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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Anerning Particle for Reducing the Application of Antibiotics of Childhood Community-acquired Pneumonia: a Randomized, Double Blind, Control of Placebo, Multi-center Clinical Study

Conditions
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Community-acquired Pneumonia

Intervention / Treatment
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* Drug: Anerning particle
* Drug: control group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>Anerning particle +ceftriaxone sodium | Drug: Anerning particle<br>* 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.<br>* Other names: ceftriaxone sodium;|
| Placebo Comparator: control group<br>Anerning particle placebo+ceftriaxone sodium | Drug: control group<br>* 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.<br>* Other names: Anerning particle placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether Anerning particle can reduce the use of antibiotics | Frequency of antibiotics (DDDs) at clinical endpoints of the two groups | After 10 days of medication.When the condition is cured, stop the medicine at any time. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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. | 
| 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. | 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. | 
| Complete fever time | Judging criteria: body temperature (underarm temperature) <37.3 ° C, and maintained for 24h and above. Measurement method: measured every 8h. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anerning particle, Clinical endpoint antibiotic application frequency, efficacy and safety, randomized, double blind