SYFd16c035d7be9498d92f2bc884ae29c68Registry ID: 2025-524484-20-00|RecruitingPhase 4
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interventional
N/A
1 country
1
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 12, 2025
Actual (reported)Primary: composite clinical success at 6 months, defined as the absence of all-cause mortality, unplanned cardiac surgery, embolic events, recurrent bacteremia
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.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Gentamycine B. Braun 1 mg/ml solution pour perfusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry recordFormulated product
Rifadine 300 mg capsules, hard
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordFormulated product
Levofloxacine EG 500 mg comprimés pelliculés
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordFormulated product
Amoxicillin AB 1000 mg dispergeerbare tabletten
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
ORAL SOLUTION
View registry recordFormulated product
The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Gentamycine B. Braun 1 mg/ml solution pour perfusion
Named ingredient: Gentamicin
View registry recordRifadine 300 mg capsules, hard
Named ingredient: Rifampicin
View registry recordLevofloxacine EG 500 mg comprimés pelliculés
Named ingredient: Levofloxacin
View registry recordAmoxicillin AB 1000 mg dispergeerbare tabletten
Named ingredient: Amoxicillin
View registry recordCefazoline Sandoz 1 g poeder voor oplossing voor injectie
Named ingredient: Cefazolin sodium
View registry recordFloxapen, poeder voor oplossing voor injectie 1 g
Named ingredient: Flucloxacillin
View registry recordAvelox 400 mg Filmtabletten
UZ Leuven
Leuven, 3000, Belgium
studieverpleegkundige IAL
First Submitted
November 12, 2025
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
Cefazoline Sandoz 1 g poeder voor oplossing voor injectie
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
Formulated product
Floxapen, poeder voor oplossing voor injectie 1 g
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
Avelox 400 mg Filmtabletten
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordFormulated product
Delamoxyle 1 g, poudre pour solution injectable/pour perfusion
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION/INFUSION
View registry recordNamed ingredient: Moxifloxacin
Delamoxyle 1 g, poudre pour solution injectable/pour perfusion
Named ingredient: Amoxicillin
View registry recordContact the study team to confirm eligibility.