ITMCTR1900002538尚未招募1 期
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
Affiliated Hospital of Changchun University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 1 至 5（—）
- 性别
- All
入选标准
- •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 (< 5 days); and
- •(3) at least three clinical manifestations meet the following symptoms or signs of lower respiratory tract infection; a. new onset or aggravation of cough;
- •b. purulent sputum or a change in the nature of the sputum;
- •c. axillary temperature (>38.5 degree C);
- •d. dyspnea or shortness of breath or hypoxemia (SPO 2 saturation in indoor air < 92%) (sea level) or < 90% (plateau); e. lung auscultation consistent with pneumonia auscultation (early rough or reducing breathing sounds can be heard and coarsening or dry-wet rales or tubular breathing sounds can be heard lately);
- •f. white blood cell count > 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.
排除标准
- •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
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