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Rapid Oral Switch in Infectious Endocarditis, the ROSIE study
EU CTIS ID: 2025-524484-20-00
What this study is testing
To prospectively evaluate whether a standardized local protocol for partial oral consolidation therapy in patients with infective endocarditis (IE) is non inferior, using a single arm, performance goal design
- 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 any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- 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.
- Definite native or prosthetic valve infective endocarditis according to the current diagnostic criteria (Fowler et al., 2023) (including clinical, microbiological, pathology and imaging criteria). In case of ‘possible IE’ according to the these criteria, cases will discussed within the multidisciplinary endocarditis team. If a decision to treat is made also a ‘possible’ case can be included.
- Admitted at UZ Leuven during the induction phase of treatment(less than 10 days of iv treatment)
- Causative organism identified as Streptococcus species, Enterococcus faecalis, Staphylococcus aureus, a coagulase negative staphylococcus or a gram negative micro-organism, susceptibility testing available or pending.
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
- Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
- Other causative micro organisme than noticed in inclusion criteria
- Extreme obesity (BMI of at least 40)
- Known non-adherence risk or inability to follow study procedures (e.g., due to cognitive impairment, active substance abuse)
- Pregnancy or breastfeeding
See the full eligibility criteria
Who can join
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- 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.
- Definite native or prosthetic valve infective endocarditis according to the current diagnostic criteria (Fowler et al., 2023) (including clinical, microbiological, pathology and imaging criteria). In case of ‘possible IE’ according to the these criteria, cases will discussed within the multidisciplinary endocarditis team. If a decision to treat is made also a ‘possible’ case can be included.
- Admitted at UZ Leuven during the induction phase of treatment(less than 10 days of iv treatment)
- Causative organism identified as Streptococcus species, Enterococcus faecalis, Staphylococcus aureus, a coagulase negative staphylococcus or a gram negative micro-organism, susceptibility testing available or pending.
What rules you out
- Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol
- Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial
- Other causative micro organisme than noticed in inclusion criteria
- Extreme obesity (BMI of at least 40)
- Known non-adherence risk or inability to follow study procedures (e.g., due to cognitive impairment, active substance abuse)
- Pregnancy or breastfeeding
- Participation in another interventional trial that may interfere with this study
- Any contra indication (according to the specific SmPC) for the proposed oral treatment; a.severe hypersensitivity reaction for the specific oral treatment b. in case of levofloxacin or moxifloxacin epilepsy, former tendinopathy due to fluorquinons, long QT or liver disease (childpugh C) c. in case of rifampin: liver disease (ALT/AST 5x > upper limit) d. in case of co-trimoxazole: kidney failure and oliguria (creatinine clearance < 15 ml/min)
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, 65+ years, 18-64 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.