ZAVI APD ELF Protocol v2.2
Peritonitis, Pneumonia
About this trial
This is an interventional other trial for Peritonitis
Eligibility Criteria
Inclusion criteria (PART A - PATIENTS UNDERGOING APD):
- Males or females aged between 18 and 85 years undergoing automated peritoneal dialysis (APD)
- Written informed consent given after being provided detailed information about the nature, risks, and scope of the clinical study as well as the expected desirable and adverse effects of the drug
- No legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study
Exclusion criteria (PART A - PATIENTS UNDERGOING APD):
- Known allergy or hypersensitivity against study drug or other beta-lactam antibiotics
- History of severe allergic or anaphylactic reactions to any medication
- Any systemic infection
- Peritonitis or catheter-related infection which required antibiotic treatment within 2 months prior to the start of the study
- Pregancy or, in case of women of child-bearing potential, lack of willingness to apply adequate contraception measures during study period
- Haemoglobin below 9 g/dl
- Other objections to participate in the study in the opinion of the investigator
Inclusion criteria (PART B - CRITICALLY ILL PATIENTS):
- Age above 18 years
- Intubated patients admitted to an intensive care unit of the Vienna general hospital (AKH) participating in this study
- Sequential organ failure assessment (SOFA) score > 6 at study inclusion
- Clinical diagnosis of nosocomial pneumonia or VAP
- Body mass index (calculated from measured or estimated body weight and height) between 18 and 40
- Therapy with CAZ/AVI at a dosage of 2g/0.5g three times daily (indication at the discretion of the treating physicians)
Exclusion criteria (PART B - CRITICALLY ILL PATIENTS):
- Known allergy or hypersensitivity against study drug or other beta-lactam antibiotics
- Any disease considered relevant for proper performance of the study, or risks to the patient, at the discretion of the investigator
- Impaired renal function denoted by an estimated GFR of <50 mL/min according to Cockroft-Gault at study inclusion
- Requiring hemofiltration or hemodialysis
- Pregnancy
- Other factors that preclude study participation in the opinion of the investigator
Sites / Locations
- Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Other
Other
A - patients on automated peritoneal dialysis
B - critically ill patients with pneumonia
each of n=8 patients will receive one single intravenous infusion of ceftazidime/avibactam (CAZ/AVI) 2g/0.5g over two hours. Subsequently, PK of CAZ/AVI will be determined in plasma and peritoneal dialysis fluid (and urine, if applicable) at protocol-defined time points over 24 hours.
following one intravenous dose of 2g/0.5g CAZ/AVI (which patients will receive based on clinical indication by their treating physician), PK of CAZ/AVI will be determined at protocol-defined time points over one dosing interval in plasma and in epithelial lining fluid (ELF).