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Clinical Study of Anerning Particle for the Treatment of Childhood Community-acquired Pneumonia

Primary Purpose

Community-acquired Pneumonia

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Anerning particle
control group
Sponsored by
China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring Anerning particle, Clinical endpoint antibiotic application frequency, efficacy and safety, randomized, double blind

Eligibility Criteria

1 Year - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Meet the diagnostic criteria for children's CAP Western medicine and consider bacterial infection;
  2. Those who meet the diagnostic criteria of TCM syndrome differentiation of wind-heat and closed lung syndrome;
  3. Children aged 1 to 5 years old;
  4. Within 48 hours of onset of CAP;
  5. The informed consent process is in compliance with the regulations, and the legal representative signs the informed consent form.

Exclusion Criteria:

  1. Chest X-ray films showed obvious lung tumors and tuberculosis;
  2. Those with acute infectious diseases such as measles, whooping cough, and influenza;
  3. Other upper respiratory tract infections, wheezing-like bronchitis, bronchial asthma, bronchial foreign bodies and other respiratory diseases;
  4. Children with severe malnutrition and immunodeficiency;
  5. Combine severe primary diseases such as severe heart, liver, kidney, digestion and hematopoietic system;
  6. Those who meet the CAP (severe) Western diagnostic criteria for children;
  7. Clinically diagnosed or clinically considered viral pneumonia, Mycoplasma pneumoniae pneumonia;
  8. allergic constitution (allergic to more than 2 types of substances), or allergic to penicillins, cephalosporin antibiotics and Anering granules and their components;
  9. Researchers believe that it is not appropriate to join the group.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    treatment group

    control group

    Arm Description

    Anerning particle +ceftriaxone sodium

    Anerning particle placebo+ceftriaxone sodium

    Outcomes

    Primary Outcome Measures

    Whether Anerning particle can reduce the use of antibiotics
    Frequency of antibiotics (DDDs) at clinical endpoints of the two groups

    Secondary Outcome Measures

    The chest X-ray of 216 participants will be assessed.
    If the chest radiograph returns to normal, it indicates that the patient has recovered.
    The blood routine and c-reactive protein of 216 participants will be assessed.
    Combined detection of c-reactive protein and white blood cell， if the two indicators return to normal after treatment, the child recovers.
    Complete fever time
    Judging criteria: body temperature (underarm temperature) <37.3 ° C, and maintained for 24h and above. Measurement method: measured every 8h.

    Full Information

    First Posted
    August 5, 2018
    Last Updated
    September 16, 2018
    Sponsor
    China Academy of Chinese Medical Sciences
    Collaborators
    The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03675178
    Brief Title
    Clinical Study of Anerning Particle for the Treatment of Childhood Community-acquired Pneumonia
    Official Title
    Anerning Particle for Reducing the Application of Antibiotics of Childhood Community-acquired Pneumonia: a Randomized, Double Blind, Control of Placebo, Multi-center Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 22, 2018 (Anticipated)
    Primary Completion Date
    June 30, 2019 (Anticipated)
    Study Completion Date
    December 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    China Academy of Chinese Medical Sciences
    Collaborators
    The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the efficacy, safety and whether it can reduction of antibiotic use in the treatment of community-acquired pneumonia in children with Anerning granules combined with ceftriaxone sodium.
    Detailed Description
    To evaluate the efficacy, safety and whether it can reduction of antibiotic use in the treatment of community-acquired pneumonia in children with Anerning granules combined with ceftriaxone sodium.In this study, a randomized, double blind, parallel control of placebo, multi-center clinical study will be established. According to the relevant regulations of the CFDA, 216 cases need to be registered at least.The aim population is children who suffering of community-acquired pneumonia from September 2018 to December 2019. These cases will be devided into treatment group（Anerning particle+ Intravenous ceftriaxone sodium）,control group（Anerning particle simulants+ Intravenous ceftriaxone sodium）. Each group will be treated for 10 days hospitalization and if there is adverse drug reaction during treatment, follow-up until the laboratory indicators are normal. The efficacy indicators of this study were mainly from three dimensions: Frequency of antibiotics at the clinical endpoint, Total disease efficiency, Clinical recovery time. The symptom scores changes of each group before and after treatment were observed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Community-acquired Pneumonia
    Keywords
    Anerning particle, Clinical endpoint antibiotic application frequency, efficacy and safety, randomized, double blind

