<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/NCT04479657</url>
  </required_header>
  <id_info>
    <org_study_id>QFKL V3.0</org_study_id>
    <nct_id>NCT04479657</nct_id>
  </id_info>
  <brief_title>Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection</brief_title>
  <official_title>A Randomized Controlled Study of Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhong Wang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Academy of Chinese Medical Sciences</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>
      The study aims to assess the antibacterial effect and symptoms-relief of Qingfei Granule in&#xD;
      the patients with pediatric acute upper respiratory tract infection with bacterial infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Upper respiratory tract infection is the most common respiratory disease in childhood, and&#xD;
      the incidence rate accounts for more than 60% of pediatric outpatients, ranking first in&#xD;
      pediatric diseases. At present, antibiotics are commonly used to treat children with upper&#xD;
      respiratory tract infections. However, due to the large amount of clinical use of antibiotics&#xD;
      in recent years, the resistance of various pathogens has become stronger and stronger, which&#xD;
      has caused the majority of clinicians and researchers to turn their attention to traditional&#xD;
      Chinese medicine. Qingfei Granule is composed of six common herbal medicines such as&#xD;
      Schizonepeta (Jing-Jie),Radix Scutellariae (Huang-qin),Forsythia (Lian-Qiao), etc. After&#xD;
      upper respiratory tract infections with bacterial infections, chills, fever, runny nose, red&#xD;
      and sore throat may occur, and may be accompanied by mild cough, thin red tongue, yellow&#xD;
      moss, floating pulse,which is considered as the exogenous wind-heat Zheng in Chinese&#xD;
      medicine. The study aims to assess the antibacterial effect and symptoms-relief of Qingfei&#xD;
      Granule in the patients with pediatric acute upper respiratory tract infection with bacterial&#xD;
      infection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 17, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bacterial clearance</measure>
    <time_frame>0, Day 5</time_frame>
    <description>The pharyngeal swabs were used for sampling, and the pharyngeal flora diversity amplicon sequencing was used to analyze the pharyngeal flora spectrum, and the change of pathogenic bacteria flora spectrum before and after treatment was analyzed to qualitatively judge the bacterial clearance.&#xD;
Calculate the bacterial clearance rate = (number of people removed / total number of people tested) × 100%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical remission rate of disease</measure>
    <time_frame>Day 3,Day 5</time_frame>
    <description>The clinical remission rate of disease is defined as: the main symptoms such as chills, fever, nasal congestion, runny nose, sore throat, cough, etc. alleviate or disappear. Upper respiratory tract infection symptom scale score decreased by more than 70% compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fever clearance time</measure>
    <time_frame>Up to Day 5</time_frame>
    <description>record once every 4 to 8 h after treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment failure rate</measure>
    <time_frame>Up to Day 5</time_frame>
    <description>Treatment failure is defined as: body temperature does not decrease for 3 consecutive days, and / or complicated by laryngitis, tracheobronchitis, pneumonia, myocarditis, and / or oral antibiotics are switched to intravenous antibiotics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of the complications</measure>
    <time_frame>Up to Day 5</time_frame>
    <description>complicated with laryngitis, tracheo-bronchitis, pneumonia, myocarditis and other complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The usage of the ibuprofen</measure>
    <time_frame>Up to Day 5</time_frame>
    <description>If the temperature is over 38.5℃ or the child feel unbearable discomfort, the child will be given with ibuprofen. The usage of the ibuprofen (including the usage times and detail amount will be recorded in the patients' dairy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The usage of antibiotics (Cefuroxime)</measure>
    <time_frame>Up to Day 5</time_frame>
    <description>The usage of Cefuroxime (including the usage times and detail amount will be recorded in the patients' dairy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The normalization rate of the blood routine</measure>
    <time_frame>Day 3, Day 5</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Upper Respiratory Tract Infection</condition>
  <condition>Bacterial Infection</condition>
  <condition>Chinese Medicine</condition>
  <condition>Pediatric Acute Upper Respiratory Tract Infection</condition>
  <arm_group>
    <arm_group_label>QingFei Granule+Cefuroxime group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cefuroxime：30mg/kg/d,bid QingFei Granule: tid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cefuroxime group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cefuroxime：30mg/kg/d,bid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>QingFei Granule</intervention_name>
    <description>QingFei Granule is made from 6 commonly herbal medicine granule, such as Jingjie,Huang Qin,Lianqiao,etc. The children were given one package of QingFei Granule every day, dividing into 3 times to be administrated. It's be given for 5 days.</description>
    <arm_group_label>QingFei Granule+Cefuroxime group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cefuroxime</intervention_name>
    <description>30mg/kg/d,bid, used until to the normalization of blood routine。</description>
    <arm_group_label>Cefuroxime group</arm_group_label>
    <arm_group_label>QingFei Granule+Cefuroxime group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis with the acute upper respiratory tract infection;&#xD;
&#xD;
          2. Diagnosis with wind-heat Zheng according to Chinese medicine;&#xD;
&#xD;
          3. Age: 5-14 years old;&#xD;
&#xD;
          4. Body temperature ≥ 37.5 ℃;&#xD;
&#xD;
          5. White blood cell count&gt; 12 × 10^9 / L, and / or neutrophil ratio over than 70%;&#xD;
&#xD;
          6. The informed consent process complies with the regulations, and the legal agent or the&#xD;
             child (≥8 years old) jointly sign the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (1) Acute bacterial otitis media; (2) Patients with periodontitis or periodontal abscess&#xD;
        (3) Candidiasis; (4) Patients with positive mycoplasma; (5) Taking antibiotics,&#xD;
        anti-inflammatory drugs, and antihistamines; (6) Patients with severe comorbidities of&#xD;
        heart, liver and kidney; (7) Other patients with acute infectious diseases and mycoplasma&#xD;
        pneumoniae infections with symptoms similar to upper respiratory tract infection; (8)&#xD;
        Children with a history of epilepsy or convulsions; (9) Patients with mental illness; (10)&#xD;
        Those who are allergic to treatment drugs; (11) Participated in other clinical trials in&#xD;
        the past month; (12) The investigator evaluates that it is not suitable to participate in&#xD;
        this clinical trial or according to the investigator's judgment, who is likely to loss to&#xD;
        follow-up.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jun Liu</last_name>
    <phone>8610-64093207</phone>
    <email>franlj1104@aliyun.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dongfang Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100078</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li-Qun Wu, Prof.</last_name>
      <phone>010-67689706</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>November 14, 2022</last_update_submitted>
  <last_update_submitted_qc>November 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>China Academy of Chinese Medical Sciences</investigator_affiliation>
    <investigator_full_name>Zhong Wang</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>Respiratory Tract Infections</mesh_term>
    <mesh_term>Bacterial Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cefuroxime</mesh_term>
    <mesh_term>Cefuroxime axetil</mesh_term>
  </intervention_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/NCT04479657
org study id: QFKL V3.0
nct id: NCT04479657
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aims to assess the antibacterial effect and symptoms-relief of Qingfei Granule in
      the patients with pediatric acute upper respiratory tract infection with bacterial infection.
