Investigation of pharmacokinetics of Ciprofloxacin and Piperacillin/Tazobactam in Patients receiving continuous renal replacement therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021369-66-DE

Enrollment

Registered

2010-09-28

Start date

2010-11-16

Completion date

Unknown

Last updated

2014-01-27

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

Conditions

Sepsis and acute renal failure (ARF) are two pathological entities that commonly co-exist in patients admitted to intensive care. Antibiotic dosing in septic patients with ARF can be complicated and may result in either underdosing, causing treatment failure and antibiotic resistance, or overdosing resulting in drug toxicity. The aim of this study is to collect pharmacokinetic data for evaluating underdosing or overdosing of ciprofloxacin and piperacillin/tazobactam in RRT.

Interventions

Trade Name: Piperacillin / Tazobactam Stragen 4g/0,5g Product Name: Piperacillin / Tazobactam Stragen 4g/0,5g Pharmaceutical Form: CAS Number: 59703-84-3 Other descriptive name: PIPERACILLIN SODIUM C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Written consent to the clinical trial by the patient or the legal representative • Continuous renal replacement therapy • Antibiotic treatment with piperacillin/tazobactam and/or ciprofloxacin • Every patient has to be older than 18 years 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: • Unreadiness to the clinical trial • No antibiotic treatment with piperacillin/tazobactam and/or ciprofloxacin • No continuous renal replacement therapy • Not older than 18 years • Other clinical trial

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is to evaluate the practiced antibiotic dosing of ciprofloxacin and piperacillin/tazobactam in patients receiving continuous renal replacement therapy.;Secondary Objective: Secondary objective of the trial is to increase patient’s security by therapeutic drug monitoring.;Primary end point(s): • Collected blood-, dialysate- and urine- samples over 24 hours under continuous renal replacement therapy.	—

Measure

Time frame

Main Objective: The main objective of the trial is to evaluate the practiced antibiotic dosing of ciprofloxacin and piperacillin/tazobactam in patients receiving continuous renal replacement therapy.;Secondary Objective: Secondary objective of the trial is to increase patient’s security by therapeutic drug monitoring.;Primary end point(s): • Collected blood-, dialysate- and urine- samples over 24 hours under continuous renal replacement therapy.

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Countries

Germany

Outcome results

None listed

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