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Status unknownNCT02913118Updated Apr 10, 2018

Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia

A Phase 4 interventional study of Andrographolid Sulfonate Injection (AS Injection) and Cephalosporin in Community Acquired Pneumonia, sponsored by Qingfeng Pharmaceutical Group. Status unknown at 16 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-04-10.

Sponsored by Qingfeng Pharmaceutical Group · Phase 4, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
462
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Community Acquired Pneumonia

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03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 462 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.

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Lead sponsor

This is the only study on the registry with Qingfeng Pharmaceutical Group as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
462 participants (estimated)

Study arms

  • Experimental
    standard antibiotic treatment +AS injection

    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

  • Placebo comparator
    standard antibiotic treatment + AS placebo

    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

  • DrugAndrographolid Sulfonate Injection (AS Injection)
  • DrugCephalosporin
  • DrugAzithromycin, Minocycline or Doxycycline
  • DrugAmoxicillin-clavulantic acid
  • DrugFluoroquinolones
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. time to clinical stability

    Time frame: 14 days

  2. 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

    Time frame: 14 days

Secondary outcomes

  1. the duration of fever

    Time frame: 14 days

  2. the initial treatment failure rate

    Time frame: 14 days

  3. length of stay in hospital

    Time frame: 14 days

  4. questionnaire for hospitalization expenses

    Time frame: 14 days

  5. the duration of intravenous antibiotic treatment

    Time frame: 14 days

  6. the rate of diarrhea and intestinal dysbacteriosis

    Time frame: 14 days

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Study locations

2 of 16 sites recruiting
  • China-Japan Friendship Hospital
    Beijing, Beijing 100029, China
    Recruiting
  • Beijing Chaoyang Hospital
    Beijing, Beijing, China
    Active, not recruiting
  • Beijing Hospital of TCM
    Beijing, Beijing, China
    Active, not recruiting
  • Beijing LuHe Hospital, Capital Medical University
    Beijing, Beijing, China
    Active, not recruiting
  • Fu Xing Hospital, Capital Medical Unviersity
    Beijing, Beijing, China
    • Jin Chen, MD · Contact
    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, China
    Active, not recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02913118
Lead sponsor
Qingfeng Pharmaceutical Group
Responsible party
Sponsor
First posted
Sep 23, 2016
Start date
Jul 2016
Primary completion
Jan 2019 (estimated)
Completion
Jun 30, 2019 (estimated)
Last update
Apr 10, 2018

Study contacts

Chen Wang, Professor
Contact
cyh-birm@263.net
+86 13901122992
Bin Cao, Professor
Contact
caobin_ben@163.com
+86 13911318339
Chen Wang, Professor
principal investigator · China-Japan Friendship Hospital
Bin Cao, Professor
principal investigator · China-Japan Friendship Hospital
Jin Chen, Professor
principal investigator · Fu Xing Hospital, Capital Medical University
Yuguang Wang, Professor
principal investigator · Beijing Hospital of TCM
Li Gu, Professor
principal investigator · Beijing Chao Yang Hospital
Zhenyang Xu, Professor
principal investigator · Capital Medical University
Yan Yi, Professor
principal investigator · First Hospital of China Medical University
Wei Zhang, Professor
principal investigator · The First Affiliated Hospital of Nanchang University
Shufeng Xu, Professor
principal investigator · First Hospital of Qinhuangdao
Bo Liu, Professor
principal investigator · The Central Hospital of ZiBo City
Jie Cao, Professor
principal investigator · The General Hospital of TianJin Medical University
Yuping Li, Professor
principal investigator · The First Affiliated Hospital of Wenzhou University
Xuedong Liu, Professor
principal investigator · Qingdao Municipal Hospital
Hong Fan, Professor
principal investigator · West China Hospital
Zhigang Cai, Professor
principal investigator · The Second Hospital of Hebei Medical University
Xinri Zhang, Professor
principal investigator · The First Affiliated Hospital of Shanxi Medical University
Xin Su, Professor
principal investigator · Nanjing General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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