Clinical trial NCT02913118: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Community Acquired Pneumonia
Lead sponsor: Qingfeng Pharmaceutical Group
Sponsor class: INDUSTRY
First posted: 2016-09-23
Enrollment: 462
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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)

  1. Pneumonia that is acquired in community
  2. Symptoms and signs of pneumonia:

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  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.

Primary outcomes:
measure: time to clinical stability
timeFrame: 14 days
measure: number of study participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 14 days
Secondary outcomes:
measure: the duration of fever
timeFrame: 14 days
measure: the initial treatment failure rate
timeFrame: 14 days
measure: length of stay in hospital
timeFrame: 14 days
measure: questionnaire for hospitalization expenses
timeFrame: 14 days
measure: the duration of intravenous antibiotic treatment
timeFrame: 14 days
measure: the rate of diarrhea and intestinal dysbacteriosis
timeFrame: 14 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital of TCM
state: Beijing
city: Beijing
country: China
facility: Beijing LuHe Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Fu Xing Hospital, Capital Medical Unviersity
state: Beijing
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou University
state: Fujian
city: QinHuangDao
country: China
facility: First Hospital of QinHuangDao
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Nanjing
country: China
facility: Nanjing General Hospital
state: Jiangsu
city: NanChang
country: China
facility: The First Affiliated Hospital of NanChang University
state: Jiangxi
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: ZiBo
country: China
facility: The Central Hospital of ZiBo City
state: Shandong
city: Taiyuan
country: China
facility: The First Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: The General Hospital of Tianjin Medical University
state: Tianjin
Study officials:
affiliation: China-Japan Friendship Hospital
name: Chen Wang, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: China-Japan Friendship Hospital
name: Bin Cao, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Fu Xing Hospital, Capital Medical University
name: Jin Chen, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Hospital of TCM
name: Yuguang Wang, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Chao Yang Hospital
name: Li Gu, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Capital Medical University
name: Zhenyang Xu, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: First Hospital of China Medical University
name: Yan Yi, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Nanchang University
name: Wei Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: First Hospital of Qinhuangdao
name: Shufeng Xu, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Central Hospital of ZiBo City
name: Bo Liu, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin Medical University General Hospital
name: Jie Cao, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Wenzhou University
name: Yuping Li, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Qingdao Municipal Hospital
name: Xuedong Liu, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital
name: Hong Fan, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Hospital of Hebei Medical University
name: Zhigang Cai, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Shanxi Medical University
name: Xinri Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanjing General Hospital
name: Xin Su, Professor
role: PRINCIPAL_INVESTIGATOR
References: