Adjunctive Therapy of Andrographolid Sulfonatein Community Acquired Pneumonia

Qingfeng Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Community Acquired Pneumonia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02913118

QF-CAP-20160402

Details and patient eligibility

About

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.

Enrollment: 462 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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462 participants in 2 patient groups, including a placebo group

standard antibiotic treatment +AS injection

Experimental group

Description:

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

Treatment:

Drug: Azithromycin, Minocycline or Doxycycline

Drug: Amoxicillin-clavulantic acid

Drug: Fluoroquinolones

Drug: Cephalosporin

Drug: Andrographolid Sulfonate Injection (AS Injection)

standard antibiotic treatment + AS placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Azithromycin, Minocycline or Doxycycline

Drug: Amoxicillin-clavulantic acid

Drug: Placebo

Drug: Fluoroquinolones

Drug: Cephalosporin