Community Acquired Pneumonia
Conditions
Brief summary
Adjunctive Therapy of AndrographolidSulfonate in Community Acquired Pneumonia: A Multicenter, Randomized,Double-blinded, Placebo Controlled Clinical Trial. The hypothesis is that combination therapy with Andrographolid Sulfonatein injection and antibacterial is significantly better than antibacterial alone in achieving clinical stability among hospitalized CAP patients.
Interventions
DRUGAndrographolid Sulfonate Injection (AS Injection)
DRUGCephalosporin
DRUGAzithromycin, Minocycline or Doxycycline
DRUGAmoxicillin-clavulantic acid
DRUGFluoroquinolones
DRUGPlacebo
Sponsors
Qingfeng Pharmaceutical Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age of 18-75 years, no gender restrictions. * Voluntary participation, all participants provide written informed consent. * Volunteers are hospitalized patients * Patients are hospitalized for community acquired pneumonia with T≥38°C within 24 hours before being enrolled Diagnosis of CAP(Chinese Guideline for Diagnosis and Management of Community Acquired Pneumonia in Adults 2016) 1. Pneumonia that is acquired in community 2. Symptoms and signs of pneumonia: <!-- --> 1. Presence of cough, expectoration or exacerbation of chronic airways disease, with or without purulent sputum/chest pain/dyspnea/hemoptysis. 2. Presence offever. 3. Lung consolidation and/or moist rales. 4. Peripheral blood（WBC）\>10×109/L or \<4×109/L, with or without nuclear left shift; 3. Chest radiograph shows new ground-glass opacity, patchy infiltration, consolidation or interstitial changes, with or without pleural effusion. Patients who meet 1,3 and any one item in 2, exclude one of the following are clinically classified as CAP: pulmonary tuberculosis, cancer, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophilia and pulmonary vasculitis. * CURB 65≥1 point,Each risk factor scores one point, for a maximum score of 5: * Confusion of new onset * Blood Urea nitrogen greater than 7 mmol/l (19 mg/dL) * Respiratory rate of 30 breaths per minute or greater * Blood pressure less than 90 mmHg systolic or diastolic blood pressure 60 mmHg or less * Age 65 or older * Within 72 hours after symptom onset
Exclusion criteria
* Known allergy to AS * Pregnant or breast-feeding * Heart dysfunction, NYHA III-IV class * Hematological system diseases, such as lymphoma, leukemia, agranulocytosis (neutrophil count\< 0.5×109/L). * Autoimmune diseases and disease active * Terminal malignant tumor * Long-term treatment of high dose corticosteroids (prednisone 10mg/d ≥2 weeks) or immunosuppressive agents * Inflammatory bowel disease, such as Crohn's disease, ulcerative colitis * Chronic renal failure, eGFR\<50 ml/min/1.73m2 * Severe liver function damage, ALT or AST greater than or equal to 2 times the upper limit of normal * Hypernatremia, serum sodium≥145mmol/L * Diagnosis as severe pneumonia: Diagnostic criteria of severe pneumonia: patients who meet one major criteria or at least 3 of these minor criteria are classified as severe cases: Major criteria:①the need for invasive mechanical ventilation②sepsis shock after active fluid resuscitation still need vasoactive drugs; Minor criteria:①respiratory rate \>30 breaths/min, ②PaO2/FiO2≤250mmHg（1mmHg=0.133kPa）, ③multilobar infiltrates, ④confusion or/andunorientation, ⑤bloodurea nitrogen level≥20mg/dl（7.14mmol/L）, ⑥systolic pressure \<90mmHg need active fluid resuscitation * Defervescence by using corticosteroid after symptom onset. * Patients who participated another intervention study within a month * Other conditions not suitable for inclusion according to the investigator' judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to clinical stability | 14 days | — |
| number of study participants with treatment-related adverse events as assessed by CTCAE v4.0 | 14 days | symptoms and signs, blood and urine routine, liver and kidney function monitoring, ECG, side effects of long-time using of antibiotics |
Secondary
| Measure | Time frame |
|---|---|
| length of stay in hospital | 14 days |
| questionnaire for hospitalization expenses | 14 days |
| the duration of fever | 14 days |
| the rate of diarrhea and intestinal dysbacteriosis | 14 days |
| the duration of intravenous antibiotic treatment | 14 days |
| the initial treatment failure rate | 14 days |
Countries
China
Contacts
Primary ContactChen Wang, Professor
Backup ContactBin Cao, Professor
Outcome results
None listed