Serum concentrations and concentrations in epithelial lining fluid of antibiotics under continious infusion - ATB Studie
- Conditions
- The CT will be carried out on an intensive care unit, including critical ill patients with severe infectious disease needing treatment with one or more antibiotics. These antibiotics are all administered by continuous infusion according to our clinical routine.
- Registration Number
- EUCTR2005-002128-32-DE
- Lead Sponsor
- Abteilung für Anaesthesiologie und Intensivmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Patients of both gender with a minimum of 18 years of age
Patients with one or more of the following severe infectious diseases:
sepsis, pneumonia, infections of different viscera
Minimum expected stay of 3 days on the ICU
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
Pregnant and nursing women
Contraindications or allergy against one of the antibiotic included in our trial
Known resistance of the pathogen
Every patient can be included only once into the CT
Every patient can only be integrate into one single CT, if he is already included in an other CT, he will be excluded.
Expected stay on the ICU less than 3 days, or expected death in the next 48 hours.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of the CT is to obtain pharmacokinetic data on the different antibiotics, especially the penetration of these antibiotics under continuous infusion into the infected viscera (in our CT: Epithelial lining fluid). Additionally quantitative microbiological investigations will be done in the epithelial lining fluid (ELF) and the results will be associated with the antibiotic concentration in ELF and blood.;Secondary Objective: Evaluation of the clinical tolerance of the continuous infused antibiotics and there therapeutic success.<br>Adaptation of the given dose of antibiotic / day<br><br>;Primary end point(s): Serum antibiotic concentration <br>Serum urea concentration on the 3rd or 4th day of treatment<br>Epithelial lining fluid antibiotic concentration on the 3rd or 4th day of treatment<br>Epithelial lining fluid urea concentration on the 3rd or 4th day of treatment<br>Microbiological quantitative data on the pathogen(s) on the 3rd or 4th day of treatment<br>
- Secondary Outcome Measures
Name Time Method