Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia

Community Acquired Pneumonia Clinical Trial

Official title:

Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia: A Multicenter Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02913118
• Other study ID #: QF-CAP-20160402
• Status: Recruiting
• Phase: Phase 4
• First received: September 12, 2016
• Last updated: April 9, 2018
• Start date: July 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: April 2018
• Source: Qingfeng Pharmaceutical Group
• Contact: Chen Wang, Professor
• Phone: +86 13901122992
• Email: cyh-birm[@]263.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 462
• Est. completion date: June 30, 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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:?the need for invasive mechanical ventilation?sepsis shock after active fluid resuscitation still need vasoactive drugs; Minor criteria:?respiratory rate >30 breaths/min, ?PaO2/FiO2=250mmHg(1mmHg=0.133kPa), ?multilobar infiltrates, ?confusion or/andunorientation, ?bloodurea nitrogen level=20mg/dl(7.14mmol/L), ?systolic 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.

Related Conditions & MeSH terms

• Community Acquired Pneumonia
• Pneumonia

Intervention

Drug:
• Andrographolid Sulfonate Injection (AS Injection)

• Cephalosporin

• Azithromycin, Minocycline or Doxycycline

• Amoxicillin-clavulantic acid

• Fluoroquinolones

• Placebo

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital	Beijing	Beijing
China	Beijing Hospital of TCM	Beijing	Beijing
China	Beijing LuHe Hospital, Capital Medical University	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Fu Xing Hospital, Capital Medical Unviersity	Beijing	Beijing
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of NanChang University	NanChang	Jiangxi
China	Nanjing General Hospital	Nanjing	Jiangsu
China	Qingdao Municipal Hospital	Qingdao	Shandong
China	First Hospital of QinHuangDao	QinHuangDao	Hebei
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	The General Hospital of Tianjin Medical University	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou University	Wenzhou	Fujian
China	The Central Hospital of ZiBo City	ZiBo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qingfeng Pharmaceutical Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to clinical stability		14 days
Primary	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	14 days
Secondary	the duration of fever		14 days
Secondary	the initial treatment failure rate		14 days
Secondary	length of stay in hospital		14 days
Secondary	questionnaire for hospitalization expenses		14 days
Secondary	the duration of intravenous antibiotic treatment		14 days
Secondary	the rate of diarrhea and intestinal dysbacteriosis		14 days