Community-acquired bacterial pneumonia
Conditions
Interventions
test group:Intravenous infusion of Ceftriamidine Sodium
control group:Intravenous infusion of Cefathiamidine
Sponsors
Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Men or women aged 18 to 75 years (including the cutoff) with a weight of at least 45 kg and a BMI of 18 to 30 kg/m2 (including the cutoff). 2) Community acquired bacterial pneumonia was diagnosed ? Clinical criteria (those with 3 or more of the following clinical symptoms, signs, and laboratory tests) are: a) cough or cough worsens; b) purulent sputum; c) Chest pain; d) difficulty or shortness of breath; e) signs of lung consolidation (e.g. percussion dullness, auscultation bronchial breathing sounds and/or moist rales); f) fever (armpit temperature =37.5 ° C, oral temperature =38.0 ° C or ear temperature =38.5 ° C) or hypothermia (=35 ° C); g) an increase or decrease in the total number of white blood cells in peripheral blood images, or an increase in the percentage of neutrophils or an increase in immature neutrophils (rods); h) hypoxemia. ? Imaging criteria: The chest imaging examination within 48 hours before inclusion showed new infiltrating shadow, which was distributed in single or multiple lobes, and the imaging report was issued by qualified imaging department personnel. ? Microbiological standards: sufficient qualified sputum or respiratory secretion specimens can be collected and sent to the laboratory for gram staining smear microscopy and bacterial culture (qualified sputum specimens are when squamous epithelial cells 25/ low-power field of vision). 3) The prognostic Panel score (PORT/PSI) risk score of the subjects during screening was grade II-IV, of which grade III or higher accounted for more than 75% of the total. 4) Sign the informed consent and be willing and able to follow the test procedures stipulated in the scheme. 5) The subjects (including their partners) had no pregnancy plan from two weeks before screening to three months after the last study administration, and voluntarily adopted effective, non-drug contraception and had no sperm or egg donation plan; Or the subject is infertile (surgically sterilized or menopausal).
Exclusion criteria
Exclusion criteria: 1) Suspected non-community-acquired bacterial pneumonia, such as ventilator-associated pneumonia, hospital-acquired pneumonia, aspiration pneumonia, pneumospora pneumonia, mycotic pneumonia, viral pneumonia, mycobacterium pulmonary infection, and known or suspected active pulmonary tuberculosis. 2) Pulmonary infiltration caused by non-infectious factors (e.g., pulmonary embolism, aspiration chemical pneumonia, hypersensitivity pneumonia, bronchial obstruction or obstructive pneumonia, primary or metastatic pulmonary malignancy, cystic pulmonary fibrosis, bronchiectasis). 3) Patients who need invasive mechanical ventilation therapy. 4) People who may need to be treated with other systemic antibiotics. 5) Septic shock must use vasoconstrictor. 6) PORT/PSI Level V or need to be admitted to intensive care unit. 7) Patients with pleural pus or pleural effusion, who are assessed by the investigator to require pleural aspiration. 8) Received ß-lactam drugs such as cephalosporins, penicillins and carbapenems within 7 days before enrollment. 9) Patients who received > 24 hours of antibacterials within 72 hours before enrollment, but whose symptoms and signs did not improve or worsen after receiving > 48 hours of antibacterials, except for clear clinical evidence that their treatment failed (patients who received CABP before enrollment should not exceed 25%). 10) Patients with a known history of ß-lactam drug allergy (such as cephalosporins, penicillin and other drugs), allergic asthma, anaphylactic shock and other severe allergic history are not eligible to participate in this clinical trial after being fully evaluated by researchers. 11) Severe renal impairment, defined as creatinine clearance (CrCl) =60 mL/min as calculated by the Cockcroft-Gault formula. 12) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (ULN), or total bilirubin > 3 times ULN, or AST or ALT > 3 times ULN and total bilirubin > 2 times ULN. 13) Neutropenia (neutrophils < 1.0×109/L) or thrombocytopenia (platelets < 80×109/L). 14) Patients with acute hepatitis, cirrhosis or advanced clinical manifestations of liver disease, such as ascites or hepatic encephalopathy. 15) People with serious neurological or mental diseases in the past or simultaneously. 16) Those who have cardiovascular disease or unstable angina pectoris rated =3 by the New York College of Cardiology (NYHA) or severe arrhythmia requiring medical treatment. 17) Patients with prior or concurrent malignant tumors who are not eligible to participate in this clinical trial after full evaluation by the investigator (except those with skin basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ that have been fully treated and cured for more than 5 years). 18) Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV-DNA) positive quantitative test; Hepatitis C virus antibody (HCV) positive and hepatitis C virus ribonucleic acid (HCV-RNA) positive test; Positive for human immunodeficiency virus (HIV) antibodies; Treponema pallidum antibody positive. 19) Patients with abnormal coagulation function and clinical significance, or risk of bleeding, as judged by researchers. 20) Patients who are or will be taking a steroid medication for a long period (more than 2 weeks) at a dose of at least 20 mg prednisone per day, or an equivalent dose of another glucocorticoid; Have received an organ transplant or bone marrow tr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic evaluation index;PPK index;PK/PD indicator; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation index of curative effect;Security assessment; | — |
Countries
China
Contacts
Public ContactPinHua Pan
Xiangya Hospital Central South University
Outcome results
None listed