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    216 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    treatment group
    Arm Type
    Experimental
    Arm Description
    Anerning particle +ceftriaxone sodium
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm Description
    Anerning particle placebo+ceftriaxone sodium
    Intervention Type
    Drug
    Intervention Name(s)
    Anerning particle
    Other Intervention Name(s)
    ceftriaxone sodium
    Intervention Description
    Anerning particle ,1 bag/time,3 times/ day, +ceftriaxone sodium,50mg/kg/time, 1 time/day, the total amount per day does not exceed 2g，for 10 days.When the condition is cured, stop the medicine at any time.
    Intervention Type
    Drug
    Intervention Name(s)
    control group
    Other Intervention Name(s)
    Anerning particle placebo
    Intervention Description
    Anerning particle placebo ,1 bag/time,3 times/ day, +ceftriaxone sodium,50mg/kg/time, 1 time/day, the total amount per day does not exceed 2g，for 10 days.When the condition is cured, stop the medicine at any time.
    Primary Outcome Measure Information:
    Title
    Whether Anerning particle can reduce the use of antibiotics
    Description
    Frequency of antibiotics (DDDs) at clinical endpoints of the two groups
    Time Frame
    After 10 days of medication.When the condition is cured, stop the medicine at any time.
    Secondary Outcome Measure Information:
    Title
    The chest X-ray of 216 participants will be assessed.
    Description
    If the chest radiograph returns to normal, it indicates that the patient has recovered.
    Time Frame
    The maximum time for administration according to the protocol is 10 days, and the drug can be stopped at any time during clinical cure. If it is not good to change on the 6th day of treatment, use other measures.
    Title
    The blood routine and c-reactive protein of 216 participants will be assessed.
    Description
    Combined detection of c-reactive protein and white blood cell， if the two indicators return to normal after treatment, the child recovers.
    Time Frame
    The maximum time for administration according to the protocol is 10 days, and the drug can be stopped at any time during clinical cure. If it is not good to change on the 6th day of treatment, use other measures.
    Title
    Complete fever time
    Description
    Judging criteria: body temperature (underarm temperature) <37.3 ° C, and maintained for 24h and above. Measurement method: measured every 8h.
    Time Frame
    The maximum time for administration according to the protocol is 10 days, and the drug can be stopped at any time during clinical cure. If it is not good to change on the 6th day of treatment, use other measures.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Meet the diagnostic criteria for children's CAP Western medicine and consider bacterial infection; Those who meet the diagnostic criteria of TCM syndrome differentiation of wind-heat and closed lung syndrome; Children aged 1 to 5 years old; Within 48 hours of onset of CAP; The informed consent process is in compliance with the regulations, and the legal representative signs the informed consent form. Exclusion Criteria: Chest X-ray films showed obvious lung tumors and tuberculosis; Those with acute infectious diseases such as measles, whooping cough, and influenza; Other upper respiratory tract infections, wheezing-like bronchitis, bronchial asthma, bronchial foreign bodies and other respiratory diseases; Children with severe malnutrition and immunodeficiency; Combine severe primary diseases such as severe heart, liver, kidney, digestion and hematopoietic system; Those who meet the CAP (severe) Western diagnostic criteria for children; Clinically diagnosed or clinically considered viral pneumonia, Mycoplasma pneumoniae pneumonia; allergic constitution (allergic to more than 2 types of substances), or allergic to penicillins, cephalosporin antibiotics and Anering granules and their components; Researchers believe that it is not appropriate to join the group.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yanming Xie, BA
    Phone
    86-13911112416
    Email
    ktzu2018@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lianxin Wang, Doctor
    Phone
    86-13521781839
    Email
    wlxing@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yanming Xie, BA
    Organizational Affiliation
    Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Clinical Study of Anerning Particle for the Treatment of Childhood Community-acquired Pneumonia

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