Clinical trial • Phase IV • Infectious Disease
Ceftazidime; Avibactam for Bacterial infection in critically ill patients undergoing continuous renal replacement therapy
Phase IV trial of Ceftazidime; Avibactam for Bacterial infection in critically ill patients undergoing continuous renal replacement therapy.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Bacterial infection in critically ill patients undergoing continuous renal replacement therapy
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 11-10-2024
- First CTIS Authorization Date
- 24-01-2025
Trial design
Phase IV trial in Belgium, Spain, Sweden.
- Target Sample Size
- 14
Eligibility
Recruits 14 Critically ill patients are included and the protocol allows consent to be provided by a legally authorized representative. The inclusion criteria state: "Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior – or within 72 hours after oral consent - to the initation of any study-specific procedures." No assent process for minors is described (study includes adults only, aged 18 years or older)..
- Pregnancy Exclusion
- Female who is pregnant or breast-feeding
- Vulnerable Population
- Critically ill patients are included and the protocol allows consent to be provided by a legally authorized representative. The inclusion criteria state: "Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior – or within 72 hours after oral consent - to the initation of any study-specific procedures." No assent process for minors is described (study includes adults only, aged 18 years or older).
Inclusion criteria
- {"criterion_text":"- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior – or within 72 hours after oral consent - to the initation of any study-specific procedures.\n- Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.\n- Admission to the ICU ward\n- Aged 18 years or older\n- Receiving concomitant treatment with ceftazidime-avibactam and any form of continuous renal replacement therapy"}
Exclusion criteria
- {"criterion_text":"- Participant has a history of allergic reactions to either ceftazidime or avibactam\n- Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol\n- Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial\n- Female who is pregnant or breast-feeding\n- No concomitant ceftazidime-avibactam and CRRT on day of inclusion\n- Receiving palliative treatment\n- Previous enrolment in this study."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Pharmacokinetic parameters of ceftazidime and avibactam","definition_or_measurement_approach":""}
- {"endpoint_text":"- PK/PD target attainment of ceftazidime and avibactam","definition_or_measurement_approach":""}
- {"endpoint_text":"- Population PK model of ceftazidime-avibactam","definition_or_measurement_approach":""}
- {"endpoint_text":"- Optimized ceftazidime-avibactam dosing regimen","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 14
- Recruitment Window Months
- 18
- Consent Approach
- Voluntary written informed consent of the participant or their legally authorized representative is required prior – or within 72 hours after oral consent - to the initiation of any study-specific procedures. Study includes adults (aged 18 years or older). Informed consent documents are available in multiple languages (documents listed include English, Français, Nederlands, Español, and Swedish subject information/ICF files). Consent by legally authorised representative is permitted when participant cannot provide consent.
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 14
Belgium
- Earliest CTIS Part Ii Submission Date
- 13-01-2025
- Latest Decision Or Authorization Date
- 24-01-2025
- Processing Time Days
- 11
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Centre Hospitalier Universitaire De Liege
- Department Name
- Intensive Care
- Contact Person Name
- Nathalie Layios
- Contact Person Email
- nathalie.layios@chuliege.be
- Site Name
- Hopital Erasme
- Department Name
- Internal medicine
- Contact Person Name
- Maya Hithes
- Contact Person Email
- maya.hites@hubruxelles.be
- Site Name
- UZ Leuven
- Department Name
- Intensive Care
- Contact Person Name
- Yves Debaveye
- Contact Person Email
- yves.debaveye@uzleuven.be
Spain
- Earliest CTIS Part Ii Submission Date
- 28-01-2025
- Latest Decision Or Authorization Date
- 04-02-2025
- Processing Time Days
- 7
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Hospital Del Mar
- Department Name
- Hospital Pharmacy
- Contact Person Name
- Sonia Luque
- Contact Person Email
- sluque@psmar.cat
Sweden
- Earliest CTIS Part Ii Submission Date
- 02-01-2025
- Latest Decision Or Authorization Date
- 28-01-2025
- Processing Time Days
- 26
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Uppsala University Hospital
- Department Name
- Infection
- Contact Person Name
- Thomas Tängdén
- Contact Person Email
- Thomas.Tangden@medsci.uu.se
Sponsor
Primary sponsor
- Full Name
- UZ Leuven
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Belgium
Third parties
- {"country":"","full_name":"European Society of Clinical Microbiology and Infectious Diseases (ESCMID)","duties_or_roles":"Monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- CEFTAZIDIME AND BETA-LACTAMASE INHIBITOR
- Active Substance
- Ceftazidime; Avibactam
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Authorised on the European market (product is marketed and SmPC provided)
- Maximum Dose
- 7.5 g per day
- Combination Treatment
- Yes
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