An observational study in Upper Respiratory Tract Infection and Acute Tracheobronchitis, sponsored by China Academy of Chinese Medical Sciences. Status unknown. Open to participants aged 1 Day to 14 Years. Per ClinicalTrials.gov, last updated 2018-03-12.
Sponsored by China Academy of Chinese Medical Sciences · Observational
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.
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.
751 studies on the registry are indexed under Respiratory Tract Infections; 114 are open to participants now.
This study's planned enrollment of 100,000 is above the median of 350 across 184 observational studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →China Academy of Chinese Medical Sciences is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
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The aim population for observation of clinical characteristics and adverse reactionsis who using Reduning injection from February 2018 to December 2018.
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Patients aged 14 and below using Reduning injection from February 2018 to December 2018.
Exclusion Criteria:
None
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.
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
Time frame: 3 days
The Ratio of Body Temperature to Normal
The Ratio of Body Temperature to Normal(Lower Than 37.3ºC)
Time frame: 3 days
The Ratio of WBC to Normal
The Ratio of Body Temperature to Normal(Within the Range of (4 to 10) x the 9 square of 10/L)
Time frame: 3 days
The Ratio of The Antibiotic Used
Calculating The Ratio of Patients Using Antibiotics Accounted for All Patients Using Reduning Injection.
Time frame: 3 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Respiratory Tract Infections →
China Academy of Chinese Medical Sciences