ZAVI APD ELF Protocol v2.2
NCT03790176 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2021-09-08
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.
Conditions
- Peritonitis
- Pneumonia
Interventions
- DRUG
-
Intravenous Infusion
see arm/group description. NO INTERVENTION IN STUDY GROUP B! PATIENTS OF GROUP B WILL RECEIVE CAZ/AVI INDEPENDENTLY FROM STUDY PARTICIPATION BASED ON DECISION OF THEIR TREATING PHYSICIAN
Sponsors & Collaborators
-
Markus Zeitlinger
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-01
- Primary Completion
- 2022-12-31
- Completion
- 2022-12-31
Countries
- Austria
Study Locations
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