ZAVI APD ELF Protocol v2.2

NCT03790176 | Unknown Phase 1

• 1 other identifier: Version 2.2 April 19, 2018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Area under the concentration time curve (AUC) from 0 to 8 hours (AUC0-8)

  on study days

Study Arms (2)

A - patients on automated peritoneal dialysis

OTHER

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.

Drug: Intravenous Infusion

B - critically ill patients with pneumonia

OTHER

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).

Drug: Intravenous Infusion

Interventions

Intravenous Infusion DRUG

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

A - patients on automated peritoneal dialysis; B - critically ill patients with pneumonia

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Age above 18 years
• Intubated patients admitted to an intensive care unit of the Vienna general hospital (AKH) participating in this study
• 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)
• 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
• Requiring hemofiltration or hemodialysis

Sponsors & Collaborators

• Markus Zeitlinger: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Peritonitis; Pneumonia

Interventions

Infusions, Intravenous

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof. Priv. Doz. Dr.

Model Details: group A - patients on automated peritoneal dialysis group B - critically ill patients with pneumonia

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: December 31, 2018
• Study Start: October 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 8, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)