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.
Conditions
Interventions
Trade Name: FORTUM® 2,0 g (Ceftazidim)
Product Name: Fortum
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ceftazidim
Other descriptive name: Fortum 2,0 g
Concentrati
Sponsors
Abteilung für Anaesthesiologie und Intensivmedizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Adaptation of the given dose of antibiotic / day ;Primary end point(s): Serum antibiotic concentration Serum urea concentration on the 3rd or 4th day of treatment Epithelial lining fluid antibiotic concentration on the 3rd or 4th day of treatment Epithelial lining fluid urea concentration on the 3rd or 4th day of treatment Microbiological quantitative data on the pathogen(s) on the 3rd or 4th day of treatment | — |
Countries
Germany
Outcome results
None listed