Bacterial Infection Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 14 Years |
Eligibility | 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. - |
Country | Name | City | State |
---|---|---|---|
China | Dongfang Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Zhong Wang |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Fever clearance time | record once every 4 to 8 h after treatment. | Up to Day 5 | |
Secondary | 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 | |
Secondary | The incidence of the complications | complicated with laryngitis, tracheo-bronchitis, pneumonia, myocarditis and other complications | Up to Day 5 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | The normalization rate of the blood routine | Day 3, Day 5 |
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