Measurement of levels of degradation product CDP-1 in patients with normal or impaired renal function who are treated with antibiotic vancomycin.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005349-29-HR

Enrollment

Registered

2016-04-28

Start date

2016-02-15

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Adimicin Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: VANCOMYCIN CAS Number: 1404-90-6 Trade

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To collect information on CDP-1 levels in plasma after repeated IV dosing of vancomycin in patients with normal and impaired kidney function, respectively. To explore if there is a difference in systemic exposure to CDP-1, relative to vancomycin, between patients with normal and impaired kidney function. ;Secondary Objective: not applicable; Primary end point(s): -CDP-1 load after IV dosing of vancomycin and CDP-1-to-vancomycin ratio in infusion solution. -PK parameters for vancomycin in patients with normal or impaired renal function, respectively, including AUCt, C max, tmax, C trough and CL from plasma. -PK parameters for CDP-1 in patients with normal or impaired renal function, respectively, including AUCt, C max, tmax, C trough and CL from plasma. -Dose-normalized CDP-1 AUCt in plasma in patients with normal or impaired renal function, respectively. -CDP-1 AUCt relative to vancomycin AUCt in plasma in patients with normal or impaired renal function, respectively. ; Timepoint(s) of evaluation of this end point: 9 or 10 Blood samples will be collected based on cohort ( 9 in patients with normal renal function; 10 in patients with impaired renal function): Pre- dose, during infusion (one hour after infusion start), 0 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 8 h, 12 h and 24 h. Each blood sample will be immediately centrifuged at 4 °C to obtain plasma. Plasma will be divided into 2 aliquots and stored at -20 °C or below until analysis.	—

Measure

Time frame

Main Objective: To collect information on CDP-1 levels in plasma after repeated IV dosing of vancomycin in patients with normal and impaired kidney function, respectively. To explore if there is a difference in systemic exposure to CDP-1, relative to vancomycin, between patients with normal and impaired kidney function. ;Secondary Objective: not applicable; Primary end point(s): -CDP-1 load after IV dosing of vancomycin and CDP-1-to-vancomycin ratio in infusion solution. -PK parameters for vancomycin in patients with normal or impaired renal function, respectively, including AUCt, C max, tmax, C trough and CL from plasma. -PK parameters for CDP-1 in patients with normal or impaired renal function, respectively, including AUCt, C max, tmax, C trough and CL from plasma. -Dose-normalized CDP-1 AUCt in plasma in patients with normal or impaired renal function, respectively. -CDP-1 AUCt relative to vancomycin AUCt in plasma in patients with normal or impaired renal function, respectively. ; Timepoint(s) of evaluation of this end point: 9 or 10 Blood samples will be collected based on cohort ( 9 in patients with normal renal function; 10 in patients with impaired renal function): Pre- dose, during infusion (one hour after infusion start), 0 h, 2 h, 2.5 h, 3 h, 4 h, 5 h, 8 h, 12 h and 24 h. Each blood sample will be immediately centrifuged at 4 °C to obtain plasma. Plasma will be divided into 2 aliquots and stored at -20 °C or below until analysis.

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Croatia

Contacts

Public ContactCT-point

Synovia Ltd

jacinta.vukovic@synovia-solutions.com38514819892

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026