Clinical trial • Not applicable • Infectious Disease|Cardiology
GENTAMICIN for Infective Endocarditis
Not applicable trial of GENTAMICIN for Infective Endocarditis.
Overview
- Trial Therapeutic Area
- Infectious Disease|Cardiology
- Trial Disease
- Infective Endocarditis
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 12-11-2025
- First CTIS Authorization Date
- 06-02-2026
Trial design
open-label, comparator products listed in the application include: floxapen (flucloxacillin 1 g, intravenous), delamoxyle (amoxicillin 1 g iv), gentamycine b. braun (gentamicin 1 mg/ml solution for infusion, iv), penicilline 1.000.000 ie (powder for injection, iv infusion), ceftriaxone fresenius kabi (ceftriaxone 1 g iv), cefazoline sandoz (cefazolin 1 g iv infusion). (dose/schedule as per product marketing authorisation / smpcs provided.)-controlled Not applicable trial across 1 site in Belgium.
- Open Label
- Yes
- Comparator
- Comparator products listed in the application include: Floxapen (Flucloxacillin 1 g, intravenous), Delamoxyle (Amoxicillin 1 g IV), Gentamycine B. Braun (Gentamicin 1 mg/ml solution for infusion, IV), Penicilline 1.000.000 IE (powder for injection, IV infusion), Ceftriaxone Fresenius Kabi (Ceftriaxone 1 g IV), Cefazoline Sandoz (Cefazolin 1 g IV infusion). (Dose/schedule as per product marketing authorisation / SmPCs provided.)
- Target Sample Size
- 152
- Trial Duration For Participant
- 180
Eligibility
Recruits 152 No vulnerable populations selected; minimum age 18. "Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures". Assent not applicable..
- Pregnancy Exclusion
- Pregnancy or breastfeeding
- Vulnerable Population
- No vulnerable populations selected; minimum age 18. "Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures". Assent not applicable.
Inclusion criteria
- {"criterion_text":"- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures"}
- {"criterion_text":"- At least 18 years of age at the time of signing the Informed Consent Form (ICF)"}
- {"criterion_text":"- 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."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- Admitted at UZ Leuven during the induction phase of treatment(less than 10 days of iv treatment)"}
- {"criterion_text":"- 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
- {"criterion_text":"- Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol"}
- {"criterion_text":"- Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that would compromise the integrity of the Trial"}
- {"criterion_text":"- Other causative micro organisme than noticed in inclusion criteria"}
- {"criterion_text":"- Extreme obesity (BMI of at least 40)"}
- {"criterion_text":"- Known non-adherence risk or inability to follow study procedures (e.g., due to cognitive impairment, active substance abuse)"}
- {"criterion_text":"- Pregnancy or breastfeeding"}
- {"criterion_text":"- Participation in another interventional trial that may interfere with this study"}
- {"criterion_text":"- Any contra indication (according to the specific SmPC) for the proposed oral treatment; a.severe hypersensitivity reaction for the specific oral treatment b.\tin case of levofloxacin or moxifloxacin epilepsy, former tendinopathy due to fluorquinons, long QT or liver disease (childpugh C) c.\tin case of rifampin: liver disease (ALT/AST 5x > upper limit) d.\tin case of co-trimoxazole: kidney failure and oliguria (creatinine clearance < 15 ml/min)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Primary: composite clinical success at 6 months, defined as the absence of all-cause mortality, unplanned cardiac surgery, embolic events, recurrent bacteremia","definition_or_measurement_approach":"Composite clinical success at 6 months defined as the absence of all-cause mortality, unplanned cardiac surgery, embolic events, and recurrent bacteremia (assessed at 6 months post-treatment)."}
Secondary endpoints
- {"endpoint_text":"- Patient-reported satisfaction at completion of oral treatment.","definition_or_measurement_approach":"Patient-reported satisfaction measured at completion of oral treatment (PRO assessment as recorded at end of oral therapy)."}
- {"endpoint_text":"- Complications (including antibiotic-related adverse events, treatment interruption/modification, non-adherence), during the entire treatment course.","definition_or_measurement_approach":"Complications captured during entire treatment course including antibiotic-related adverse events, treatment interruption/modification and non-adherence (safety and treatment adherence monitoring)."}
- {"endpoint_text":"- PK/PD target attainment of oral antibiotics, assessed per agent, based on predefined PK/PD thresholds at two time point during treatment.","definition_or_measurement_approach":"PK/PD target attainment assessed per antibiotic agent using predefined PK/PD thresholds measured at two time points during treatment (plasma antibiotic concentrations and target level attainment assessment)."}
- {"endpoint_text":"- Length and cost of hospital stay, calculated from admission to discharge.","definition_or_measurement_approach":"Length and cost of hospital stay calculated from admission to discharge (healthcare utilization and cost analysis)."}
- {"endpoint_text":"- Total duration of antibiotic therapy, calculated from treatment initiation until the final antibiotic dose administered for the same endocarditis episode.","definition_or_measurement_approach":"Total duration of antibiotic therapy calculated from treatment initiation until final antibiotic dose administered for the same endocarditis episode."}
Recruitment
- Planned Sample Size
- 152
- Recruitment Window Months
- 60
- Consent Approach
- Voluntary written informed consent required from the participant or their legally authorized representative ("Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures"). Minimum age 18. ICF available for adults in Dutch (document: L1 ICF Adults NL). No assent procedures (minors excluded).
