Back to resultsQingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection
Primary Purpose
Upper Respiratory Tract Infection, Bacterial Infection, Chinese Medicine
Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
QingFei Granule
Cefuroxime
Sponsored by
About this trial
This is an interventional treatment trial for Upper Respiratory Tract Infection
Eligibility Criteria
Inclusion Criteria:
- Diagnosis with the acute upper respiratory tract infection;
- Diagnosis with wind-heat Zheng according to Chinese medicine;
- Age: 5-14 years old;
- Body temperature ≥ 37.5 ℃;
- White blood cell count> 12 × 10^9 / L, and / or neutrophil ratio over than 70%;
- The informed consent process complies with the regulations, and the legal agent or the child (≥8 years old) jointly sign the informed consent
Exclusion Criteria:
(1) Acute bacterial otitis media; (2) Patients with periodontitis or periodontal abscess (3) Candidiasis; (4) Patients with positive mycoplasma; (5) Taking antibiotics, anti-inflammatory drugs, and antihistamines; (6) Patients with severe comorbidities of heart, liver and kidney; (7) Other patients with acute infectious diseases and mycoplasma pneumoniae infections with symptoms similar to upper respiratory tract infection; (8) Children with a history of epilepsy or convulsions; (9) Patients with mental illness; (10) Those who are allergic to treatment drugs; (11) Participated in other clinical trials in the past month; (12) The investigator evaluates that it is not suitable to participate in this clinical trial or according to the investigator's judgment, who is likely to loss to follow-up.
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Sites / Locations
- Dongfang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
QingFei Granule+Cefuroxime group
Cefuroxime group
Arm Description
Cefuroxime：30mg/kg/d,bid QingFei Granule: tid
Cefuroxime：30mg/kg/d,bid
Outcomes
Primary Outcome Measures
Bacterial clearance
The pharyngeal swabs were used for sampling, and the pharyngeal flora diversity amplicon sequencing was used to analyze the pharyngeal flora spectrum, and the change of pathogenic bacteria flora spectrum before and after treatment was analyzed to qualitatively judge the bacterial clearance.
Calculate the bacterial clearance rate = (number of people removed / total number of people tested) × 100%
Secondary Outcome Measures
Clinical remission rate of disease
The clinical remission rate of disease is defined as: the main symptoms such as chills, fever, nasal congestion, runny nose, sore throat, cough, etc. alleviate or disappear. Upper respiratory tract infection symptom scale score decreased by more than 70% compared with baseline
Fever clearance time
record once every 4 to 8 h after treatment.
Treatment failure rate
Treatment failure is defined as: body temperature does not decrease for 3 consecutive days, and / or complicated by laryngitis, tracheobronchitis, pneumonia, myocarditis, and / or oral antibiotics are switched to intravenous antibiotics.
The incidence of the complications
complicated with laryngitis, tracheo-bronchitis, pneumonia, myocarditis and other complications
The usage of the ibuprofen
If the temperature is over 38.5℃ or the child feel unbearable discomfort, the child will be given with ibuprofen. The usage of the ibuprofen (including the usage times and detail amount will be recorded in the patients' dairy.
The usage of antibiotics (Cefuroxime)
The usage of Cefuroxime (including the usage times and detail amount will be recorded in the patients' dairy.
The normalization rate of the blood routine
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04479657
Brief Title
Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection
Official Title
A Randomized Controlled Study of Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhong Wang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to assess the antibacterial effect and symptoms-relief of Qingfei Granule in the patients with pediatric acute upper respiratory tract infection with bacterial infection.
