Acute Tracheobronchitis, Upper Respiratory Tract Infection
Conditions
Brief summary
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in February 2018. The purpose of this study is to make a monitoring of adverse reactions in 100 thousand children aged 14 years and below to see whether Reduning injection is safe and the characteristic and mechanism of anaphylactic reaction used Reduning injection in hospitals in China.
Detailed description
In order to observe the clinical characteristics and adverse reactions of patients aged 14 and below using Reduning injection in hospital,registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of anaphylaxis. Calculating the incidence of adverse drug reactions is one of the main aims for this study. 100000 cases need to be registered at least. The aim population is who using Reduning injection from February 2018 to December 2018.
Interventions
DRUGpatients under 14 years of age using Reduning injeciton
To assess in patients using Reduning injection's clinical features and drug adverse reaction during patients' hospital stay. The registry procedure will only for patients under 14 years of age using Reduning injection,observed from February 2018 to December 2018.
Sponsors
Children's Hospital of Nanjing Medical University
Hunan University of Traditional Chinese Medicine
Qilu Children's Hospital of Shandong University
Zhengzhou Children's Hospital, China
China Academy of Chinese Medical Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 14 Years
Healthy volunteers
No
Inclusion criteria
Patients aged 14 and below using Reduning injection from February 2018 to December 2018.
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Drug Reaction | 3 days | Incidence of Reduning Injection'Adverse Drug Reaction（ADRs）and Identify Factors That Contributed to the Occurrence of the Adverse Drug Reaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Ratio of Body Temperature to Normal | 3 days | The Ratio of Body Temperature to Normal(Lower Than 37.3ºC) |
| The Ratio of WBC to Normal | 3 days | The Ratio of Body Temperature to Normal(Within the Range of (4 to 10) x the 9 square of 10/L) |
| The Ratio of The Antibiotic Used | 3 days | Calculating The Ratio of Patients Using Antibiotics Accounted for All Patients Using Reduning Injection. |
Contacts
Primary ContactYanming Xie, BA
Backup ContactLianxin Wang, doctor
Outcome results
None listed