Community-acquired Bacterial Pneumonia
Conditions
Interventions
Group 1 :Elacycline 1.0 mg/kg IV q 12 h
Group 2:Two doses of eracycline 1.5 mg/kg IV were administered 12 hours apart (q12h). From the second day to the end of treatment (the third dose to the final dose), elacycline was 1.5 mg/kg, q24h
Group 3:Elacycline (dose and frequency determined in Stage 1)
Group 4:Moxifloxacin 0.4 g IV q24h
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 to 80 years (inclusive); 2. A CABP that meets the following criteria: (1) Acute disease (duration = 0.5 µg/L, or immature neutrophils > 15%; (3) The imaging examination is consistent with the manifestations of bacterial pneumonia; 3. PSI (PORT) grade II combined with type I respiratory failure, or PSI (PORT) >= grade III.
Exclusion criteria
Exclusion criteria: 1. Need to receive ICU treatment and/or mechanical ventilation treatment; 2. Meet the diagnostic criteria for septic shock; 3. Diagnosed or suspected of any of the following conditions: (1) Ventilator-associated pneumonia or hospital-acquired pneumonia; (2) Aspiration pneumonia; (3) Viral pneumonia; (4) Primary or metastatic lung cancer; (5) Known or suspected active pulmonary tuberculosis; (6) Pneumocystis pneumonia; 4. Clear culture results show that the CABP pathogen is not sensitive to the test drug; 5. During the screening, it is clear that other systemic antibacterial, antifungal or antiviral drug therapy is needed during the study period; 6. It is estimated that the antibacterial drug treatment for this pneumonia may exceed 14 days; 7. Lung infiltration caused by non-infectious causes; 8. Basic diseases of the respiratory system lead to structural lung damage, or chronic neurological diseases that hinder the clearance of pulmonary secretions; 9. Lung abscess and empyema (excluding non-suppurative parapneumonic pleural effusion); 10. Accepting effective antibacterial drugs against CABP within 72 hours before randomization needs to be excluded, except for the following cases: (1) Subjects who only received antimicrobial therapy for 5 x ULN; (2) Total bilirubin > 3 x ULN; (3) AST or ALT > 3 x ULN, and total bilirubin > 2 x ULN; 13. Existing immunocompromised diseases or clinical conditions; 14. Suffering from systemic malignant tumor diseases and need chemotherapy, immunotherapy, radiotherapy or anti-tumor treatment within the past 3 months or before TOC visit; 15. Life expectancy 450 ms during screening, uncorrected clinically significant hypokalemia at screening, clinically significant bradycardia, clinically significant heart failure with reduced left ventricular ejection fraction; symptomatic arrhythmia in the past; or other drugs that can prolong the QT interval during the expected study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Microbiological efficiency;Pharmacokinetics; | — |
Countries
China
Contacts
Public ContactLi Wanbo
Yunji Huamei Pharmaceutical (Beijing) Co., Ltd.
Outcome results
None listed