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STRAtified Dosing based on Augmented renal clearance for CEFtriaxone in patients with severe community-acquired pneumonia: the STRADA-CEF trial
EU CTIS ID: 2022-502013-28-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
- Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive. A woman is considered of child-bearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- Mildly to moderately decreased eGFRCKD-EPI (<80 mL/min/1.73m²) at baseline (max. 1 year prior to hospital admission)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.