Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

462 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Community Acquired Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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standard antibiotic treatment +AS injection

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

Group Type EXPERIMENTAL

Andrographolid Sulfonate Injection (AS Injection)

Intervention Type DRUG

Cephalosporin

Intervention Type DRUG

Azithromycin, Minocycline or Doxycycline

Intervention Type DRUG

Amoxicillin-clavulantic acid

Intervention Type DRUG

Fluoroquinolones

Intervention Type DRUG

standard antibiotic treatment + AS placebo

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

Group Type PLACEBO_COMPARATOR

Cephalosporin

Intervention Type DRUG

Azithromycin, Minocycline or Doxycycline

Intervention Type DRUG

Amoxicillin-clavulantic acid

Intervention Type DRUG

Fluoroquinolones

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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Andrographolid Sulfonate Injection (AS Injection)

Intervention Type DRUG

Cephalosporin

Intervention Type DRUG

Azithromycin, Minocycline or Doxycycline

Intervention Type DRUG

Amoxicillin-clavulantic acid

Intervention Type DRUG

Fluoroquinolones

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chen Wang, Professor

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Bin Cao, Professor

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Jin Chen, Professor

Role: PRINCIPAL_INVESTIGATOR

Fu Xing Hospital, Capital Medical University

Yuguang Wang, Professor

Role: PRINCIPAL_INVESTIGATOR

Beijing Hospital of TCM

Li Gu, Professor

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Zhenyang Xu, Professor

Role: PRINCIPAL_INVESTIGATOR

Capital Medical University

Yan Yi, Professor

Role: PRINCIPAL_INVESTIGATOR

First Hospital of China Medical University

Wei Zhang, Professor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Nanchang University

Shufeng Xu, Professor

Role: PRINCIPAL_INVESTIGATOR

First Hospital of Qinhuangdao

Bo Liu, Professor

Role: PRINCIPAL_INVESTIGATOR

The Central Hospital of ZiBo City

Jie Cao, Professor

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University General Hospital

Yuping Li, Professor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Wenzhou University

Xuedong Liu, Professor

Role: PRINCIPAL_INVESTIGATOR

Qingdao Municipal Hospital

Hong Fan, Professor

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Zhigang Cai, Professor

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Hebei Medical University

Xinri Zhang, Professor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Shanxi Medical University

Xin Su, Professor

Role: PRINCIPAL_INVESTIGATOR

Nanjing General Hospital

Locations

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China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING