Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia

Overview

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.

Full Title of Study: “Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia: A Multicenter Randomized Controlled Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 2019

Interventions

  • Drug: Andrographolid Sulfonate Injection (AS Injection)
  • Drug: Cephalosporin
  • Drug: Azithromycin, Minocycline or Doxycycline
  • Drug: Amoxicillin-clavulantic acid
  • Drug: Fluoroquinolones
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: standard antibiotic treatment +AS injection
    • Andrographolid Sulfonate Injection (AS Injection) plus one of 3 antibiotics in China CAP Guideline
  • Placebo Comparator: standard antibiotic treatment + AS placebo
    • AS placebo (NS injection) plus one of 3 antibiotics in China CAP Guideline

Clinical Trial Outcome Measures

Primary Measures

  • time to clinical stability
    • Time Frame: 14 days
  • number of study participants with treatment-related adverse events as assessed by CTCAE v4.0
    • Time Frame: 14 days
    • symptoms and signs, blood and urine routine, liver and kidney function monitoring, ECG, side effects of long-time using of antibiotics

Secondary Measures

  • the duration of fever
    • Time Frame: 14 days
  • the initial treatment failure rate
    • Time Frame: 14 days
  • length of stay in hospital
    • Time Frame: 14 days
  • questionnaire for hospitalization expenses
    • Time Frame: 14 days
  • the duration of intravenous antibiotic treatment
    • Time Frame: 14 days
  • the rate of diarrhea and intestinal dysbacteriosis
    • Time Frame: 14 days

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Qingfeng Pharmaceutical Group
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chen Wang, Professor, Principal Investigator, China-Japan Friendship Hospital
    • Bin Cao, Professor, Principal Investigator, China-Japan Friendship Hospital
    • Jin Chen, Professor, Principal Investigator, Fu Xing Hospital, Capital Medical University
    • Yuguang Wang, Professor, Principal Investigator, Beijing Hospital of TCM
    • Li Gu, Professor, Principal Investigator, Beijing Chao Yang Hospital
    • Zhenyang Xu, Professor, Principal Investigator, Beijing Luhe Hospital, Capital Medical University
    • Yan Yi, Professor, Principal Investigator, First Hospital of China Medical University
    • Wei Zhang, Professor, Principal Investigator, The First Affiliated Hospital of Nanchang University
    • Shufeng Xu, Professor, Principal Investigator, First Hospital of Qinhuangdao
    • Bo Liu, Professor, Principal Investigator, The Central Hospital of ZiBo City
    • Jie Cao, Professor, Principal Investigator, The General Hospital of TianJin Medical University
    • Yuping Li, Professor, Principal Investigator, The First Affiliated Hospital of Wenzhou University
    • Xuedong Liu, Professor, Principal Investigator, Qingdao Municipal Hospital
    • Hong Fan, Professor, Principal Investigator, West China Hospital
    • Zhigang Cai, Professor, Principal Investigator, The Second Hospital of Hebei Medical University
    • Xinri Zhang, Professor, Principal Investigator, The First Affiliated Hospital of Shanxi Medical University
    • Xin Su, Professor, Principal Investigator, Nanjing General Hospital
  • Overall Contact(s)
    • Chen Wang, Professor, +86 13901122992, cyh-birm@263.net

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