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

Phase 4

• Conditions: Community-acquired Pneumonia
• Interventions: Drug: Anerning particle; Drug: control group

• Registration Number: NCT03675178
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2018-08-05
• Status Verified: 2018-09
• Study First Submitted QC: 2018-09-16
• Last Update Submitted: 2018-09-16
• Study First Posted: 2018-09-18
• Last Update Posted: 2018-09-18
• Study Start: 2018-09-22
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 216

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	Anerning particle	Anerning particle +ceftriaxone sodium
control group	control group	Anerning particle placebo+ceftriaxone sodium

Primary Outcome Measures

Name	Time	Method
Whether Anerning particle can reduce the use of antibiotics	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

Name	Time	Method
The chest X-ray of 216 participants will be assessed.	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.
The blood routine and c-reactive protein of 216 participants will be assessed.	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.
Complete fever time	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.