Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia

NCT02913118 | Unknown Phase 4 DMC

• 1 other identifier: QF-CAP-20160402
• Study Type: interventional
• Target: 462
• Locations: 1 country
• Sites: 16

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.

Conditions

Community Acquired Pneumonia

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• the duration of fever

  14 days

• the initial treatment failure rate

  14 days

• length of stay in hospital

  14 days

• questionnaire for hospitalization expenses

  14 days

• the duration of intravenous antibiotic treatment

  14 days

Study Arms (2)

standard antibiotic treatment +AS injection

EXPERIMENTAL

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

Drug: Andrographolid Sulfonate Injection (AS Injection); Drug: Cephalosporin; Drug: Azithromycin, Minocycline or Doxycycline; Drug: Amoxicillin-clavulantic acid; Drug: Fluoroquinolones

standard antibiotic treatment + AS placebo

PLACEBO COMPARATOR

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

Drug: Cephalosporin; Drug: Azithromycin, Minocycline or Doxycycline; Drug: Amoxicillin-clavulantic acid; Drug: Fluoroquinolones; Drug: Placebo

Interventions

Andrographolid Sulfonate Injection (AS Injection) DRUG

standard antibiotic treatment +AS injection

Cephalosporin DRUG

standard antibiotic treatment + AS placebo; standard antibiotic treatment +AS injection

Azithromycin, Minocycline or Doxycycline DRUG

standard antibiotic treatment + AS placebo; standard antibiotic treatment +AS injection

Amoxicillin-clavulantic acid DRUG

standard antibiotic treatment + AS placebo; standard antibiotic treatment +AS injection

Fluoroquinolones DRUG

standard antibiotic treatment + AS placebo; standard antibiotic treatment +AS injection

Placebo DRUG

standard antibiotic treatment + AS placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
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• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Qingfeng Pharmaceutical Group: lead

Study Sites (16)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, China

ACTIVE NOT RECRUITING

Beijing Hospital of TCM

Beijing, Beijing Municipality, China

ACTIVE NOT RECRUITING

Beijing LuHe Hospital, Capital Medical University

Beijing, Beijing Municipality, China

ACTIVE NOT RECRUITING

Fu Xing Hospital, Capital Medical Unviersity

Beijing, Beijing Municipality, China

RECRUITING

The First Affiliated Hospital of Wenzhou University

Wenzhou, Fujian, China

ACTIVE NOT RECRUITING

First Hospital of QinHuangDao

Qinhuangdao, Hebei, China

ACTIVE NOT RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

ACTIVE NOT RECRUITING

Nanjing General Hospital

Nanjing, Jiangsu, China

ACTIVE NOT RECRUITING

The First Affiliated Hospital of NanChang University

Nanchang, Jiangxi, China

ACTIVE NOT RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

ACTIVE NOT RECRUITING

Qingdao Municipal Hospital

Qingdao, Shandong, China

ACTIVE NOT RECRUITING

The Central Hospital of ZiBo City

Zibo, Shandong, China

ACTIVE NOT RECRUITING

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

ACTIVE NOT RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

ACTIVE NOT RECRUITING

The General Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

ACTIVE NOT RECRUITING

Related Publications (1)

• 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.

  PMID: 41489779 DERIVED

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Cephalosporins; Azithromycin; Minocycline; Doxycycline; Fluoroquinolones

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; 4-Quinolones; Quinolones; Quinolines

Study Officials

• Chen Wang, Professor

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

• Bin Cao, Professor

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

• 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

Central Study Contacts

Chen Wang, Professor

CONTACT

+86 13901122992; cyh-birm@263.net

Bin Cao, Professor

CONTACT

+86 13911318339; caobin_ben@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 23, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: June 30, 2019
• Last Updated: April 10, 2018

Record last verified: 2018-04

Locations

CN (16)