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
1 other identifier
interventional
216
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2018
CompletedFirst Posted
Study publicly available on registry
September 18, 2018
CompletedStudy Start
First participant enrolled
September 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedSeptember 18, 2018
September 1, 2018
9 months
August 5, 2018
September 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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.
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.
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.
Study Arms (2)
treatment group
EXPERIMENTALAnerning particle +ceftriaxone sodium
control group
PLACEBO COMPARATORAnerning particle placebo+ceftriaxone sodium
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanming Xie, BA
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy director
Study Record Dates
First Submitted
August 5, 2018
First Posted
September 18, 2018
Study Start
September 22, 2018
Primary Completion
June 30, 2019
Study Completion
December 31, 2019
Last Updated
September 18, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share