Markers that indicate the drug concentration in the infection place in very ill patients
- Conditions
- All patients given standard of care intravenous therapy of the studied antibiotics will be screened against the inclusion criteria. Two groups are included: Group A (septic patients with organ dysfunction defined as SOFA >2) and Group B (control group of non-septic patients without organ dysfunction defined as SOFA <2). We will include 4 Group C healthy volunteers, which will receive both meropenem and linezolid.Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2021-004108-16-AT
- Lead Sponsor
- Medical University Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 64
Group A (septic patients with organ dysfunction defined as SOFA >2):
•= 18 years old
•SOFA >2 at study inclusion
•Therapy with one of the chosen antibiotics via continuous or intermittent dosing regimen (indication at the discretion of the treating physicians) for at least 2 days at time of inclusion.
•If possible written informed consent obtained from the patient.
•Retrospectively given signed and dated informed consent – patients may be unconscious during the study duration making prior approval impossible. However, as most of the procedures based on this study represents a therapeutic approach, except for the microdialysis and additional samples, informed consent of the patients will be inquired as soon as they regain the ability to fully understand the given information.
Group B (control group of non-septic patients without organ dysfunction defined as SOFA <2):
•= 18 years old
•SOFA <2 at study inclusion
•Therapy with one of the chosen antibiotics via continuous or intermittent dosing regimen (indication at the discretion of the treating physicians) for at least 2 days at time of inclusion.
•If possible, written informed consent obtained from the patient.
•Retrospectively given signed and dated informed consent – patients may be unconscious during the study duration making prior approval impossible. However, as most of the procedures based on this study represents a therapeutic approach, except for the microdialysis and additional samples, informed consent of the patients will be inquired as soon as they regain the ability to fully understand the given information.
Group C (control group of healthy volunteers)
•Healthy subjects aged 18 to 55
•Good state of health (mentally and physically)
•Body mass index within a range of 17.5 to 32 kg/m²
•No regular medication within the last 2 weeks prior to the first study day
•A signed and dated written informed consent form
•The subject is fully capable to understand and willingly to comply with the protocol requirements, timetables, instructions and protocol-stated restrictions
•Negative serology (human immunodeficiency virus, hepatitis Bs-Ag and C-Ab) at screening
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 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Group A and B:
•Known allergy or hypersensitivity against the study drug.
•Any disease (investigator´s judgement) considered relevant for the proper performance of the study (for example autoimmune diseases; severe systemic inflammation caused by other diseases; or chronic diseases requiring immunomodulation therapy).
•Requiring hemofiltration or hemodialysis.
•Pregnancy.
•Antibiotic cessation before the first blood sample collection.
•Non-stable dose for the previous 24 hours.
•Positive serology for hepatitis or HIV.
•Patients with thrombocytopenia associated with a significant risk of bleeding (< 50 G/L) or a disorder of plasmatic coagulation (DIC, factor deficiency)
•Any disease considered relevant for proper performance of the study, or risks to the patient, at the discretion of the investigator.
•Other factors that preclude study participation in the opinion of the investigator.
Group C:
•Pregnancy
•Women of childbearing potential and men who are not employing contraceptive measures or abstain from sexual contact until one week after the final examination
•Any acute or chronic illness or clinically relevant (Investigator’s judgement) abnormality identified on the screening medical assessment, laboratory tests or ECG, unless in the opinion of the Investigator it will not interfere with the study procedures, affect the outcome of the study or compromise the safety of the subject
•Laboratory or clinical signs of any clinically relevant coagulation disorder
•Any contraindication against administration of any active or inactive ingredients of the designated study medication including known allergic or anaphylactic reactions and history of hypersensitivity reactions
•Impaired renal function with a creatinine clearance of = 90 mL/min (Cockroft gault calculated)
•Ongoing smoking of greater than five cigarettes (or equivalent) per day.
•Alcohol abuse (more than 2 glasses of either a small beer, 1/8 L wine or 2 cL spirits per day)
•Drug abuse
•Participation in a trial with any drug within 30 days or five half-lives (whichever is longer) before the start of the study.
•Any other reason that the Investigator considers making the subject unsuitable to participate
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method