2022-502013-28-00
Recruiting
Phase 4
STRAtified Dosing based on Augmented renal clearance for CEFtriaxone in patients with severe community-acquired pneumonia: the STRADA-CEF trial
UZ Leuven, UZ Leuven6 sites in 1 country270 target enrollmentStarted: December 11, 2023Last updated:
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- UZ Leuven, UZ Leuven
- Enrollment
- 270
- Locations
- 6
- Primary Endpoint
- Intensive care unit (ICU) Length of Stay (LOS)
Overview
Brief Summary
The general objective of this project is to evaluate the clinical benefit and safety of stratified every 24-hour (q24h) vs. q12h 2g ceftriaxone therapy in critically ill patients with sCAP based on the risk for development of ARC.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to – or within 72 hours after oral consent prior to – any screening procedures
- •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.
- •Aged 18 years or older at the baseline visit
- •Confirmed diagnosis of sCAP, as defined by the current IDSA/ATS guideline
- •Ceftriaxone initiated for sCAP
- •(Planned) admission to an ICU ward
Exclusion Criteria
- •Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
- •Need for renal replacement therapy on the day of inclusion
- •Ceftriaxone treatment >12h before study enrolment
- •Patients with (suspicion of) meningitis, requiring treatment with ceftriaxone 2g q12h
- •Known hypersensitivity to beta-lactam antibiotics
- •Patients having received more than 1 amoxicillin-clavulanate dose since hospital admission
- •Patients expected to be discharged from the ICU within 48h
- •Patients expected to stop ceftriaxone therapy within 48h
- •Patients receiving palliative treatment under a “discontinue therapy" code
- •Previous enrolment in this study
Outcomes
Primary Outcomes
Intensive care unit (ICU) Length of Stay (LOS)
Intensive care unit (ICU) Length of Stay (LOS)
Secondary Outcomes
- Delta SOFA score
- ICU mortality
- 28-day mortality
- Hospital LOS
- Alive ICU free days at day 28
- Ventilator-free days at day 28
- Clinical cure at day 14
- Microbial eradication at day 14
- Emergence of resistance at day 14
- PK/PD target attainment
- Assessment of safety
- Procalcitonin and C-reactive protein concentrations
Investigators
Matthias Gijsen
Scientific
UZ Leuven
Study Sites (6)
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