Plasma levels of crystalline degradation product 1 (CDP-1) in vancomycin- treated patients with normal or impaired renal function

Xellia d.o.o.0 个研究点目标入组 16 人开始时间: 2016年4月28日最近更新: 2019年6月30日

试验速览

暂无简介。

•-Male or female 18 years of age or older
•-creatinine clearance =90 mL/min (estimated using Cockroft-Gault formula),
•-treated with 1 g vancomycin q12h for at least 3 days,
•-provided informed consent.
•-Male or female 18 years of age or older
•-creatinine clearance <50 mL/min. (estimated using the Cockroft-Gault formula),
•-not in need of continuous hemofiltration,
•-treated with vancomycin q24h for at least 5 days at a dose which in the Investigator’s opinion corresponds to a dose of 2 g/day in patients with normal renal function,
•-provided informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 6

•Patients meeting ANY of the following criteria shall not be included into the study.
•1. Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection, as evidenced by medical history or positive result of serological testing.
•2. Pregnancy, if evident from medical history.
•3. Class II or III obesity (BMI =35).
•4. Treatment with medications which interfere with serum creatinine assay (e.g., barbiturates, cefazolin, ceforanide, cefoxitin, cefpirome, levodopa, methyldopa), or decrease CLCR without effect on glomerular filtration rate (cimetidine, pyrimethamine, trimethoprim) within 1 week prior to screening or during the screening period.
•5. Presence of risk factors which in the Investigator’s opinion may preclude completion of blood sampling according to this protocol.

发起方

Xellia d.o.o.