CRE and CRAB lower respiratory tract infections
Conditions
Interventions
First phase:Patients received 200mg loading dose of tigecycline as a 120-min i.v. infusion followed by 100mg as 60-min i.v. infusions every 12h (q12h)
Second phase:Patients were treated with tigecycline 200mg as 120-min i.v. infusions every 24h (q24h)
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Hospitalized male or female,aged 18 years or older; 2. Patients with a definitive diagnosis of lower respiratory tract infections caused by CRE or CRAB based on the results of bacterial culture in vitro; 3. Tigecycline is needed for anti-infective treatment according to the results of drug-sensitive test; 4. Weighing between 45 and 90 kilograms; 5. Willing to join the study by signing a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known or suspected Pseudomonas aeruginosa concurrent infection; 2. Use of glucocorticoids or immunosuppressive agents, or immunosuppressed and immunodeficient individuals such as HIV infected patients; 3. Patients with life-threatening diseases such as acute congestive heart failure (CHF), acute coronary syndrome (ACS) and unstable arrhythmia; 4. Patients with persistent shock; 5. Patients with Child Pugh C chronic liver diseases, or abnormal liver function,transaminases (AST and/or ALT)>2×upper limit of normal,and/or total bilirubin (TBIL)>1.5×upper limit of normal; 6. Patients with moderate to severe impairment of renal function (CLCR<50mL/min); 7. Known or suspected hypersensitivity to tigecycline or tetracyclines; 8. Patients who are moribund with expected survival time less than the treatment cycle; 9. Pregnant or lactating women; 10. Patients with any concomitant disease that, as judged by study physician,will substantially increase the risk associated with the patients' participation in and/or completion of the study, or make it unlikely that the contemplated course of therapy will be completed; 11. Concomitant use of any other experimental drugs or participation in other clinical trials within 6 months before the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of tigecycline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Microbiology analysis;Clinical effect of tigecycline;Safety evaluation; | — |
Countries
China
Contacts
Public ContactChao Zhang
Peking University Third Hospital
Outcome results
None listed