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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.
Enrollment
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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)
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
Primary purpose
Allocation
Interventional model
Masking
462 participants in 2 patient groups, including a placebo group
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Central trial contact
Bin Cao, Professor; Chen Wang, Professor
Data sourced from clinicaltrials.gov
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