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Changes of respiratory tract microorganisms in children with pneumonia and the effect of QingFeiYin on respiratory tract microorganisms in children with bacterial pneumonia

Changes of respiratory tract microorganisms in children with pneumonia and the effect of QingFeiYin on respiratory tract microorganisms in children with bacterial pneumonia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080700
Enrollment
Unknown
Registered
2024-02-05
Start date
2024-02-06
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pneumonia in children

Interventions

Experiment group 1:None
Experiment group A:1.General treatment : If intravenous rehydration is necessary, the total amount of fluid should be calculated according to 80% of the normal requirement of basal metabolism, and ser
Experiment group B:1.General treatment : If intravenous rehydration is necessary, the total amount of fluid should be calculated according to 80% of the normal requirement of basal metabolism, and ser

Sponsors

Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1.Changes of respiratory tract microorganisms in children with pneumonia ( 1 ) In line with the western medicine diagnostic criteria of ' Diagnosis and Treatment Standard of Community Acquired Pneumonia in Children ' ( 2019 Edition ) and ' Diagnosis and Treatment Guideline of Mycoplasma Pneumoniae Pneumonia in Children ' ( 2023 Edition ) ; ( 2 ) In line with the Chinese Medical Association 's " Guidelines for the Diagnosis and Treatment of Common Diseases in Pediatrics of Traditional Chinese Medicine · Pneumonia and Asthma " ( 2012 Edition ) TCM diagnostic criteria ; ( 3 ) Aged from 3 to 17 years old ; ( 4 ) Have not taken traditional Chinese medicine or western medicine within 1 month before inclusion ; ( 5 ) The legal guardian of the child informed consent and signed the informed consent. 2.Effect of Qingfei Decoction on respiratory microorganisms in bacterial pneumonia ( 1 ) Conform to the diagnostic criteria for bacterial pneumonia in children of Western medicine developed by the ' Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia in Children ' ( 2019 Edition ) and the previous clinical trial study of the research group ( China Clinical Trial Registry registration number : ChiCTR 1900025354 ) ; ( 2 ) In line with the Chinese Medical Association 's ' Guidelines for the Diagnosis and Treatment of Common Diseases in Pediatrics of Traditional Chinese Medicine • Pneumonia Asthma ' wind-heat stagnation lung syndrome TCM diagnostic criteria ; ( 3 ) Aged from 3 to 17 years old ; ( 4 ) Have not taken traditional Chinese medicine or western medicine within 1 month before inclusion ; ( 5 ) The legal guardian of the child informed consent and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1.Changes of respiratory tract microorganisms in children with pneumonia ( 1 ) Confirmed or suspected pneumonia caused by non-community-acquired pathogens ( e.g., ventilator-associated pneumonia, hospital-acquired pneumonia, aspiration pneumonia ) ; ( 2 ) Non-infectious causes of pulmonary infiltration ( such as pulmonary embolism, inhalation-induced chemical pneumonia, allergic pneumonia, congestive heart failure ) ; ( 3 ) pleural empyema ( excluding non-suppurative pneumonia pleural effusion ) ; ( 4 ) Including but not limited to pneumonia with bronchial asthma, bronchial foreign body ; pneumonia combined with measles, pertussis, influenza ; pneumonia combined with other severe primary lung diseases ; ( 5 ) Patients with community-acquired pneumonia who needed to be treated in ICU ; ( 6 ) Patients who used antiviral, antibiotic or traditional Chinese medicine injections within 72 hours before enrollment ; ( 7 ) Evidence of immediate life-threatening diseases, including, but not limited to, current or impending respiratory failure, acute heart failure, shock, acute liver failure, active gastrointestinal bleeding ; ( 8 ) patients with pneumonia complicated with primary other systemic diseases ; ( 9 ) those who are unable or unwilling to comply with the procedures and restrictions specified in the study. 2.Effect of Qingfei Decoction on respiratory microorganisms in bacterial pneumonia ( 1 ) Confirmed or suspected pneumonia caused by non-community-acquired pathogens ( e.g., ventilator-associated pneumonia, hospital-acquired pneumonia, aspiration pneumonia ) ; ( 2 ) Non-infectious causes of pulmonary infiltration ( such as pulmonary embolism, inhalation-induced chemical pneumonia, allergic pneumonia, congestive heart failure ) ; ( 3 ) pleural empyema ( excluding non-suppurative pneumonia pleural effusion ) ; ( 4 ) Patients who were confirmed or suspected to be infected with atypical pathogens according to epidemiological background ( MP antibody titer = 1 : 160 or IgM positive ; chlamydia pneumoniae single serum IgM titer = 1 : 16 or IgG titer = 1 : 512 ) ; virus ( such as Coxsackie virus, influenza A virus, influenza B virus, human parainfluenza virus, human respiratory syncytial virus, adenovirus IgM positive ) infection ; ( 5 ) Including but not limited to pneumonia with bronchial asthma, bronchial foreign body ; pneumonia combined with measles, pertussis, influenza ; pneumonia combined with other severe primary lung diseases ; ( 6 ) community-acquired pneumonia need to enter the ICU treatment ; ( 7 ) Patients who used antibiotics within 72 hours before enrollment ( except for single-day oral or intravenous short-acting antibiotics ; ( 8 ) Patients who were allergic to ß-lactam antibiotics and traditional Chinese medicine components used in previous studies ; ( 9 ) Evidence of immediately life-threatening diseases, including, but not limited to, current or impending respiratory failure, acute heart failure, shock, acute liver failure, active gastrointestinal bleeding ; ( 10 ) patients with pneumonia complicated with primary other systemic diseases ; ( 11 ) those who are unable or unwilling to comply with the procedures and restrictions specified in the study.

Design outcomes

Primary

MeasureTime frame
Oropharyngeal microbial metagenomic sequencing;

Countries

China

Contacts

Public ContactLiping Sun

Affiliated Hospital of Changchun University of Traditional Chinese Medicine

slpwzt7063@163.com+86 431 8195 3763

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026