Infectious Disease
Conditions
Brief summary
Tigecycline is a last-resort antibiotic that is used to treat severe infections caused by extensively drug-resistant bacteria. However, the efficacy and safety data for tigecycline in infectious patients are lacking. The aim of this study is to assess the efficacy and safety of tigecycline in infectious patients using pharmacokinetics and omics.
Interventions
DRUGTigecycline
Efficacy and safety of Tigecycline
Sponsors
Shandong Provincial Hospital
Shandong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Inclusion criteria
* critically ill hospitalized males or nonpregnant females aged 18 years with severe infections which the treating clinician was treating with tigecycline
Exclusion criteria
1. severe liver dis- eases (e.g., Child-Pugh score C); 2. patients allergic to tetracycline and tigecycline; 3. those who have participated in other clinical trials, or those who are considered unsuitable by researchers; 4. pregnant women and lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Through study completion, an average of 15 days | Drug-related adverse events and serious adverse events |
| Pharmacokinetics of tigecycline | Through study completion, an average of 3 days | clearance in L/h |
| Rate constant for tigecycline distribution | Through study completion, an average of 3 days | Pharmacokinetics of tigecycline |
| The ratio of area under the concentration-time curve (AUC) to minimum inhibitory concentration (MIC). | Through study completion, an average of 3 days | PD target |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood platelet count | Through study completion, an average of 3 days | blood platelet count in ×10\^9/L |
| fibrinogen levels in mg/dL | Through study completion, an average of 3 days | — |
| thrombin time | Through study completion, an average of 3 days | thrombin time in second |
| prothrombin time | Through study completion, an average of 3 days | prothrombin time in second |
| activated partial thromboplastin time | Through study completion, an average of 3 days | activated partial thromboplastin time in second |
| international normalized ratio | Through study completion, an average of 3 days | international normalized ratio，INR |
Countries
China
Contacts
Primary ContactWei Zhao, Ph.D
Outcome results
None listed