Efficacy and safety of Dalbavancin in the treatment of infective Endocarditis caused by gram-positive cocci

Status Authorised, recruitment pending · 1 EU/EEA countries · 9 sites · Protocol ZKSJ0165

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Authorised, recruitment pending

Participants planned 166

Countries 1

Sites 9

Infectious endocarditis caused by Gram-positive cocci (staphylococci, enterococci, streptococci)

The objective of the study is to determine whether treatment with dalbavancin improves treatment success at day 90 in patients with endocarditis caused by Grampositive cocci, compared with the recommended standard antibiotic therapy (including sequential intravenous-oral therapy).

Key facts

Sponsor: Friedrich-Schiller-Universitaet Jena
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Bacterial Infections and Mycoses [C01]
Decision date (initial): 2026-06-30
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

Secondary objectives 3

To investigate the impact of the intervention on: • health economic parameters • neurological outcome • the microbiome and the development of resistance • Quality of life and mental health
Safety of the intervention
Pharmacokinetics/pharmacodynamics

Conditions and MedDRA coding

Infectious endocarditis caused by Gram-positive cocci (staphylococci, enterococci, streptococci)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

≥ 18 years
written informed consent
Confirmed infective left-sided endocarditis (mitral and/or aortic valve) involving native (NV) or prosthetic (PV) valves caused by Gram-positive cocci (staphylococci, streptococci, or enterococci) that are susceptible to dalbavancin.

Exclusion criteria 18

Hemodynamic instability requiring vasopressor therapy within the last 72 hours prior to randomization
Body temperature ≥38.0°C within the 72 hours prior to randomization
Evidence of pathogen growth in a blood culture within the 72 hours prior to randomization
Presence of a cardiac abscess at the time of randomization
Presence of a remaining infected cardiovascular implantable electronic device (CIED), an infected intravascular graft, or an infected TAVI prosthesis (“TAVI endocarditis”) at the time of randomization
Duration of effective intravenous antibiotic therapy for endocarditis of < 7 days prior to randomization
Remaining duration of required antibiotic therapy for the treatment of endocarditis is less than 10 days (i.e., remaining treatment duration must be at least 10 days)
Hypersensitivity to dalbavancin, vancomycin, teicoplanin, or other components of the investigational drug
Participation in another clinical interventional trial under the German Medicines Act (AMG), Medical Devices Regulation (MDR), or Medical Devices Act (MPDG) without prior consultation and approval by the respective sponsors prior to randomization
Continuous renal replacement therapy (e.g., CVVHD, CVVHDF)
Child B or C liver cirrhosis
Palliative care
Secondary infections requiring a longer course of antibiotic therapy than that intended for the treatment of endocarditis
Oral antibiotic therapy already initiated to treat the current episode of endocarditis
Scheduled cardiac surgery after randomization, within the period designated for antibiotic treatment of endocarditis
Intraspinal or brain abscess (> 0.5 cm)
Pregnant and breastfeeding women
Women of childbearing potential, unless the following criteria are met: a. Postmenopausal (12 months of natural amenorrhea or 6 months of amenorrhea with serum FSH > 40 mIU/mL) b. Postoperative (6 weeks after bilateral oophorectomy with or without hysterectomy) c. Regular and correct use of a contraceptive method with a failure rate < 1% per year (considered reliable contraceptive methods include oral hormonal contraception, dermal hormonal contraception, contraceptive patches, long-acting injectable contraceptives, progesterone-releasing implants (Implanon®), intramuscular progesterone, tubal ligation (female sterilization), hormone-releasing intrauterine device (“hormonal IUD”), dual barrier methods) d. sexual abstinence e. Vasectomy of the partner

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Comparison of the Desirability of Outcome Ranking (DOOR) on Day 90 between patients treated with dalbavancin and those treated with standard therapy. Five possible DOOR ratings are distinguished: • Alive, no events • Alive, one event • Alive, two events • Alive, three events • Death within 90 days. Door events include: Cardiac surgery, Infectious complication, Embolic event

Secondary endpoints 11

Health economic parameters at T90 (including length of hospital stay in days; costs of antibiotic therapy; number of days of work disability)
Neurological outcome (National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS) at Day 90 and 1 year
Health-related quality of life (PROMIS-29 domain-specific T-scores and pain intensity, EQ-5D-5L index and VAS, RNLI total score) at 90 days and 1 year
Overall mortality at 90 days and 1 year
Cardiac surgery at 90 days and 1 year
Infectious complications at 90 days and 1 year
Embolic event at 90 days and 1 year
Clinical Frailty Scale at 90 days and 1 year
Occurrence of treatment-related adverse events (T0 to EOT+14 days)
Dalbavancin level determination and pharmacokinetic analysis (only patients in the intervention group) T1, T2, T14, and if applicable, T21/28/35
Microbiome analysis and resistance development (nasopharyngeal and rectal swabs/stool samples) T0, T90, and 1 year

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Dalbavancin

SUB26697 · Substance

Active substance: Dalbavancin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 1500 mg milligram(s)
Max total dose: 2500 mg milligram(s)
Max treatment duration: 2 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Comparator 39

