Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of traditional Chinese medicine for treatment of pediatric pneumonia. It is a multicenter randomized controlled trial.

Detailed Description
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The block randomization is used in this trial. Random numbers are generated by statistical analysis system(SAS) software. Statistical analysis staff and those who perform the follow-up are blinded. Sample size calculation was performed, which was 1164 , and considering drop-out or withdrawal, investigators plan to enroll 1500 patients (500 in experimental group 1, 500 in experimental group 2, 500 in experimental group 3).

Official Title
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Assessing the Effectiveness of Integrative Treatment That Combines Interior and Exterior Treatment Plans in Pediatric Pneumonia: a Program by the Special Scientific Research Fund of Public Welfare Profession of China

Conditions
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Pneumonia

Intervention / Treatment
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* Drug: Xiyanping injection
* Drug: wind-heat formula granules
* Drug: phlegm-heat formula granules
* Drug: Fu-xiong San
* Drug: second generation cephalosporin
* Drug: Erythromycin
* Drug: Azithromycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children,aged 1 to 14 years old; diagnosed as pneumonia according to western medicine diagnostic criteria; diagnosed as TCM pneumonia with pneumonia with dyspnea and cough, meeting wind-heat blocking lungs pattern (feng re bi fei zheng), and phlegm-heat blocking lungs pattern(tan re bi fei zheng); disease progression within 72 hours; those whose guardians understood and assigned the informed consent; Exclusion Criteria: severe pneumonia; complicated with other Pulmonary Disorders attack other than pneumonia; complicated with primary disease of heart(congenital heart disease, myocarditis, et al),liver(alanine aminotransferase(ALT),and aspartate transaminase(AST) ≥1.5 times of normal value ceiling),kidney (blood urea nitrogen(BUN) >8.2mmol/l, or serum C reactive protein >104umol/l,et al) and blood system (anemia) ,and those with psychopathy; allergic to interventional medications; those who are participating or have participated in other clinical trials in 3 months; those who intend to lost follow-up by practitioners' judgment.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injection,medications and application<br>Intravenous injection: bacterial pneumonia: second generation cephalosporin; mycoplasma pneumonia: erythromycin or azithromycin; viral pneumonia: Xiyanping injection, produced by Jiangxi Qing Feng Pharmaceutical Co.,Ltd; Medications: according to TCM syndrome differentiations; Wind-heat blocking lungs pattern(feng re bi fei zheng): wind-heat formula granules; phlegm-heat blocking lungs pattern(tan re bi fei zheng): phlegm-heat formula granules; external application: Fu-xiong San. | Drug: Xiyanping injection<br>* ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection<br>Drug: wind-heat formula granules<br>* children aged 6 months to 3-year old: 1/2 packet，orally taken two times daily or frequency; children aged 3 to 5-year old: 2/3 packet，orally taken two times daily or frequency; children aged 5 to 14-year old: 1 packet， orally taken two times daily or frequency<br>Drug: phlegm-heat formula granules<br>* children aged 6 months to 3-year old: 1/2 packet，orally taken two times daily or frequency; children aged 3 to 5-year old: 2/3 packet，orally taken two times daily or frequency; children aged 5 to 14-year old: 1 packet， orally taken two times daily or frequency<br>Drug: Fu-xiong San<br>* external application; 8-10 cm wide, 0.3-0.5 cm thick;10 mins for patient aged 1 to 3-year old; 15 mins for those aged 3 to 5-year old; once daily<br>Drug: second generation cephalosporin<br> <br> Drug: Erythromycin<br>* ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection<br>Drug: Azithromycin<br>* ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection<br>|
| Experimental: Injection and medications<br>Intravenous injection: bacterial pneumonia：second generation cephalosporin; mycoplasma pneumonia：erythromycin or azithromycin; viral pneumonia：Xiyanping injection, produced by Jiangxi Qing Feng Pharmaceutical Co.,Ltd; Medications: according to TCM syndrome differentiations; Wind-heat blocking lungs pattern(feng re bi fei zheng): wind-heat formula granules; phlegm-heat blocking lungs pattern(tan re bi fei zheng): phlegm-heat formula granules. | Drug: Xiyanping injection<br>* ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection<br>Drug: wind-heat formula granules<br>* children aged 6 months to 3-year old: 1/2 packet，orally taken two times daily or frequency; children aged 3 to 5-year old: 2/3 packet，orally taken two times daily or frequency; children aged 5 to 14-year old: 1 packet， orally taken two times daily or frequency<br>Drug: phlegm-heat formula granules<br>* children aged 6 months to 3-year old: 1/2 packet，orally taken two times daily or frequency; children aged 3 to 5-year old: 2/3 packet，orally taken two times daily or frequency; children aged 5 to 14-year old: 1 packet， orally taken two times daily or frequency<br>Drug: second generation cephalosporin<br> <br> Drug: Erythromycin<br>* ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection<br>Drug: Azithromycin<br>* ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection<br>|
| Experimental: Injection and application<br>Intravenous injection: bacterial pneumonia: second generation cephalosporin; mycoplasma pneumonia: erythromycin or azithromycin; viral pneumonia: Xiyanping injection, produced by Jiangxi Qing Feng Pharmaceutical Co.,Ltd; external application: Fu-xiong San. | Drug: Xiyanping injection<br>* ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection<br>Drug: Fu-xiong San<br>* external application; 8-10 cm wide, 0.3-0.5 cm thick;10 mins for patient aged 1 to 3-year old; 15 mins for those aged 3 to 5-year old; once daily<br>Drug: second generation cephalosporin<br> <br> Drug: Erythromycin<br>* ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection<br>Drug: Azithromycin<br>* ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cured rate (clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded) | clinical symptoms and signs totally disappear, the period of lab tests return to normal is recorded | every day since receiving treatment,all together 7 days (times) | 
| effective time window (days range from treatment is received to the effectiveness is observed, and symptoms disappear) | days range from treatment is received to the effectiveness is observed, and symptoms disappear | every day since receiving treatment, all together 7 days (times) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect in treating fever | temperature, fever frequency,fever lasting time, Ibuprofen Suspension， all to be measured | 7 days | 
| effect in dyspnea releasing | gasp frequency, severity, all to be measured | 7 days | 
| effect in phlegm releasing | phlegm amount,color and nature to be measured | 7 days | 
| effect in cough releasing | cough severity to be measured | 7 days | 
| time from admission to recovery of rales |  | 7 days | 
| TCM syndrome scores | measure is a composite. | 7 days | 
| effective rate of TCM syndrome scores | total effecive rate according to TCM syndrome differentiation and treatment, and single syndrome effective rate | 7 days | 
| check-out time (days counted when the patient checks out) | days counted when the patient checks out | 7 days | 
| pulmonary disease incidence (prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up) | prolonged pneumonia, chronic cough, cough variant asthma incidence in the follow-up | 15 days; 30 days; 90 days | 
| safety (With adverse events as the calculation basis) | With adverse events as the calculation basis | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pneumonia, pediatrics