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Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02913118
Recruitment Status : Unknown
Verified April 2018 by Qingfeng Pharmaceutical Group.
Recruitment status was:  Recruiting
First Posted : September 23, 2016
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Qingfeng Pharmaceutical Group

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.

Condition or disease Intervention/treatment Phase
Community Acquired Pneumonia Drug: Andrographolid Sulfonate Injection (AS Injection) Drug: Cephalosporin Drug: Azithromycin, Minocycline or Doxycycline Drug: Amoxicillin-clavulantic acid Drug: Fluoroquinolones Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia: A Multicenter Randomized Controlled Clinical Trial
Study Start Date : July 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: standard antibiotic treatment +AS injection
Andrographolid Sulfonate Injection (AS Injection) plus one of 3 antibiotics in China CAP Guideline
Drug: Andrographolid Sulfonate Injection (AS Injection)
Drug: Cephalosporin
Drug: Azithromycin, Minocycline or Doxycycline
Drug: Amoxicillin-clavulantic acid
Drug: Fluoroquinolones
Placebo Comparator: standard antibiotic treatment + AS placebo
AS placebo (NS injection) plus one of 3 antibiotics in China CAP Guideline
Drug: Cephalosporin
Drug: Azithromycin, Minocycline or Doxycycline
Drug: Amoxicillin-clavulantic acid
Drug: Fluoroquinolones
Drug: Placebo



Primary Outcome Measures :
  1. time to clinical stability [ Time Frame: 14 days ]
  2. 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 Outcome Measures :
  1. the duration of fever [ Time Frame: 14 days ]
  2. the initial treatment failure rate [ Time Frame: 14 days ]
  3. length of stay in hospital [ Time Frame: 14 days ]
  4. questionnaire for hospitalization expenses [ Time Frame: 14 days ]
  5. the duration of intravenous antibiotic treatment [ Time Frame: 14 days ]
  6. the rate of diarrhea and intestinal dysbacteriosis [ Time Frame: 14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913118


Contacts
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Contact: Chen Wang, Professor +86 13901122992 cyh-birm@263.net
Contact: Bin Cao, Professor +86 13911318339 caobin_ben@163.com

Locations
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China, Beijing
China-Japan Friendship Hospital Recruiting
Beijing, Beijing, China, 100029
Contact: Xiaojing Cui, MD    +86 10 84206269    cuixiaojing86@163.com   
Contact: Bin Cao, MD    +86 13911318339    caobin_ben@163.com   
Beijing Chaoyang Hospital Active, not recruiting
Beijing, Beijing, China
Beijing Hospital of TCM Active, not recruiting
Beijing, Beijing, China
Beijing LuHe Hospital, Capital Medical University Active, not recruiting
Beijing, Beijing, China
Fu Xing Hospital, Capital Medical Unviersity Recruiting
Beijing, Beijing, China
Contact: Jin Chen, MD         
China, Fujian
The First Affiliated Hospital of Wenzhou University Active, not recruiting
Wenzhou, Fujian, China
China, Hebei
First Hospital of QinHuangDao Active, not recruiting
QinHuangDao, Hebei, China
The Second Hospital of Hebei Medical University Active, not recruiting
Shijiazhuang, Hebei, China
China, Jiangsu
Nanjing General Hospital Active, not recruiting
Nanjing, Jiangsu, China
China, Jiangxi
The First Affiliated Hospital of NanChang University Active, not recruiting
NanChang, Jiangxi, China
China, Liaoning
The First Hospital of China Medical University Active, not recruiting
Shenyang, Liaoning, China
China, Shandong
Qingdao Municipal Hospital Active, not recruiting
Qingdao, Shandong, China
The Central Hospital of ZiBo City Active, not recruiting
ZiBo, Shandong, China
China, Shanxi
The First Hospital of Shanxi Medical University Active, not recruiting
Taiyuan, Shanxi, China
China, Sichuan
West China Hospital, Sichuan University Active, not recruiting
Chengdu, Sichuan, China
China, Tianjin
The General Hospital of Tianjin Medical University Active, not recruiting
Tianjin, Tianjin, China
Sponsors and Collaborators
Qingfeng Pharmaceutical Group
Investigators
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Principal Investigator: Chen Wang, Professor China-Japan Friendship Hospital
Principal Investigator: Bin Cao, Professor China-Japan Friendship Hospital
Principal Investigator: Jin Chen, Professor Fu Xing Hospital, Capital Medical University
Principal Investigator: Yuguang Wang, Professor Beijing Hospital of TCM
Principal Investigator: Li Gu, Professor Beijing Chao Yang Hospital
Principal Investigator: Zhenyang Xu, Professor Luhe Hospital, Capital Medical University
Principal Investigator: Yan Yi, Professor First Hospital of China Medical University
Principal Investigator: Wei Zhang, Professor The First Affiliated Hospital of Nanchang University
Principal Investigator: Shufeng Xu, Professor First Hospital of Qinhuangdao
Principal Investigator: Bo Liu, Professor The Central Hospital of ZiBo City
Principal Investigator: Jie Cao, Professor The General Hospital of TianJin Medical University
Principal Investigator: Yuping Li, Professor The First Affiliated Hospital of Wenzhou University
Principal Investigator: Xuedong Liu, Professor Qingdao Municipal Hospital
Principal Investigator: Hong Fan, Professor West China Hospital
Principal Investigator: Zhigang Cai, Professor The Second Hospital of Hebei Medical University
Principal Investigator: Xinri Zhang, Professor The First Affiliated Hospital of Shanxi Medical University
Principal Investigator: Xin Su, Professor Nanjing General Hospital
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Responsible Party: Qingfeng Pharmaceutical Group
ClinicalTrials.gov Identifier: NCT02913118    
Other Study ID Numbers: QF-CAP-20160402
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Azithromycin
Doxycycline
Minocycline
Cephalosporins
Fluoroquinolones
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action