Amoxicillin

SUB05481MIG · Substance

Active substance: Amoxicillin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 6 g gram(s)
Max total dose: 210 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Amoxicillin

SUB05481MIG · Substance

Active substance: Amoxicillin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 2.5 g gram(s)
Max total dose: 91.8 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Clavulanic Acid

SUB06642MIG · Substance

Active substance: Clavulanic Acid
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 375 mg milligram(s)
Max total dose: 13.12 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ampicillin

SUB05487MIG · Substance

Active substance: Ampicillin
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS USE
Max daily dose: 15 g gram(s)
Max total dose: 525 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ampicillin

SUB05487MIG · Substance

Active substance: Ampicillin
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS USE
Max daily dose: 8 g gram(s)
Max total dose: 280 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cefazolin

SUB07379MIG · Substance

Active substance: Cefazolin
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 12 g gram(s)
Max total dose: 420 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cefotaxime

SUB07405MIG · Substance

Active substance: Cefotaxime
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 12 g gram(s)
Max total dose: 420 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ceftriaxone

SUB07431MIG · Substance

Active substance: Ceftriaxone
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 4 g gram(s)
Max total dose: 140 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Daptomycin

SUB06910MIG · Substance

Active substance: Daptomycin
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 6 mg/kg milligram(s)/kilogram
Max total dose: 210 mg/kg milligram(s)/kilogram
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sulbactam

SUB10676MIG · Substance

Active substance: Sulbactam
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 4 g gram(s)
Max total dose: 140 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Flucloxacillin

SUB07673MIG · Substance

Active substance: Flucloxacillin
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 12 g gram(s)
Max total dose: 420 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Fosfomycin

SUB07797MIG · Substance

Active substance: Fosfomycin
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS USE
Max daily dose: 24 g gram(s)
Max total dose: 840 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cefalexin

SUB06165MIG · Substance

Active substance: Cefalexin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 4 g gram(s)
Max total dose: 140 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cefaclor

SUB06163MIG · Substance

Active substance: Cefaclor
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL USE
Max daily dose: 4 g gram(s)
Max total dose: 140 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Gentamicin Sulfate

SUB02327MIG · Substance

Active substance: Gentamicin Sulfate
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 6 mg/kg milligram(s)/kilogram
Max total dose: 210 mg/kg milligram(s)/kilogram
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Imipenem

SUB08151MIG · Substance

Active substance: Imipenem
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 4 g gram(s)
Max total dose: 140 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Cilastatin

SUB06264MIG · Substance

Active substance: Cilastatin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 4 g gram(s)
Max total dose: 140 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Linezolid

SUB08520MIG · Substance

Active substance: Linezolid
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 1.2 g gram(s)
Max total dose: 33.6 g gram(s)
Max treatment duration: 28 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Linezolid

SUB08520MIG · Substance

Active substance: Linezolid
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 1.2 g gram(s)
Max total dose: 33.6 g gram(s)
Max treatment duration: 28 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Meropenem

SUB08778MIG · Substance

Active substance: Meropenem
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 6 g gram(s)
Max total dose: 210 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Moxifloxacin

SUB09086MIG · Substance

Active substance: Moxifloxacin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 0.4 g gram(s)
Max total dose: 14 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Moxifloxacin

SUB09086MIG · Substance

Active substance: Moxifloxacin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 0.4 g gram(s)
Max total dose: 14 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Phenoxymethylpenicillin

SUB09779MIG · Substance

Active substance: Phenoxymethylpenicillin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 6000000 IU international unit(s)
Max total dose: 210000000 IU international unit(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Benzylpenicillin Potassium

SUB13036MIG · Substance

Active substance: Benzylpenicillin Potassium
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS USE
Max daily dose: 60000000 IU international unit(s)
Max total dose: 2100000000 IU international unit(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rifampicin

SUB10309MIG · Substance

Active substance: Rifampicin
Pharmaceutical form: POWDER FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 1.2 g gram(s)
Max total dose: 21 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Rifampicin

SUB10309MIG · Substance

Active substance: Rifampicin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 1.2 g gram(s)
Max total dose: 21 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Teicoplanin

SUB04714MIG · Substance

Active substance: Teicoplanin
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION/INFUSION OR ORAL SOLUTION
Route of administration: INTRAVENOUS USE
Max daily dose: 24 mg/kg milligram(s)/kilogram
Max total dose: 840 mg/kg milligram(s)/kilogram
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sulfamethoxazole

SUB10711MIG · Substance

Active substance: Sulfamethoxazole
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 8 g gram(s)
Max total dose: 280 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Trimethoprim

SUB11310MIG · Substance

Active substance: Trimethoprim
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 1.6 g gram(s)
Max total dose: 56 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Vancomycin

SUB05076MIG · Substance

Active substance: Vancomycin
Pharmaceutical form: POWDER FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 60 mg/kg milligram(s)/kilogram
Max total dose: 2100 mg/kg milligram(s)/kilogram
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ciprofloxacin

