Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection

A Randomized Controlled Study of Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection

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.

Study Overview

• Status: Recruiting
• Conditions: Bacterial Infection; Upper Respiratory Tract Infection; Chinese Medicine; Pediatric Acute Upper Respiratory Tract Infection
• Intervention / Treatment: Drug: QingFei Granule; Drug: Cefuroxime

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jun Liu; Phone Number: 8610-64093207; Email: franlj1104@aliyun.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100078
      • Recruiting
      • Dongfang Hospital
      • Contact: Li-Qun Wu, Prof.; Phone Number: 010-67689706

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Diagnosis with the acute upper respiratory tract infection;
2. Diagnosis with wind-heat Zheng according to Chinese medicine;
3. Age: 5-14 years old;
4. Body temperature ≥ 37.5 ℃;
5. White blood cell count> 12 × 10^9 / L, and / or neutrophil ratio over than 70%;
6. 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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QingFei Granule+Cefuroxime group; Cefuroxime：30mg/kg/d,bid QingFei Granule: tid	Drug: QingFei Granule; 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.; Drug: Cefuroxime; 30mg/kg/d,bid, used until to the normalization of blood routine。
Active Comparator: Cefuroxime group; Cefuroxime：30mg/kg/d,bid	Drug: Cefuroxime; 30mg/kg/d,bid, used until to the normalization of blood routine。

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	0, Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 3,Day 5
Fever clearance time	record once every 4 to 8 h after treatment.	Up to Day 5
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.	Up to Day 5
The incidence of the complications	complicated with laryngitis, tracheo-bronchitis, pneumonia, myocarditis and other complications	Up to Day 5
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.	Up to Day 5
The usage of antibiotics (Cefuroxime)	The usage of Cefuroxime (including the usage times and detail amount will be recorded in the patients' dairy.	Up to Day 5
The normalization rate of the blood routine		Day 3, Day 5

Collaborators and Investigators

• Sponsor: Zhong Wang

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Respiratory Tract Infections; Bacterial Infections; Anti-Infective Agents; Anti-Bacterial Agents; Cefuroxime; Cefuroxime axetil
• Other Study ID Numbers: QFKL V3.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No