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Clinical Trials/EUCTR2015-005349-29-HR
EUCTR2015-005349-29-HRActive, not recruitingPhase 1

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

Xellia d.o.o.0 sites16 target enrollmentStarted: April 28, 2016Last updated:
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
16

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Inclusion Criteria

  • -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

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.

Investigators

Sponsor
Xellia d.o.o.

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