Status:
UNKNOWN
ZAVI APD ELF Protocol v2.2
Lead Sponsor:
Markus Zeitlinger
Conditions:
Peritonitis
Pneumonia
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief Summary
CAZ/AVI is a new antibiotic drug that is meant to be used for various indications including cIAI and nosocomial pneumonia. To date, limited data exists on PK of CAZ/AVI in patients undergoing peritone...
Detailed Description
Ceftazidime/Avibactam (CAZ/AVI) is a novel antibiotic drug that has recently become available. It consists of a β-lactam/β-lactamase fixed drug combination with an almost exclusively Gram-negative spe...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03790176
Start Date
October 1 2018
End Date
December 1 2022
Last Update
September 8 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of Vienna
Vienna, Austria, 1090