Rapid Oral Switch in Infectious Endocarditis, the ROSIE trial

Conditions

Infective Endocarditis

Brief summary

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

Detailed description

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.

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGGentamycine B. Braun 1 mg/ml solution pour perfusion

DRUGAmoclaneEG 875 mg/125 mg Filmtabletten

DRUGAmoxicillin AB 1000 mg dispergeerbare tabletten

DRUGCefazoline Sandoz 1 g poeder voor oplossing voor injectie

DRUGFloxapen

DRUGpoeder voor oplossing voor injectie 1 g

DRUGEUSAPRIM Forte 160 mg/800 mg tabletten

DRUGAvelox 400 mg Filmtabletten

DRUGClindamycin Sandoz 300 mg harde capsules

DRUGDelamoxyle 1 g

DRUGpoudre pour solution injectable/pour perfusion

DRUGCeftriaxone Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusie

DRUGRifadine 300 mg capsules

DRUGhard

DRUGLevofloxacine EG 500 mg comprimés pelliculés

DRUGPenicilline 1.000.000 IE

DRUGpoeder voor oplossing voor injectie

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Outcome results

None listed