Study on the impact of precision dosing of vancomycin in adults

Phase 1

• Conditions: Gram positive infection; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2021-003670-31-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-09
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

- age: =18 years
- admitted to the participating ward units (non-critically ill patients)
- suspected or confirmed Gram positive infection
- planned to start or started on intravenous continuous infusion (CI) vancomycin treatment (if the patient was previously treated with vancomycin, the minimum interval to a previous vancomycin treatment episode is 48 hours)
- informed consent signed by the patient or legal representatives
- not previously enrolled in this trial
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 107
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 73

Exclusion Criteria

- extracorporeal treatment at inclusion (extracorporeal membrane oxygenation, dialysis, body cooling)
- serum creatinine level above 2.5 mg/dL at inclusion
- patient death is deemed imminent and inevitable

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified