.&#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>Zhao Wang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Beijing Friendship Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zhao Wang, MD</last_name>
      <phone>63138303</phone>
      <email>wangzhao@ccmu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beijing Friendship Hospital, Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100050</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Zhao Wang, MD</last_name>
        <phone>63138303</phone>
        <email>wangzhao@ccmu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beijing Friendship Hospital</investigator_affiliation>
      <investigator_full_name>Zhao Wang</investigator_full_name>
      <investigator_title>Professor and Head of hematology</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>Bacterial Infections</mesh_term>
      <mesh_term>Lymphohistiocytosis, Hemophagocytic</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spiramycin</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/NCT05988177
  org study id: BFH20230522002
  nct id: NCT05988177
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to investigate the efficacy and safety of Carrimycin tablets in
        hemophagocytic lymphohistiocytosis patients with Carbapenem-resistant infections.
  Hemophagocytic lymphohistiocytosis (HLH) is a critical condition characterized by the undue
        activation of cytotoxic T lymphocytes, natural killer cells, and macrophages, resulting in
        excessive secretion of infammatory cytokines. Infection is an important trigger for HLH. This
        study aimed to investigate the efficacy and safety of Carrimycin tablets in hemophagocytic
        lymphohistiocytosis patients with Carbapenem-resistant infections.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Cure rates of infections
  time frame: 1 week and 2 weeks after initiation of treatment
  description: The percentage of participants having clinical cure
  measure: Overall response rate of HLH
  time frame: 2 weeks after treatment
  description: Overall response rate includes complete remission (CR) and partial remission (PR)
  measure: Overall Survival
  time frame: 1 years
  description: OS will be assessed from initiation of treatment to death from any cause
  measure: Incidence and Severity of Adverse Events
  time frame: 28 days
  description: Treatment-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
  arm group label: Carrimycin tablets
  arm group type: Experimental
  description: Carrimycin tablets
  intervention type: Drug
  intervention name: Carrimycin tablets
  description: Carrimycin tablets are administered 400mg a day orally for 7 days.
  arm group label: Carrimycin tablets
  other name: Carrimycin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Zhao Wang, MD
  role: Principal Investigator
  affiliation: Beijing Friendship Hospital
  last name: Zhao Wang, MD
  phone: 63138303
  email: wangzhao@ccmu.edu.cn
  facility: 
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Beijing Friendship Hospital
  investigator full name: Zhao Wang
  investigator title: Professor and Head of hematology
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Bacterial Infections
  mesh term: Lymphohistiocytosis, Hemophagocytic
  mesh term: Spiramycin
  sharing ipd: No