carbapenem resistant Klebsiella pneumoninae blood stream infection
Conditions
Interventions
Low Dose:polymyxin B 1.25mg/kg q 12h, Loading dose 2.5mg/kg. meropenem 2g q6h, 3h prolonged infusion
High Dose:polymyxin B 1.5mg/kg q 12h, Loading dose 2.5mg/kg. meropenem 2g q6h, 3h prolonged infusion
Sponsors
Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. patients meet the clinical diagnose criteria of BSI and blood culture result is CRKP; 2. patient aged at least 18 years; 3. female patients at childbearing age have negative blood HCG test and agree to take contraception measures during the whole study period; 4. endogenous creatinine clearance rate is in the range of 60-120 mL/min; 5. agree to sign the informed and consent form by oneself or authorized agent.
Exclusion criteria
Exclusion criteria: 1. negative blood culture; 2. hemetopathy patients; 3. patients receives active antibiotics more than 48 hours in 72 hours before enrollment, unless clinical failure evidence exists; 4. sever consciousness failure (Glasgow score less than 8), or predict life time less than 1 month; 5. anaphylaxis history to polymyxin or meropenem; 6. patients participated in another clinical trial in 3 months 7. female patients in pregnancy or feeding; 8. patients unlikely to follow the study protocol; 9. investigator consider the enrollment will affect the safety of patient or quality of study data; 10. patients with history of epilepsy or myasthenia gravis; 11. no condition for blood sampling; 12. use or may use nephrotoxicity drug during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;28-day all cause mortality;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| nephrotoxicity;AE rate; | — |
Countries
China
Contacts
Public ContactYU, Yunsong
Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
Outcome results
None listed