severe community-acquired pneumonia
Conditions
Interventions
Experimental Group:Piperacillin tazobactam or meropenem combined with omacycline
Control Group:Piperacillin tazobactam or meropenem combined with moxifloxacin
Sponsors
The Fifth Medical Center of the PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-85 years. 2. Meet the SCAP diagnostic criteria of the 2019 IDSA guidelines. Key Criteria: (1) Respiratory failure requires mechanical ventilation; (2) Septic shock requires treatment with vasoactive drugs; Secondary criteria: (1) Respiratory rate>=30 beats/min; (2) Oxygenation index =20mg/dl; (6) Hypotension requiring active fluid resuscitation; (7) Body temperature < 36°C; (8) Leukocytes < 4,000/ml; (9) Platelet < 100,000/ml. SCAP can be diagnosed by meeting 1 major criterion or 3 or more minor criteria.
Exclusion criteria
Exclusion criteria: 1. Those who have been treated with quinolones or omalcycline for more than 3 days. 2. Those who are allergic to ß lactams, quinolones, and omacycline. 3. Patients with severe liver failure. 4. QT interval > 450 msec (males) or > 470 msec (females) at admission, or known long QT interval syndrome. 5. Severe immunosuppressive state: (1) primary immunodeficiency disease; (2) Active malignancy (excluding localized skin cancer or early cancer) within the year; (3) Receiving chemotherapy and radiotherapy treatment for tumors; (4) CD4 T lymphocyte count 600 mg prednisone (or equivalent) for 14 consecutive days; (7) Immunosuppressive drugs (cyclosporine, cyclophosphamide, hydroxychloroquine, methotrexate, azathioprine, tacrolimus, etc.) or bioimmunomodulators (such as biomodulatory monoclonal antibody therapy, etc.) in the past 3 months. 6. Suspect or confirm that the test drug is ineffective against pathogens that cause disease progression (such as Pneumocystis jirovecii, fungi, viruses, etc.). 7. Suspected or confirmed empyema (excluding parapneumonic pleural effusion) or lung abscess. 8. Hospitalization in other health care institutions (units) for more than 48 hours before admission. 9. Pregnant or lactating women. 10. The patient is expected to be unable to complete the treatment plan due to personal reasons. 11. Severe structural lung disease. 12. Patients with etiological evidence of Pseudomonas aeruginosa or Staphylococcus aureus in the past 1 year. 13. Those who refuse to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early treatment response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of treatment endpoint;Post-treatment evaluation;Safety evaluation;28-day survival situation; | — |
Countries
China
Contacts
Public ContactXin Zhang
The Fifth Medical Center of the PLA General Hospital
Outcome results
None listed