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 152
Belgium
- Earliest CTIS Part Ii Submission Date
- 23-01-2026
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 14
- Number Of Sites
- 1
- Number Of Participants
- 152
Sites
- Site Name
- UZ Leuven
- Department Name
- Internal Medicine
- Contact Person Name
- Liesbet Henckaerts
- Contact Person Email
- Liesbet.henckaerts@uzleuven.be
- Number Of Participants
- 152
Sponsor
Primary sponsor
- Full Name
- UZ Leuven
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- Gentamycine B. Braun 1 mg/ml solution pour perfusion
- Active Substance
- GENTAMICIN
- Modality
- Small molecule
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- Authorised
- Maximum Dose
- 3 mg/kg
- Investigational Product Name
- AmoclaneEG 875 mg/125 mg Filmtabletten
- Active Substance
- AMOXICILLIN TRIHYDRATE, CLAVULANIC ACID
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Authorised
- Maximum Dose
- 2625 mg
- Investigational Product Name
- Amoxicillin AB 1000 mg dispergeerbare tabletten
- Active Substance
- AMOXICILLIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Maximum Dose
- 4000 mg
- Investigational Product Name
- Cefazoline Sandoz 1 g poeder voor oplossing voor injectie
- Active Substance
- CEFAZOLIN SODIUM
- Modality
- Small molecule
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- Authorised
- Maximum Dose
- 6 g
- Investigational Product Name
- Floxapen, poeder voor oplossing voor injectie 1 g
- Active Substance
- FLUCLOXACILLIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 12 g
- Investigational Product Name
- EUSAPRIM Forte 160 mg/800 mg tabletten
- Active Substance
- SULFAMETHOXAZOLE, TRIMETHOPRIM
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Maximum Dose
- 2880 mg
- Investigational Product Name
- Avelox 400 mg Filmtabletten
- Active Substance
- MOXIFLOXACIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Maximum Dose
- 400 mg
- Investigational Product Name
- Delamoxyle 1 g, poudre pour solution injectable/pour perfusion
- Active Substance
- AMOXICILLIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 12 g
- Investigational Product Name
- Ceftriaxone Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusie
- Active Substance
- CEFTRIAXONE SODIUM
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Maximum Dose
- 4 g
- Investigational Product Name
- Clindamycin Sandoz 300 mg harde capsules
- Active Substance
- CLINDAMYCIN HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Maximum Dose
- 1800 mg
- Investigational Product Name
- Rifadine 300 mg capsules, hard
- Active Substance
- RIFAMPICIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Maximum Dose
- 900 mg
- Investigational Product Name
- Penicilline 1.000.000 IE, poeder voor oplossing voor injectie
- Active Substance
- BENZYLPENICILLIN SODIUM
- Modality
- Small molecule
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- Authorised
- Maximum Dose
- 24000000 IU
- Investigational Product Name
- Levofloxacine EG 500 mg comprimés pelliculés
- Active Substance
- LEVOFLOXACIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Maximum Dose
- 1000 mg
- Combination Treatment
- Yes
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