Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
152
Countries
1
Sites
1
Infective Endocarditis
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
Key facts
- Sponsor
- UZ Leuven
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Cardiovascular Diseases [C14], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
- Trial duration
- 30 Mar 2026 → ongoing
- Decision date (initial)
- 2026-02-06
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Pharmacodynamic, Therapy, Efficacy, Pharmacokinetic
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
Secondary objectives 3
- To assess the practical implementation of the protocol in a tertiary care centre in Belgium, including adherence, deviations, and barriers to uptake.
- To assess plasma antibiotic concentrations and target level attainment of oral antibiotics (as compared to literature), and their correlation with treatment outcomes
- To describe the impact of treatment strategies on hospital length of stay (HLOS), cost savings and patient-reported outcomes such as treatment adherence, satisfaction, and quality of life.
Conditions and MedDRA coding
Infective Endocarditis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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.
Exclusion criteria 8
- 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)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Primary: composite clinical success at 6 months, defined as the absence of all-cause mortality, unplanned cardiac surgery, embolic events, recurrent bacteremia
Secondary endpoints 5
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 7
Rifadine 300 mg capsules, hard
PRD586384 · Product
- Active substance
- Rifampicin
- Substance synonyms
- RIFAMPIN
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 450 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J04AB02 — RIFAMPICIN
- Marketing authorisation
- BE070917
- MA holder
- SANOFI BELGIUM
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
EUSAPRIM Forte 160 mg/800 mg tabletten
PRD12212275 · Product
- Active substance
- Sulfamethoxazole
- Substance synonyms
- SULFISOMEZOLE, SULPHAMETHOXAZOLE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 2880 mg milligram(s)
- Max total dose
- 9600 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01EE01 — SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Marketing authorisation
- BE109295
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Amoxicillin AB 1000 mg dispergeerbare tabletten
PRD7790778 · Product
- Active substance
- Amoxicillin
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL
- Max daily dose
- 4000 mg milligram(s)
- Max total dose
- 4000 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CA04 — AMOXICILLIN
- Marketing authorisation
- BE520746
- MA holder
- AUROBINDO N.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Clindamycin Sandoz 300 mg harde capsules
PRD11898695 · Product
- Active substance
- Clindamycin Hydrochloride
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 1800 mg milligram(s)
- Max total dose
- 1800 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01FF01 — CLINDAMYCIN
- Marketing authorisation
- BE381902
- MA holder
- SANDOZ N.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Levofloxacine EG 500 mg comprimés pelliculés
PRD12252172 · Product
- Active substance
- Levofloxacin
- Substance synonyms
- HR355
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01MA12 — LEVOFLOXACIN
- Marketing authorisation
- 2011110043
- MA holder
- EUROGENERICS N.V./S.A.
- MA country
- Luxembourg
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD6647620 · Product
- Active substance
- Moxifloxacin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01MA14 — MOXIFLOXACIN
- Marketing authorisation
- BE223203
- MA holder
- BAYER SA NV
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
AmoclaneEG 875 mg/125 mg Filmtabletten
PRD12264950 · Product
- Active substance
- Amoxicillin Trihydrate
- Substance synonyms
- AMOXYCILLIN TRIHYDRATE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 2625 mg milligram(s)
- Max total dose
- 875 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CR02 — AMOXICILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- BE225172
- MA holder
- EUROGENERICS N.V./S.A.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 6
Gentamycine B. Braun 1 mg/ml solution pour perfusion
PRD4429478 · Product
- Active substance
- Gentamicin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 3 mg/kg milligram(s)/kilogram
- Max total dose
- 3 mg/kg milligram(s)/kilogram
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01GB03 — GENTAMICIN
- Marketing authorisation
- BE333024
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Penicilline 1.000.000 IE, poeder voor oplossing voor injectie
PRD427365 · Product
- Active substance
- Benzylpenicillin Sodium
- Substance synonyms
- PENICILLIN G SODIUM, SODIUM PENICILLIN
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- IV INFUSION
- Max daily dose
- 24000000 IU international unit(s)
- Max total dose
- 4000000 IU international unit(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CE01 — BENZYLPENICILLIN
- Marketing authorisation
- BE101516
- MA holder
- CERES PHARMACEUTICALS NV
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cefazoline Sandoz 1 g poeder voor oplossing voor injectie
PRD845565 · Product
- Active substance
- Cefazolin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- IV INFUSION
- Max daily dose
- 6 g gram(s)
- Max total dose
- 3 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01DB04 — -
- Marketing authorisation
- BE217271
- MA holder
- SANDOZ N.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Delamoxyle 1 g, poudre pour solution injectable/pour perfusion
PRD11928935 · Product
- Active substance
- Amoxicillin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 12 g gram(s)
- Max total dose
- 12 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CA04 — AMOXICILLIN
- Marketing authorisation
- BE109417
- MA holder
- LABORATOIRES DELBERT
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Floxapen, poeder voor oplossing voor injectie 1 g
PRD10257479 · Product
- Active substance
- Flucloxacillin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 12 g gram(s)
- Max total dose
- 12 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CF05 — FLUCLOXACILLIN
- Marketing authorisation
- RVG 05990
- MA holder
- EUGIA PHARMA (MALTA) LTD
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ceftriaxone Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusie
PRD11944333 · Product
- Active substance
- Ceftriaxone Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 4 g gram(s)
- Max total dose
- 4 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01DD04 — -
- Marketing authorisation
- BE325735
- MA holder
- FRESENIUS KABI NV/SA
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UZ Leuven
- Sponsor organisation
- UZ Leuven
- Address
- Herestraat 49
- City
- Leuven
- Postcode
- 3000
- Country
- Belgium
Scientific contact point
- Organisation
- UZ Leuven
- Contact name
- studieverpleegkundige IAL
Public contact point
- Organisation
- UZ Leuven
- Contact name
- studieverpleegkundige IAL
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 152 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2026-03-30 | 2026-04-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 18 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 2025-524484-20 | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment arrangements 2025-524484-20 | 1 |
| Subject information and informed consent form (for publication) | L1 ICF Adults NL 2025-524484-20 | 1 |
| Subject information and informed consent form (for publication) | L2 Sponsorstatementmodel ICF_2025-524484-20 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Amoxicillin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Amoxicillin + clavulaanzuur BE225172 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Amoxicillin IV | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Avelox | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Cefazolin IV - BE217271 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Ceftriaxone IV | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Clindamycin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC flucloxacillin IV | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Gentamycine IV BE 333024 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Levofloxacin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Penicilline IV BE101516 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Rifampicin BE070917 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Trimethoprim sulfamethoxazol | 1 |
| Synopsis of the protocol (for publication) | D1 Protocol synopsis ENG 2025-524484-20 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-12 | Belgium | Acceptable 2026-02-06
|
2026-02-06 |