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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard antibiotic treatment +AS injection | Experimental | Andrographolid Sulfonate Injection (AS Injection) plus one of 3 antibiotics in China CAP Guideline |
|
| standard antibiotic treatment + AS placebo | Placebo Comparator | AS placebo (NS injection) plus one of 3 antibiotics in China CAP Guideline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Andrographolid Sulfonate Injection (AS Injection) | Drug |
| ||
| Cephalosporin |
| Measure | Description | Time Frame |
|---|---|---|
| time to clinical stability | 14 days | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| the duration of fever | 14 days | |
| the initial treatment failure rate | 14 days | |
| length of stay in hospital |
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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)
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:
Within 72 hours after symptom onset
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen Wang, Professor | Contact | +86 13901122992 | cyh-birm@263.net | |
| Bin Cao, Professor | Contact | +86 13911318339 | caobin_ben@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chen Wang, Professor | China-Japan Friendship Hospital | Principal Investigator |
| Bin Cao, Professor | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41489779 | Derived | Shang LH, Fan GH, Chen LP, Liu JH, Wang XG, Liu B, Tian GZ, Chen XS, Yu JX, Yang GR, Su X, Liu XD, Li YP, Xu SF, Lin YH, Cao J, Zhang W, Feng WS, Cai ZG, Wang QH, Wang JX, Wang YG, Chen J, Zhang YX, Cui XJ. Andrographolide Sulfonate Injection for Adjunctive Treatment of Non-severe Community-Acquired Pneumonia in Adults: A Multicenter, Double-Blind, Randomized Controlled Trial. Chin J Integr Med. 2026 Jan 5. doi: 10.1007/s11655-025-3932-8. Online ahead of print. |
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| Drug |
|
| Azithromycin, Minocycline or Doxycycline | Drug |
|
| Amoxicillin-clavulantic acid | Drug |
|
| Fluoroquinolones | Drug |
|
| Placebo | Drug |
|
| 14 days |
| questionnaire for hospitalization expenses | 14 days |
| the duration of intravenous antibiotic treatment | 14 days |
| the rate of diarrhea and intestinal dysbacteriosis | 14 days |
| 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 | 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 | Tianjin Medical University General Hospital | 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 | Principal Investigator |
| Beijing Chaoyang Hospital | Active, not recruiting | Beijing | Beijing Municipality | China |
| Beijing Hospital of TCM | Active, not recruiting | Beijing | Beijing Municipality | China |
| Beijing LuHe Hospital, Capital Medical University | Active, not recruiting | Beijing | Beijing Municipality | China |
| Fu Xing Hospital, Capital Medical Unviersity | Recruiting | Beijing | Beijing Municipality | China |
|
| The First Affiliated Hospital of Wenzhou University | Active, not recruiting | Wenzhou | Fujian | China |
| First Hospital of QinHuangDao | Active, not recruiting | Qinhuangdao | Hebei | China |
| The Second Hospital of Hebei Medical University | Active, not recruiting | Shijiazhuang | Hebei | China |
| Nanjing General Hospital | Active, not recruiting | Nanjing | Jiangsu | China |
| The First Affiliated Hospital of NanChang University | Active, not recruiting | Nanchang | Jiangxi | China |
| The First Hospital of China Medical University | Active, not recruiting | Shenyang | Liaoning | China |
| Qingdao Municipal Hospital | Active, not recruiting | Qingdao | Shandong | China |
| The Central Hospital of ZiBo City | Active, not recruiting | Zibo | Shandong | China |
| The First Hospital of Shanxi Medical University | Active, not recruiting | Taiyuan | Shanxi | China |
| West China Hospital, Sichuan University | Active, not recruiting | Chengdu | Sichuan | China |
| The General Hospital of Tianjin Medical University | Active, not recruiting | Tianjin | Tianjin Municipality | China |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D017963 | Azithromycin |
| D008911 | Minocycline |
| D004318 | Doxycycline |
| D024841 | Fluoroquinolones |
| ID | Term |
|---|---|
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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