Upper respiratory tract infection is the most common respiratory disease in childhood, and
      the incidence rate accounts for more than 60% of pediatric outpatients, ranking first in
      pediatric diseases. At present, antibiotics are commonly used to treat children with upper
      respiratory tract infections. However, due to the large amount of clinical use of antibiotics
      in recent years, the resistance of various pathogens has become stronger and stronger, which
      has caused the majority of clinicians and researchers to turn their attention to traditional
      Chinese medicine. Qingfei Granule is composed of six common herbal medicines such as
      Schizonepeta (Jing-Jie),Radix Scutellariae (Huang-qin),Forsythia (Lian-Qiao), etc. After
      upper respiratory tract infections with bacterial infections, chills, fever, runny nose, red
      and sore throat may occur, and may be accompanied by mild cough, thin red tongue, yellow
      moss, floating pulse,which is considered as the exogenous wind-heat Zheng in Chinese
      medicine. The study aims to assess the antibacterial effect and symptoms-relief of Qingfei
      Granule in the patients with pediatric acute upper respiratory tract infection with bacterial
      infection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Bacterial clearance
time frame: 0, Day 5
description: The pharyngeal swabs were used for sampling, and the pharyngeal flora diversity amplicon sequencing was used to analyze the pharyngeal flora spectrum, and the change of pathogenic bacteria flora spectrum before and after treatment was analyzed to qualitatively judge the bacterial clearance.
Calculate the bacterial clearance rate = (number of people removed / total number of people tested) × 100%
measure: Clinical remission rate of disease
time frame: Day 3,Day 5
description: The clinical remission rate of disease is defined as: the main symptoms such as chills, fever, nasal congestion, runny nose, sore throat, cough, etc. alleviate or disappear. Upper respiratory tract infection symptom scale score decreased by more than 70% compared with baseline
measure: Fever clearance time
time frame: Up to Day 5
description: record once every 4 to 8 h after treatment.
measure: Treatment failure rate
time frame: Up to Day 5
description: Treatment failure is defined as: body temperature does not decrease for 3 consecutive days, and / or complicated by laryngitis, tracheobronchitis, pneumonia, myocarditis, and / or oral antibiotics are switched to intravenous antibiotics.
measure: The incidence of the complications
time frame: Up to Day 5
description: complicated with laryngitis, tracheo-bronchitis, pneumonia, myocarditis and other complications
measure: The usage of the ibuprofen
time frame: Up to Day 5
description: If the temperature is over 38.5℃ or the child feel unbearable discomfort, the child will be given with ibuprofen. The usage of the ibuprofen (including the usage times and detail amount will be recorded in the patients' dairy.
measure: The usage of antibiotics (Cefuroxime)
time frame: Up to Day 5
description: The usage of Cefuroxime (including the usage times and detail amount will be recorded in the patients' dairy.
measure: The normalization rate of the blood routine
time frame: Day 3, Day 5
arm group label: QingFei Granule+Cefuroxime group
arm group type: Experimental
description: Cefuroxime：30mg/kg/d,bid QingFei Granule: tid
arm group label: Cefuroxime group
arm group type: Active Comparator
description: Cefuroxime：30mg/kg/d,bid
intervention type: Drug
intervention name: QingFei Granule
description: QingFei Granule is made from 6 commonly herbal medicine granule, such as Jingjie,Huang Qin,Lianqiao,etc. The children were given one package of QingFei Granule every day, dividing into 3 times to be administrated. It's be given for 5 days.
arm group label: QingFei Granule+Cefuroxime group
intervention type: Drug
intervention name: Cefuroxime
description: 30mg/kg/d,bid, used until to the normalization of blood routine。
arm group label: Cefuroxime group
arm group label: QingFei Granule+Cefuroxime group
criteria: 
gender: All
minimum age: 5 Years
maximum age: 14 Years
healthy volunteers: No
last name: Jun Liu
phone: 8610-64093207
email: franlj1104@aliyun.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: China Academy of Chinese Medical Sciences
investigator full name: Zhong Wang
investigator title: Professor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Respiratory Tract Infections
mesh term: Bacterial Infections
mesh term: Cefuroxime
mesh term: Cefuroxime axetil