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Clinical Trials in the EU / 2025-524484-20-00
Completed Phase IV

Rapid Oral Switch in Infectious Endocarditis, the ROSIE trial

2025-524484-20-00 · tracked via the Priya Life Science EU tracker
Sponsor
UZ Leuven
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Bacterial Infections and Mycoses
Decision date
06/02/2026
Enrollment target
152
Sites
Belgium

Condition studied

Infective Endocarditis

Investigational medicinal product(s)

Gentamycine B. Braun 1 mg/ml solution pour perfusionAmoclaneEG 875 mg/125 mg FilmtablettenAmoxicillin AB 1000 mg dispergeerbare tablettenCefazoline Sandoz 1 g poeder voor oplossing voor injectieFloxapenpoeder voor oplossing voor injectie 1 gEUSAPRIM Forte 160 mg/800 mg tablettenAvelox 400 mg FilmtablettenDelamoxyle 1 gpoudre pour solution injectable/pour perfusionCeftriaxone Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusieClindamycin Sandoz 300 mg harde capsulesRifadine 300 mg capsuleshardPenicilline 1.000.000 IEpoeder voor oplossing voor injectieLevofloxacine EG 500 mg comprimés pelliculés

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

Primary: composite clinical success at 6 months, defined as the absence of all-cause mortality, unplanned cardiac surgery, embolic events, recurrent bacteremia

Endpoint detail

Patient-reported satisfaction at completion of oral treatment., Complications (including antibiotic-related adverse events, treatment interruption/modification, non-adherence), during the entire treatment course., PK/PD target attainment of oral antibiotics, assessed per agent, based on predefined PK/PD thresholds at two time point during treatment., Length and cost of hospital stay, calculated from admission to discharge., Total duration of antibiotic therapy, calculated from treatment initiation until the final antibiotic dose administered for the same endocarditis episode.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-524484-20-00 on CTIS ↗ ← All trials in the EU