Detailed Description
Upper respiratory tract infection is the most common respiratory disease in childhood, and the incidence rate accounts for more than 60% of pediatric outpatients, ranking first in pediatric diseases. At present, antibiotics are commonly used to treat children with upper respiratory tract infections. However, due to the large amount of clinical use of antibiotics in recent years, the resistance of various pathogens has become stronger and stronger, which has caused the majority of clinicians and researchers to turn their attention to traditional Chinese medicine. Qingfei Granule is composed of six common herbal medicines such as Schizonepeta (Jing-Jie),Radix Scutellariae (Huang-qin),Forsythia (Lian-Qiao), etc. After upper respiratory tract infections with bacterial infections, chills, fever, runny nose, red and sore throat may occur, and may be accompanied by mild cough, thin red tongue, yellow moss, floating pulse,which is considered as the exogenous wind-heat Zheng in Chinese medicine. The study aims to assess the antibacterial effect and symptoms-relief of Qingfei Granule in the patients with pediatric acute upper respiratory tract infection with bacterial infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infection, Bacterial Infection, Chinese Medicine, Pediatric Acute Upper Respiratory Tract Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
QingFei Granule+Cefuroxime group
Arm Type
Experimental
Arm Description
Cefuroxime：30mg/kg/d,bid QingFei Granule: tid
Arm Title
Cefuroxime group
Arm Type
Active Comparator
Arm Description
Cefuroxime：30mg/kg/d,bid
Intervention Type
Drug
Intervention Name(s)
QingFei Granule
Intervention Description
QingFei Granule is made from 6 commonly herbal medicine granule, such as Jingjie,Huang Qin,Lianqiao,etc. The children were given one package of QingFei Granule every day, dividing into 3 times to be administrated. It's be given for 5 days.
Intervention Type
Drug
Intervention Name(s)
Cefuroxime
Intervention Description
30mg/kg/d,bid, used until to the normalization of blood routine。
Primary Outcome Measure Information:
Title
Bacterial clearance
Description
The pharyngeal swabs were used for sampling, and the pharyngeal flora diversity amplicon sequencing was used to analyze the pharyngeal flora spectrum, and the change of pathogenic bacteria flora spectrum before and after treatment was analyzed to qualitatively judge the bacterial clearance.
Calculate the bacterial clearance rate = (number of people removed / total number of people tested) × 100%
Time Frame
0, Day 5
Secondary Outcome Measure Information:
Title
Clinical remission rate of disease
Description
The clinical remission rate of disease is defined as: the main symptoms such as chills, fever, nasal congestion, runny nose, sore throat, cough, etc. alleviate or disappear. Upper respiratory tract infection symptom scale score decreased by more than 70% compared with baseline
Time Frame
Day 3,Day 5
Title
Fever clearance time
Description
record once every 4 to 8 h after treatment.
Time Frame
Up to Day 5
Title
Treatment failure rate
Description
Treatment failure is defined as: body temperature does not decrease for 3 consecutive days, and / or complicated by laryngitis, tracheobronchitis, pneumonia, myocarditis, and / or oral antibiotics are switched to intravenous antibiotics.
Time Frame
Up to Day 5
Title
The incidence of the complications
Description
complicated with laryngitis, tracheo-bronchitis, pneumonia, myocarditis and other complications
Time Frame
Up to Day 5
Title
The usage of the ibuprofen
Description
If the temperature is over 38.5℃ or the child feel unbearable discomfort, the child will be given with ibuprofen. The usage of the ibuprofen (including the usage times and detail amount will be recorded in the patients' dairy.
Time Frame
Up to Day 5
Title
The usage of antibiotics (Cefuroxime)
Description
The usage of Cefuroxime (including the usage times and detail amount will be recorded in the patients' dairy.
Time Frame
Up to Day 5
Title
The normalization rate of the blood routine
Time Frame
Day 3, Day 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis with the acute upper respiratory tract infection;
Diagnosis with wind-heat Zheng according to Chinese medicine;
Age: 5-14 years old;
Body temperature ≥ 37.5 ℃;
White blood cell count> 12 × 10^9 / L, and / or neutrophil ratio over than 70%;
The informed consent process complies with the regulations, and the legal agent or the child (≥8 years old) jointly sign the informed consent
Exclusion Criteria:
(1) Acute bacterial otitis media; (2) Patients with periodontitis or periodontal abscess (3) Candidiasis; (4) Patients with positive mycoplasma; (5) Taking antibiotics, anti-inflammatory drugs, and antihistamines; (6) Patients with severe comorbidities of heart, liver and kidney; (7) Other patients with acute infectious diseases and mycoplasma pneumoniae infections with symptoms similar to upper respiratory tract infection; (8) Children with a history of epilepsy or convulsions; (9) Patients with mental illness; (10) Those who are allergic to treatment drugs; (11) Participated in other clinical trials in the past month; (12) The investigator evaluates that it is not suitable to participate in this clinical trial or according to the investigator's judgment, who is likely to loss to follow-up.
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Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Liu
Phone
8610-64093207
Email
franlj1104@aliyun.com
Facility Information:
Facility Name
Dongfang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100078
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li-Qun Wu, Prof.
Phone
010-67689706
12. IPD Sharing Statement
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Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection
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