Measurement of levels of degradation product CDP-1 in patients with normal or impaired renal function who are treated with antibiotic vancomycin.
- Conditions
- Not applicable: medical conditions or diseases will not be investigated in this trial. In this trial pharmacokinetic parameters of vancomycin and its degradation products will be determined in blood plasma of patients treated with vancomycin and the differences in those parameters in patients with normal vs. patients with impaired renal function.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
- Registration Number
- EUCTR2015-005349-29-HR
- Lead Sponsor
- Xellia d.o.o.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 16
Cohort A:
-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.
Cohort B:
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method