complicated skin and soft tissue infection or pulmonary infection
Conditions
Interventions
Contezolid group:Oral administration of 800mg of Contezolid Tablets, q12h, 7-14d
pulmonary infection patients:None
Sponsors
the First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
60 Years to 100 Years
Inclusion criteria
Inclusion criteria: (1) Any gender or weight, age = 60. (2) According to the clinical symptoms, signs, laboratory examination and imaging examination, it is diagnosed as complicated skin and soft tissue infection or HAP or VAP. The skin and soft tissue infection is classified on the basis of Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. And HAP and VAP are diagnosed on the basis of Diagnosis and Treatment Guidelines for Chinese Adult Hospital Acquired Pneumonia and Ventilator Associated Pneumonia (2018 Edition). (3) The gram-positive bacterial infections is judged according to clinical microbiology diagnosis or comprehensive clinical evaluation. (4) According to the overall evaluation of the researchers, patients who have already used commonly used anti Gram positive bacteria drugs have poor efficacy or have a higher risk of using commonly used anti Gram positive bacteria drugs, such as thrombocytopenia(PLT7.5 mg/L or acute kidney injury (the elevated value of blood creatinine >0.3mg/dL within 48h, the elevated value of blood creatinine is 1.5 times greater than the baseline value within 7d or urinary volume <0.5ml/kg * h and lasting for more than 6 hours) (5) If other anti Gram negative bacilli drugs are used in combination, which should be evaluated by the researcher and will not affect the efficacy of the experimental drug, they can also be enrolled. (6) The subjects, their legal representatives or their legal guardians understand the research steps and content, sign an informed consent form, and are willing to participate in this study.
Exclusion criteria
Exclusion criteria: (1) Subjects severely allergic to oxazolidinone drugs or have allergic constitution, such as allergic dermatitis and bronchial asthma. (2) Subjects have taken monoamine oxidase inhibitors within 2 weeks. (3) Subjects participated in other clinical studies within 3 months. (4) Researchers consider that subjects are not suitable for participating in this clinical study or it have an impact on endpoint evaluation due to various reasons.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics/Pharmacodynamics (PK/PD), the drug concentration in the patient's blood and bronchoalveolar lavage fluid;Effectiveness, including clinical efficacy and microbial efficacy; | — |
Primary
| Measure | Time frame |
|---|---|
| Safety, such as the occurrence of liver and kidney injury, bone marrow suppression, etc; | — |
Countries
China
Contacts
Public ContactZhou suming
Department of Geriatric ICU,the First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed