ZAVI APD ELF Protocol v2.2

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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 peritoneal dialysis as well as on penetration of CAZ/AVI in ELF of critically ill patients. The present study is carried out to determine target site PK of CAZ/AVI in these two populations, in order to contribute to a more complete understanding of the drug's penetration to its site of action.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Markus Zeitlinger
• Treatments: Avibactam; Avibactam, ceftazidime drug combination; Ceftazidime

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