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Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia

Primary Purpose

Community Acquired Pneumonia

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Andrographolid Sulfonate Injection (AS Injection)
Cephalosporin
Azithromycin, Minocycline or Doxycycline
Amoxicillin-clavulantic acid
Fluoroquinolones
Placebo
Sponsored by
Qingfeng Pharmaceutical Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Community Acquired Pneumonia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • China-Japan Friendship HospitalRecruiting
  • Beijing Chaoyang Hospital
  • Beijing Hospital of TCM
  • Beijing LuHe Hospital, Capital Medical University
  • Fu Xing Hospital, Capital Medical UnviersityRecruiting
  • The First Affiliated Hospital of Wenzhou University
  • First Hospital of QinHuangDao
  • The Second Hospital of Hebei Medical University
  • Nanjing General Hospital
  • The First Affiliated Hospital of NanChang University
  • The First Hospital of China Medical University
  • Qingdao Municipal Hospital
  • The Central Hospital of ZiBo City
  • The First Hospital of Shanxi Medical University
  • West China Hospital, Sichuan University
  • The General Hospital of Tianjin Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

standard antibiotic treatment +AS injection

standard antibiotic treatment + AS placebo

Arm Description

Andrographolid Sulfonate Injection (AS Injection) plus one of 3 antibiotics in China CAP Guideline

AS placebo (NS injection) plus one of 3 antibiotics in China CAP Guideline

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

the duration of fever
the initial treatment failure rate
length of stay in hospital
questionnaire for hospitalization expenses
the duration of intravenous antibiotic treatment
the rate of diarrhea and intestinal dysbacteriosis

Full Information

First Posted
September 12, 2016
Last Updated
April 9, 2018
Sponsor
Qingfeng Pharmaceutical Group
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1. Study Identification

Unique Protocol Identification Number
NCT02913118
Brief Title
Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia
Official Title
Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia: A Multicenter Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qingfeng Pharmaceutical Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Acquired Pneumonia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
462 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard antibiotic treatment +AS injection
Arm Type
Experimental
Arm Description
Andrographolid Sulfonate Injection (AS Injection) plus one of 3 antibiotics in China CAP Guideline
Arm Title
standard antibiotic treatment + AS placebo
Arm Type
Placebo Comparator
Arm Description
AS placebo (NS injection) plus one of 3 antibiotics in China CAP Guideline
Intervention Type
Drug
Intervention Name(s)
Andrographolid Sulfonate Injection (AS Injection)
Intervention Type
Drug
Intervention Name(s)
Cephalosporin
Intervention Type
Drug
Intervention Name(s)
Azithromycin, Minocycline or Doxycycline
Intervention Type
Drug
Intervention Name(s)
Amoxicillin-clavulantic acid
Intervention Type
Drug
Intervention Name(s)
Fluoroquinolones
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
time to clinical stability
Time Frame
14 days
Title
number of study participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
symptoms and signs, blood and urine routine, liver and kidney function monitoring, ECG, side effects of long-time using of antibiotics
Time Frame
14 days
Secondary Outcome Measure Information:
Title
the duration of fever
Time Frame
14 days
Title
the initial treatment failure rate
Time Frame
14 days
Title
length of stay in hospital
Time Frame
14 days
Title
questionnaire for hospitalization expenses
Time Frame
14 days
Title
the duration of intravenous antibiotic treatment
Time Frame
14 days
Title
the rate of diarrhea and intestinal dysbacteriosis
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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) Pneumonia that is acquired in community Symptoms and signs of pneumonia: Presence of cough, expectoration or exacerbation of chronic airways disease, with or without purulent sputum/chest pain/dyspnea/hemoptysis. Presence offever. Lung consolidation and/or moist rales. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Wang, Professor
Phone
+86 13901122992
Email
cyh-birm@263.net
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Cao, Professor
Phone
+86 13911318339
Email
caobin_ben@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Wang, Professor
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bin Cao, Professor
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jin Chen, Professor
Organizational Affiliation
Fu Xing Hospital, Capital Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuguang Wang, Professor
Organizational Affiliation
Beijing Hospital of TCM
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li Gu, Professor
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhenyang Xu, Professor
Organizational Affiliation
Beijing Luhe Hospital, Capital Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yan Yi, Professor
Organizational Affiliation
First Hospital of China Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei Zhang, Professor
Organizational Affiliation
The First Affiliated Hospital of Nanchang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shufeng Xu, Professor
Organizational Affiliation
First Hospital of Qinhuangdao
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bo Liu, Professor
Organizational Affiliation
The Central Hospital of ZiBo City
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jie Cao, Professor
Organizational Affiliation
The General Hospital of TianJin Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuping Li, Professor
Organizational Affiliation
The First Affiliated Hospital of Wenzhou University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xuedong Liu, Professor
Organizational Affiliation
Qingdao Municipal Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hong Fan, Professor
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhigang Cai, Professor
Organizational Affiliation
The Second Hospital of Hebei Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xinri Zhang, Professor
Organizational Affiliation
The First Affiliated Hospital of Shanxi Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xin Su, Professor
Organizational Affiliation
Nanjing General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojing Cui, MD
Phone
+86 10 84206269
Email
cuixiaojing86@163.com
First Name & Middle Initial & Last Name & Degree
Bin Cao, MD
Phone
+86 13911318339
Email
caobin_ben@163.com
Facility Name
Beijing Chaoyang Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing Hospital of TCM
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Beijing LuHe Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Fu Xing Hospital, Capital Medical Unviersity
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Chen, MD
Facility Name
The First Affiliated Hospital of Wenzhou University
City
Wenzhou
State/Province
Fujian
Country
China
Individual Site Status
Active, not recruiting
Facility Name
First Hospital of QinHuangDao
City
QinHuangDao
State/Province
Hebei
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Nanjing General Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of NanChang University
City
NanChang
State/Province
Jiangxi
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Qingdao Municipal Hospital
City
Qingdao
State/Province
Shandong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The Central Hospital of ZiBo City
City
ZiBo
State/Province
Shandong
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Active, not recruiting
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The General Hospital of Tianjin Medical University
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia

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