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Clinical evaluation for traditional Chinese medicine combined with antibiotics in the treatment of bacterial pneumonia in children

A randomized, double-blind, placebo-controlled, multicenter clinical trial for efficacy and safety of traditional Chinese medicine combined with antibiotics in the treatment of bacterial pneumonia in children

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025354
Enrollment
Unknown
Registered
2019-08-24
Start date
2020-10-20
Completion date
Unknown
Last updated
2019-10-14

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

Conditions

Bacterial pneumonia in children

Interventions

Sponsors

Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 5 Years

Inclusion criteria

Inclusion criteria: 1. Male and female children aged less than 5 years and older than 1 years; 2. Children with community-acquired pneumonia meet the following criteria: (1) The imaging findings (chest X-ray or chest CT) are consistent with the characteristics of bacterial pneumonia: new or progressive infiltrating inflammation of the lung. Chest X-ray show punctate or patchy infiltration shadow of pulmonary parenchyma, or increased texture, blurred or striped shadow in both lungs, or even clustered into reticular, or deepened shadow of hilum, or even infiltration around hilum. Chest CT show patchy and nodular increased density shadow, or pulmonary texture thickening and patchy increased density shadow. And (2) acute course of disease (38.5 degree C); d. dyspnea or shortness of breath or hypoxemia (SPO 2 saturation in indoor air 10^9/L, neutrophil percentage > 50%; g. C reactive protein > 10mg/L; h. PCT > 0.5ug/L. 3.Meet TCM syndrome differentiation criteria of asthma and cough of pneumonia, wind-heat stagnation of lung syndrome: Guidelines for Diagnosis and Treatment of Common Diseases in Pediatrics of TCM(2012) by Chinese Academy of Traditional Chinese Medicine. Wind-heat stagnation of lung: main symptoms: fever; cough; asthma and nasal agitation; yellow phlegm or phlegm hoarseness in the throat. Secondary symptoms: nasal obstruction, runny or yellow; pharynx red; headache; reddish complexion; thirst; constipation; yellow urine. Tongue, pulse and fingerprint: red tongue; thin yellow fur; pulse floating and fast, fingerprint floating purple. With at least two main symptoms and at least two secondary symptoms, the diagnosis can be made by referring to the tongue, pulse and fingerprints. 4. Children who can be admitted to hospital for routine treatment; 5. Informed consent process conforms to the requirements, and legal agent signs the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pneumonia is identified or suspected casued by non-community-acquired bacterial pathogens (e.g. ventilator-associated pneumonia, hospital-acquired pneumonia, aspiration pneumonia, suspected viral, fungal, and partial Mycobacterium pneumoniae infections); 2. Non-infectious causes of infiltration (such as pulmonary embolism, chemical pneumonia caused by inhalation, hypersensitivity pneumonitis, congestive heart failure); 3. Pleural empyema (excluding non-suppurative pneumonia pleural effusion); 4. Confirmed or suspected of infection with atypical pathogens based on epidemiological background (Mycoplasma pneumoniae MP antibody titer >=1:160 or IgM positive; Chlamydia pneumoniae single serum IgM titer >=1:16 or Ig G titer >=1:512) Virus (such as Coxsackie virus, influenza A virus, influenza B virus, human parainfluenza virus, human respiratory syncytial virus, adenovirus IgM positive) infected; 5. Including but not limited to pneumonia with bronchial asthma, bronchus Foreign body, pneumonia with measles, whooping cough, influenza; pneumonia with other serious primary diseases of the lung; 6. Community acquired pneumonia need to enter the ICU treatment; 7. 72h before enrollment Those who used antibiotics (except for one-day oral or intravenous short-acting antibiotics; systemic antibacterial therapy >= 48h failure and isolation of previously used systemic antibiotic-resistant pathogenic microorganisms); 8. Oral according to doctor's prescription within 72 hours before enrollment Chinese medicine, Chinese patent medicine treatment (excluding medication >=48h failure); 9. Use traditional Chinese medicine injection within 72 hours before enrollment; 10. Use Chinese medicine used in this test within 72 hours before enrollment (Maxingshigan Tang and Qingfei experience prescription). 11. Use ceftriaxone (or other third-generation cephalosporin antibiotics) to treat this CABP-ineffective person according to clinical or epidemiological background, or to isolate ceftriaxone-resistant pathogenic microorganisms in the early stage of CABP; 12. Previously to ß - lactam antibiotics and allergens used in the study of traditional Chinese medicine components; 13. Previous history of epilepsy or convulsions (except for well-documented children with febrile seizures); 14. For any reason requires simultaneous antibacterial or systemic antifungal treatment Except: topical antifungal or antibacterial treatment, a single oral antibiotic treatment of vaginal candidiasis. 15. Patients with neoplastic lung disease, cystic fibrosis, fatal diseases, chronic neurological diseases affecting the clearance of lung secretions, life expectancy of less than or equal to 3 months; 16. Within 3 days before starting the study treatment plan Use probenecid or if you need to be treated with probenecid; 17. Infection may require the use of systemic corticosteroids simultaneously; 18. Evidence of immediate life-threatening illnesses, including but not limited to current or impending respiratory failure, Acute heart failure, shock, acute liver failure, active gastrointestinal bleeding; 19. Primary disease with heart, liver, kidney, digestion and hematopoietic system; 12-lead ECG abnormalities, including but not limited to: ST-T changes, pathological Q waves, various arrhythmias, such as sinus tachycardia, bradycardia, ventricular premature beats, atrial premature beats, atrial fibrillation, supraventricular and ventricular tachycardia, and various c

Design outcomes

Primary

MeasureTime frame
Clinical cure rate;Antibiotic application days;

Secondary

MeasureTime frame
Complete antipyretic rate;Complete antipyretic days;Achieved the rate of transfer to the ICU indication;Disease efficacy;TCM syndrome effect;Effect time of antipyretic, cough, cough phlegm, antiasthmatic ;Effect of single symptom (fever, cough, cough, asthma) and pulmonary signs;Antibiotics upgrade treatment rates;

Countries

China

Contacts

Public ContactLiping Sun

Affiliated Hospital of Changchun University of Traditional Chinese Medicine

slpwzt7063@163.com+86 0431-86177529

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 16, 2026