Community-acquired PneumoniaPhase 4NCT03675178
Clinical Study of Anerning Particle for the Treatment of Childhood Community-acquired Pneumonia
A Phase 4 study testing Anerning particle in people with Community-acquired Pneumonia, run by China Academy of Chinese Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Anerning particle
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- 22 Sep 2018to 31 Dec 2019
- Phase
- Phase 4
- 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 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meet the diagnostic criteria for children's CAP Western medicine and consider bacterial infection;
- Those who meet the diagnostic criteria of TCM syndrome differentiation of wind-heat and closed lung syndrome;
- Children aged 1 to 5 years old;
- Within 48 hours of onset of CAP;
- The informed consent process is in compliance with the regulations, and the legal representative signs the informed consent form.
Who cannot join
- Chest X-ray films showed obvious lung tumors and tuberculosis;
- Those with acute infectious diseases such as measles, whooping cough, and influenza;
- Other upper respiratory tract infections, wheezing-like bronchitis, bronchial asthma, bronchial foreign bodies and other respiratory diseases;
- Children with severe malnutrition and immunodeficiency;
- Combine severe primary diseases such as severe heart, liver, kidney, digestion and hematopoietic system;
- Those who meet the CAP (severe) Western diagnostic criteria for children;
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- Clinically diagnosed or clinically considered viral pneumonia, Mycoplasma pneumoniae pneumonia;
- allergic constitution (allergic to more than 2 types of substances), or allergic to penicillins, cephalosporin antibiotics and Anering granules and their components;
- Researchers believe that it is not appropriate to join the group.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Anerning Particle for Reducing the Application of Antibiotics of Childhood Community-acquired Pneumonia: a Randomized, Double Blind, Control of Placebo, Multi-center Clinical Study
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.
Read the 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
- Being tested
- Anerning particle, control group
- Keywords
- Anerning particle, Clinical endpoint antibiotic application frequency, efficacy and safety, randomized, double blind
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anerning particleDrug
Also called ceftriaxone sodium
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.
control groupDrug
Also called Anerning particle placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Anerning particle +ceftriaxone sodium Receives: Drug: Anerning particle |
| control group | Placebo comparator | Anerning particle placebo+ceftriaxone sodium Receives: Drug: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether Anerning particle can reduce the use of antibiotics
Frequency of antibiotics (DDDs) at clinical endpoints of the two groups
Measured: After 10 days of medication.When the condition is cured, stop the medicine at any time.
Secondary outcomes (3)
The chest X-ray of 216 participants will be assessed.
If the chest radiograph returns to normal, it indicates that the patient has recovered.
Measured: The maximum time for administration according to the protocol is 10 days, and the drug can be stopped at any time during clinical cure. If it is not good to change on the 6th day of treatment, use other measures.
The blood routine and c-reactive protein of 216 participants will be assessed.
Combined detection of c-reactive protein and white blood cell， if the two indicators return to normal after treatment, the child recovers.
Measured: The maximum time for administration according to the protocol is 10 days, and the drug can be stopped at any time during clinical cure. If it is not good to change on the 6th day of treatment, use other measures.
Complete fever time
Judging criteria: body temperature (underarm temperature) <37.3 ° C, and maintained for 24h and above. Measurement method: measured every 8h.
Measured: The maximum time for administration according to the protocol is 10 days, and the drug can be stopped at any time during clinical cure. If it is not good to change on the 6th day of treatment, use other measures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start22 Sep 2018 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
- 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
- NCT03675178
- Sponsor's protocol ID
- Anerning particle
- Status last verified
- Sep 2018
- First submitted
- 5 Aug 2018
- Last updated
- 18 Sep 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 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anerning Particle for Reducing the Application of Antibiotics of Childhood Community-acquired Pneumonia: a Randomized, Double Blind, Control of Placebo, Multi-center Clinical Study
- ClinicalTrials.gov ID
- NCT03675178
- Acronym / sponsor ID
- Anerning particle
- Conditions
- Community-acquired Pneumonia
- Keywords
- Anerning particle, Clinical endpoint antibiotic application frequency, efficacy and safety, randomized, double blind
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
- Study start
- 22 Sep 2018 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 18 Sep 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Anerning particleAnerning particle +ceftriaxone sodium |
| control group | Placebo comparator | Drug: control groupAnerning particle placebo+ceftriaxone sodium |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Meet the diagnostic criteria for children's CAP Western medicine and consider bacterial infection;
- Those who meet the diagnostic criteria of TCM syndrome differentiation of wind-heat and closed lung syndrome;
- Children aged 1 to 5 years old;
- Within 48 hours of onset of CAP;
- The informed consent process is in compliance with the regulations, and the legal representative signs the informed consent form.
Key exclusion criteria (9 listed)
- Chest X-ray films showed obvious lung tumors and tuberculosis;
- Those with acute infectious diseases such as measles, whooping cough, and influenza;
- Other upper respiratory tract infections, wheezing-like bronchitis, bronchial asthma, bronchial foreign bodies and other respiratory diseases;
- Children with severe malnutrition and immunodeficiency;
- Combine severe primary diseases such as severe heart, liver, kidney, digestion and hematopoietic system;
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 |
|---|---|---|
| Anerning particleAlso: ceftriaxone sodiumAnerning 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 | treatment group |
| control groupAlso: Anerning particle placeboAnerning 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. | Drug | control group |
Primary outcome
Whether Anerning particle can reduce the use of antibiotics
Time frame: After 10 days of medication.When the condition is cured, stop the medicine at any time.
Frequency of antibiotics (DDDs) at clinical endpoints of the two groups
3 secondary outcomes
The chest X-ray of 216 participants will be assessed.
Time frame: The maximum time for administration according to the protocol is 10 days, and the drug can be stopped at any time during clinical cure. If it is not good to change on the 6th day of treatment, use other measures.
The blood routine and c-reactive protein of 216 participants will be assessed.
Time frame: The maximum time for administration according to the protocol is 10 days, and the drug can be stopped at any time during clinical cure. If it is not good to change on the 6th day of treatment, use other measures.
Complete fever time
Time frame: The maximum time for administration according to the protocol is 10 days, and the drug can be stopped at any time during clinical cure. If it is not good to change on the 6th day of treatment, use other measures.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 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?
A Phase 4 study testing Anerning particle in people with Community-acquired Pneumonia, 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 5 inclusion and 9 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 18 Sep 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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, ktzu2018@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether Anerning particle can reduce the use of antibiotics (time frame: After 10 days of medication.When the condition is cured, stop the medicine at any time.). 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 18 Sep 2018.