NCT03675178

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 1 Year – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Community-acquired Pneumonia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-09-22
• Primary completion: 2019-06-30
• Completion: 2019-12-31
• First posted: 2018-09-18
• Last updated: 2018-09-18