A Registry Study of 100 Thousand Cases of Pediatric Patients on Reduning Injection（a Chinese Medicine Injection）Used in Hospitals in China
A Study of 100 Thousand Cases of Pediatric Patients of Clinical Safety Monitoring and Characteristic Observation and the Mechanism of Anaphylactic Reaction Used Reduning(a Chinese Medicine Injection)in Hospitals in China
1 other identifier
observational
100,000
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2018
Shorter than P25 for all trials
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
February 11, 2018
CompletedStudy Start
First participant enrolled
March 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2018
CompletedFirst Posted
Study publicly available on registry
March 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedMarch 12, 2018
February 1, 2018
Same day
February 11, 2018
March 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Adverse Drug Reaction
Incidence of Reduning Injection'Adverse Drug Reaction（ADRs）and Identify Factors That Contributed to the Occurrence of the Adverse Drug Reaction
3 days
Secondary Outcomes (3)
The Ratio of Body Temperature to Normal
3 days
The Ratio of WBC to Normal
3 days
The Ratio of The Antibiotic Used
3 days
Interventions
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.
Eligibility Criteria
The aim population for observation of clinical characteristics and adverse reactionsis who using Reduning injection from February 2018 to December 2018.
You may qualify if:
- Patients aged 14 and below using Reduning injection from February 2018 to December 2018.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Under the patients'premise of consent and the signature of the informed consent, drawing the blood samples 5ml from the patients with allergic reactions and the patients without adverse reactions.The patients who responded to the 1:4 ratio matched the patients who had no adverse reactions (with the same sex, age difference within 5 years as the matching conditions）are intended for inflammatory factors to explore the mechanism of anaphylaxis.
MeSH Terms
Conditions
Condition 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
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 15 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Director
Study Record Dates
First Submitted
February 11, 2018
First Posted
March 12, 2018
Study Start
March 10, 2018
Primary Completion
March 10, 2018
Study Completion
December 31, 2018
Last Updated
March 12, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share