Development of an optimized dosing regimen of ceftazidime-avibactam in critically ill patients treated with continuous renal replacement therapy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

4 May 2025 → ongoing

Decision date (initial)

2025-01-24

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

European Society of Clinical Microbiology and Infectious Diseases (ESCMID)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacokinetic

Document exposure and pharmacokinetics of ceftazidime-avibactam in critically ill patients with CRRT

Secondary objectives 2

1. Evaluate PK/PD target attainment
2. Perform dosing simulations in order to define an optimized dosing regimen

Conditions and MedDRA coding

Ceftazidime-avibactam therapy in critically ill patients undergoing continuous renal replacement therapy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 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.
2. 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.
3. Admission to the ICU ward
4. Aged 18 years or older
5. Receiving concomitant treatment with ceftazidime-avibactam and any form of continuous renal replacement therapy

Exclusion criteria 7

1. Participant has a history of allergic reactions to either ceftazidime or avibactam
2. Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
3. Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
4. Female who is pregnant or breast-feeding
5. No concomitant ceftazidime-avibactam and CRRT on day of inclusion
6. Receiving palliative treatment
7. Previous enrolment in this study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Pharmacokinetic parameters of ceftazidime and avibactam
2. PK/PD target attainment of ceftazidime and avibactam
3. Population PK model of ceftazidime-avibactam
4. Optimized ceftazidime-avibactam dosing regimen

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Dorian Vanneste

Public contact point

Organisation

UZ Leuven

Contact name

Dorian Vanneste

Locations

3 EU/EEA countries · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications