Suspended

Anerning Particle and Ceftriaxone Sodium for Reduced Antibiotic Use in Childhood Community-Acquired Pneumonia

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What is being tested

Anerning particle

+ control group

Drug
Who is being recruted

Community-Acquired Pneumonia+3

+ Infections

+ Pneumonia

From 1 to 5 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: September 2018
See protocol details

Summary

Principal SponsorChina Academy of Chinese Medical Sciences
Study ContactYanming Xie, BAMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 22, 2018

Actual date on which the first participant was enrolled.

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 TitleAnerning Particle for Reducing the Application of Antibiotics of Childhood Community-acquired Pneumonia: a Randomized, Double Blind, Control of Placebo, Multi-center Clinical Study
NCT03675178
Principal SponsorChina Academy of Chinese Medical Sciences
Study ContactYanming Xie, BAMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

216 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 5 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Community-Acquired PneumoniaInfectionsPneumoniaRespiratory Tract DiseasesRespiratory Tract InfectionsCommunity-Acquired Infections

Criteria

5 inclusion criteria required to participate
The informed consent process is in compliance with the regulations, and the legal representative signs the informed consent form.
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;
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9 exclusion criteria prevent from participating
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;
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Anerning particle +ceftriaxone sodium

Group II

Placebo
Anerning particle placebo+ceftriaxone sodium

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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