Target site pharmacokinetics of doripenem at steady state in intubated intensive care patients - Dori_MD_IC
Phase 1
- 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.
- Registration Number
- EUCTR2011-000035-89-AT
- Lead Sponsor
- Med. Univ. Wien, Klinik für klinische Pharmakologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method