Pharmacokinetics of ertapenem in a three-weekly dosing regime in patients with end stage renal disease depending on hemodialysis

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-020492-23-NL

Enrollment

Registered

2010-06-07

Start date

2010-10-21

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Infection (bacterial)

Interventions

Trade Name: Invanz Pharmaceutical Form: Concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Hemodialysis patient - Threatment with ertapenem 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Age < 18 - Liverdisease - Alcoholabuse - Allergy for carbapenems - Diarrhoea - Use of valproicacid, probenicid - Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether Ertapenem reaches adequate through levels in a dosageregime of three administrations per week after hemodialysis in patients with end stage renal disease depending on hemodialysis. ;Secondary Objective: Clinical improvement of the infection after theatment with Ertapenem Pharmacokinetic model of Ertapenem in hemodialysis patients;Primary end point(s): Adequate throughlevels of Ertapenem	—

Measure

Time frame

Main Objective: To investigate whether Ertapenem reaches adequate through levels in a dosageregime of three administrations per week after hemodialysis in patients with end stage renal disease depending on hemodialysis. ;Secondary Objective: Clinical improvement of the infection after theatment with Ertapenem Pharmacokinetic model of Ertapenem in hemodialysis patients;Primary end point(s): Adequate throughlevels of Ertapenem

—

Countries

Netherlands

Outcome results

None listed

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