Upper Respiratory Tract InfectionNCT03461692
A Registry Study of 100 Thousand Cases of Pediatric Patients on Reduning Injection（a Chinese Medicine Injection）Used in Hospitals in China
An observational study of Upper Respiratory Tract Infection and Acute Tracheobronchitis, run by China Academy of Chinese Medical Sciences.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 14 years
- Conditions the study is for
- Upper Respiratory Tract Infection, Acute Tracheobronchitis
- What is being tested?
- patients under 14 years of age using Reduning injeciton
- Type of treatment
- Injection or infusion
- How many people
- 100,000 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2018to 31 Dec 2018
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: The aim population for observation of clinical characteristics and adverse reactionsis who using Reduning injection from February 2018 to December 2018.
Who may be able to join
- Patients aged 14 and below using Reduning injection from February 2018 to December 2018.
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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.
Read the 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.
- Being tested
- patients under 14 years of age using Reduning injeciton
- Medical subject headings
- Respiratory Tract Infections, Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients under 14 years of age using Reduning injecitonDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days
Secondary outcomes (3)
The Ratio of Body Temperature to Normal
The Ratio of Body Temperature to Normal(Lower Than 37.3ºC)
Measured: 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)
Measured: 3 days
The Ratio of The Antibiotic Used
Calculating The Ratio of Patients Using Antibiotics Accounted for All Patients Using Reduning Injection.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start10 Mar 2018 (estimated)
- Primary completion10 Mar 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Nanjing Medical University, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Qilu Children's Hospital of Shandong University, Zhengzhou Children's Hospital, China
- Responsible party
- Principal investigator, Yanming Xie, China Academy of Chinese Medical Sciences
- Investigators
- Yanming Xie, BA, Principal investigator, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461692
- Sponsor's protocol ID
- RDN2018
- Status last verified
- Feb 2018
- First submitted
- 11 Feb 2018
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03461692
- Acronym / sponsor ID
- RDN2018
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Children's Hospital of Nanjing Medical University, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Qilu Children's Hospital of Shandong University, Zhengzhou Children's Hospital, China
- Study start
- 10 Mar 2018 (estimated)
- Primary completion
- 10 Mar 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 12 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
Who may qualify
- Ages
- 1 day to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The aim population for observation of clinical characteristics and adverse reactionsis who using Reduning injection from February 2018 to December 2018.
Key inclusion criteria (1 listed)
- Patients aged 14 and below using Reduning injection from February 2018 to December 2018.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patients under 14 years of age using Reduning injecitonTo 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. | Drug | – |
Primary outcome
Incidence of Adverse Drug Reaction
Time frame: 3 days
Incidence of Reduning Injection'Adverse Drug Reaction（ADRs）and Identify Factors That Contributed to the Occurrence of the Adverse Drug Reaction
3 secondary outcomes
The Ratio of Body Temperature to Normal
Time frame: 3 days
The Ratio of WBC to Normal
Time frame: 3 days
The Ratio of The Antibiotic Used
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanming Xie, BA principal investigator
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Respiratory Tract Infection and Acute Tracheobronchitis, run by China Academy of Chinese Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanming Xie, BA (86-13911112416, datamining5288@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Drug Reaction (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.