SUB07470MIG · Substance

Active substance: Ciprofloxacin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 1.5 g gram(s)
Max total dose: 52.5 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ciprofloxacin

SUB07470MIG · Substance

Active substance: Ciprofloxacin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 1.2 g gram(s)
Max total dose: 42 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Doxycycline

SUB06393MIG · Substance

Active substance: Doxycycline
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 0.3 g gram(s)
Max total dose: 10.5 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Doxycycline

SUB06393MIG · Substance

Active substance: Doxycycline
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS USE
Max daily dose: 0.3 g gram(s)
Max total dose: 10.5 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Levofloxacin

SUB08471MIG · Substance

Active substance: Levofloxacin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 1 g gram(s)
Max total dose: 35 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Levofloxacin

SUB08471MIG · Substance

Active substance: Levofloxacin
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 1 g gram(s)
Max total dose: 35 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Ceftaroline Fosamil

SUB31648 · Substance

Active substance: Ceftaroline Fosamil
Pharmaceutical form: POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 1.8 g gram(s)
Max total dose: 63 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sulfamethoxazole

SUB10711MIG · Substance

Active substance: Sulfamethoxazole
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 2 g gram(s)
Max total dose: 70 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Trimethoprim

SUB11310MIG · Substance

Active substance: Trimethoprim
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 0.4 g gram(s)
Max total dose: 14 g gram(s)
Max treatment duration: 5 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Friedrich-Schiller-Universitaet Jena

Sponsor organisation: Friedrich-Schiller-Universitaet Jena
Address: Am Klinikum 1, Lobeda Lobeda
City: Jena
Postcode: 07747
Country: Germany

Scientific contact point

Organisation: Friedrich-Schiller-Universitaet Jena
Contact name: PD Dr. Stefan Hagel

Public contact point

Organisation: Friedrich-Schiller-Universitaet Jena
Contact name: PD Dr. Stefan Hagel

Third parties 2

Organisation	City, country	Duties
Universitaetsklinikum Jena KöR ORG-100022519	Jena, Germany	Laboratory analysis
Universitaetsklinikum Heidelberg AöR ORG-100013733	Heidelberg, Germany	Laboratory analysis

Locations

1 EU/EEA country · 9 investigational sites

By country

Country	MS status	Planned subjects	Sites
Germany	Authorised, recruitment pending	166	9
Rest of world	—	0	—

Investigational sites

Germany

9 sites · Authorised, recruitment pending

Charite Universitaetsmedizin Berlin KöR

Klinik für Infektiologie und Intensivmedizin, Augustenburger Platz 1, Wedding, Berlin

Vivantes Netzwerk fuer Gesundheit GmbH

Zentrum für Infektionsmedizin, Rubensstrasse 125/2, Schoeneberg, Berlin

Universitaetsklinikum Jena KöR

Institut für Infektionsmedizin und Krankenhaushygiene, Am Klinikum 1, Lobeda, Jena

Medical Center - University Of Freiburg

Klinik für Innere Medizin II, Abteilung Infektiologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau

Universitaetsklinikum Regensburg AöR

Infektiologie, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg

HELIOS Klinikum Erfurt GmbH

Allgemeine und Inverventionelle Kardiologie, Nordhaeuser Strasse 74, Andreasvorstadt, Erfurt

University Medical Center Hamburg-Eppendorf

Institut für Infektionsforschung und Impfstoffentwicklung, Sektion Infektiologie, Martinistrasse 52, Eppendorf, Hamburg

Universitaetsklinikum Koeln AöR

Klinik I für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne

Klinikum St. Georg gGmbH

Klinik für Infektiologie und Tropenmedizin, Delitzscher Strasse 141, Eutritzsch, Leipzig

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 43 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol 2026-526149-91-00_p	02
Protocol (for publication)	D1_questionair_EQ-ED-5L	1
Protocol (for publication)	D1_questionair_PROMIS	1
Protocol (for publication)	D1_questionair_RNLI	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1
Subject information and informed consent form (for publication)	L1_ICF Patient	2
Subject information and informed consent form (for publication)	L1_ICF Patient_p	2
Subject information and informed consent form (for publication)	L1_ICF Patient_TC	2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_ Penicillin-V	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_ Trimethoprim-Sulfamethoxazol	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_ Trimethoprim-Sulfamethoxazol_2	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Amoxicillin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Amoxicillin-Clavulansaure	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Ampicillin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Ampicillin-Sulbactam	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Cefaclor	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Cefalexin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Cefazolin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Cefotaxim	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Ceftarolin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Ceftriaxon	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Ciprofloxacin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Ciprofloxacin_2	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Dalbavancin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Daptomycin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Doxycyclin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Doxycyclin_2	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Flucloxacillin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Fosfomycin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Gentamicin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Imipenem	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Levofloxacin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Levofloxacin_2	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Linezolid	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Linezolid_2	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Meropenem	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Moxifloxacin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Moxifloxacin_2	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Penicillin-G	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Rifampicin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Rifampicin_2	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Teicoplanin	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC_Vancomycin	1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2026-04-29	Germany	Acceptable 2026-06-26	2026-06-30