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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

Tracking Information
First Submitted Date  ICMJE September 12, 2016
First Posted Date  ICMJE September 23, 2016
Last Update Posted Date April 10, 2018
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia
Official Title  ICMJE Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia: A Multicenter Randomized Controlled Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Community Acquired Pneumonia
Intervention  ICMJE
  • Drug: Andrographolid Sulfonate Injection (AS Injection)
  • Drug: Cephalosporin
  • Drug: Azithromycin, Minocycline or Doxycycline
  • Drug: Amoxicillin-clavulantic acid
  • Drug: Fluoroquinolones
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: standard antibiotic treatment +AS injection
    Andrographolid Sulfonate Injection (AS Injection) plus one of 3 antibiotics in China CAP Guideline
    Interventions:
    • 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
    Interventions:
    • Drug: Cephalosporin
    • Drug: Azithromycin, Minocycline or Doxycycline
    • Drug: Amoxicillin-clavulantic acid
    • Drug: Fluoroquinolones
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 21, 2016)
462
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02913118
Other Study ID Numbers  ICMJE QF-CAP-20160402
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qingfeng Pharmaceutical Group
Study Sponsor  ICMJE Qingfeng Pharmaceutical Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Qingfeng Pharmaceutical Group
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP