optimization of doses of broad spectrum B-lactames (ceftazidim and meropenem) and vancomycin in septic patient traeted with chronic hemodialysis.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001573-10-BE

Enrollment

Registered

2011-10-04

Start date

2012-01-24

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

hemodialysis oligoanuria sepsis MedDRA version: 14.0 Level: HLT Classification code 10040054 Term: Sepsis, bacteraemia, viraemia and fungaemia NEC System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: LLT Classification code 10066622 Term: Chronic hemodialysis System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Vancocin 500mg Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: VANCOMYCIN CAS Number: 1404-90-6 Concentration unit: mg milligram(s) Trade Name: glazidim 2 gr Ph

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -patient with a chronic renal failure and aligo-anuric in hemodialysis, hospitalised or not. -intravenous antibiotics traet gived to treat an infection. -patient receiving a combination of ceftazidim/vancomicyn or meropenem/vancomycin may be included. 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: -severe sepsis and sepsis shock -doses higher than recommanded antibiotics (traetment of meningitis...) -pregnant woman -age 30 kg/m²) or cachexic (BMI < 15 kg/m²) patient

Design outcomes

Primary

Measure	Time frame
Main Objective: interventional study of the pharmacocinetics of ceftazidim, meropenem and vancomycin in chronic hemodialysis patients tank to establish recommandations for doses of this antibiotics based on the evidence. ;Secondary Objective: ;Primary end point(s): define the pharmacokinetics of antibiotics examined in this study in patient treated with chronic hemodialysis.	—

Secondary

Measure	Time frame
Secondary end point(s): adjust the schedule of administration of antibiotics (B-lactams and vancomycin) for patient treated with chronic hemodialysis.	—

Countries

Belgium

Contacts

Public ContactPr. Frédérique Jacobs

Hôpital Erasme

frederique.jacobs@erasme.ulb.ac.be3225555680

Outcome results

None listed

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