Target site pharmacokinetics of doripenem at steady state in intubated intensive care patients - Dori_MD_ICU

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000035-89-AT

Enrollment

Registered

2011-02-08

Start date

2011-02-16

Completion date

Unknown

Last updated

2021-06-21

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

Conditions

We will carry out the present study to determine concentrations of doripenem in plasma, in the interstitial space fluid of the subcutaneous and muscle tissue and ELF in 20 intubated intensive care patients who get doripenem for therapeutic or prophylactic reasons. Pharmacokinetic parameters will be calculated and used to determine pharmacokinetic/pharmacodynamic indices to estimate target site activity.

Interventions

Trade Name: Doribax Pharmaceutical Form: Concentrate for solution for infusion CAS Number: 364622-82-2 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 1500- INN or

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male or female , aged = 18 years • Doripenem for therapeutical or prophylactic reasons (this does not mean that doripenem is necessarily the only appropriate antibiotic in the respective condition) • Mechanical ventilaton via endotracheal tube 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: • Known allergy or hypersensitivity against study drug • Any disease considered relevant for proper performance of the study, or risks to the patient, at the discretion of the investigator

Design outcomes

Primary

Measure	Time frame
Main Objective: Determination of concentrations of doripenem at steady state in interstitial space fluid of subcutaneous fat, muscle tissue, and ELF in 20 intubated intensive care patients with prescribed doripenem for therapeutic or prophylactic reasons. Tissue and ELF concentrations will be related to corresponding unbound plasma concentrations. ;Secondary Objective: -;Primary end point(s): The time versus unbound doripenem concentration profiles in the interstitial space fluid of non-inflamed subcutaneous adipose tissue, muscle tissue, ELF, and in plasma will be determined.	—

Measure

Time frame

Main Objective: Determination of concentrations of doripenem at steady state in interstitial space fluid of subcutaneous fat, muscle tissue, and ELF in 20 intubated intensive care patients with prescribed doripenem for therapeutic or prophylactic reasons. Tissue and ELF concentrations will be related to corresponding unbound plasma concentrations. ;Secondary Objective: -;Primary end point(s): The time versus unbound doripenem concentration profiles in the interstitial space fluid of non-inflamed subcutaneous adipose tissue, muscle tissue, ELF, and in plasma will be determined.

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Countries

Austria

Outcome results

None listed

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