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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675178
Recruitment Status : Not yet recruiting
First Posted : September 18, 2018
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia Drug: Anerning particle Drug: control group Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 22, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: treatment group
Anerning particle +ceftriaxone sodium
Drug: Anerning particle
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.
Other Name: ceftriaxone sodium

Placebo Comparator: control group
Anerning particle placebo+ceftriaxone sodium
Drug: control group
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.
Other Name: Anerning particle placebo




Primary Outcome Measures :
  1. Whether Anerning particle can reduce the use of antibiotics [ Time Frame: After 10 days of medication.When the condition is cured, stop the medicine at any time. ]
    Frequency of antibiotics (DDDs) at clinical endpoints of the two groups


Secondary Outcome Measures :
  1. The chest X-ray of 216 participants will be assessed. [ 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. ]
    If the chest radiograph returns to normal, it indicates that the patient has recovered.

  2. The blood routine and c-reactive protein of 216 participants will be assessed. [ 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. ]
    Combined detection of c-reactive protein and white blood cell, if the two indicators return to normal after treatment, the child recovers.

  3. Complete fever time [ 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. ]
    Judging criteria: body temperature (underarm temperature) <37.3 ° C, and maintained for 24h and above. Measurement method: measured every 8h.



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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675178


Contacts
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Contact: Yanming Xie, BA 86-13911112416 ktzu2018@163.com
Contact: Lianxin Wang, Doctor 86-13521781839 wlxing@126.com

Sponsors and Collaborators
China Academy of Chinese Medical Sciences
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Investigators
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Principal Investigator: Yanming Xie, BA Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
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Responsible Party: Yanming Xie, Deputy director, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03675178    
Other Study ID Numbers: Anerning particle
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanming Xie, China Academy of Chinese Medical Sciences:
Anerning particle
Clinical endpoint antibiotic application frequency
efficacy and safety
randomized
double blind
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents