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
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.
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.
Browse Pneumonia studies →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.
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)
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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:
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
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
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
time to clinical stability
Time frame: 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
Time frame: 14 days
the duration of fever
Time frame: 14 days
the initial treatment failure rate
Time frame: 14 days
length of stay in hospital
Time frame: 14 days
questionnaire for hospitalization expenses
Time frame: 14 days
the duration of intravenous antibiotic treatment
Time frame: 14 days
the rate of diarrhea and intestinal dysbacteriosis
Time frame: 14 days
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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