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

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

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.

Study Overview

• Status: Unknown
• Conditions: Community-acquired Pneumonia
• Intervention / Treatment: Drug: Anerning particle; Drug: control group

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 Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Anerning particle placebo

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: China Academy of Chinese Medical Sciences
• Collaborators: The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): September 22, 2018
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: August 5, 2018
• First Submitted That Met QC Criteria: September 16, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 16, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: efficacy and safety; randomized; double blind; Anerning particle; Clinical endpoint antibiotic application frequency
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Anti-Infective Agents; Anti-Bacterial Agents; Ceftriaxone
• Other Study ID Numbers: Anerning particle

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No