Overview
Sponsor-declared trial summary
brain tumors
To measure concentrations of different antibiotics in CSF and plasma after intravenous or oral administration of different antibiotics in children with a malignant brain tumor and leptomeningeal dissemination or risk of leptomeningeal dissemination.
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 22 Oct 2018 → ongoing
- Decision date (initial)
- 2024-12-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518808-43-00
- EudraCT number
- 2018-002813-37
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic
To measure concentrations of different antibiotics in CSF and plasma after intravenous or oral administration of different antibiotics in children with a malignant brain tumor and leptomeningeal dissemination or risk of leptomeningeal dissemination.
Secondary objectives 2
- -Pharmacokinetik/Pharmacodynamic relationships
- -Determination of target attainment for relevant pathogens
Conditions and MedDRA coding
brain tumors
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Written informed consent of patients and/or parents
- Female or male, aged between 0 and 18 years (at time of initial diagnosis)
- CNS tumor with leptomeningeal dissemination or risk of leptomeningeal dissemination of any histology
- Ongoing treatment with intravenous or oral antibiotics for therapeutic reasons
- Ongoing treatment with intrathecal administered chemotherapy via an Ommaya reservoir for therapeutic reasons
- Life expectancy of at least 8 weeks
Exclusion criteria 3
- Treatment with intravenous or oral antibiotics or intrathecal therapy not indicated
- Contraindication for the puncture of the Ommaya reservoir or for administration of intrathecal chemotherapy (e.g. evidence of obstructive hydrocephalus or compartmentalization of CSF flow)
- Pregnancy or breast feeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- Area under the concentration-time curve (AUC) from 0 to last observed concentration (AUC0-τ)
- AUC from 0 to 24 hours (AUC0-24)
- concentration during therapy and at defined time points after end of therapy
- Pharmacokinetic parameters describing rate/extent of distribution from plasma into CSF
Secondary endpoints 4
- ratio of the CSF AUC0-24 to the minimum inhibitory concentration (AUC0-24/MIC)
- percentage of the dosing interval during which drug concentrations in CSF exceed the MIC (%T>MIC)
- ratio of the peak CSF concentration to the MIC (Cmax/MIC)
- Determination of target attainment for relevant pathogens
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 12
Linezolid Kabi 2 mg/ml Infusionslösung
PRD2479886 · Product
- Active substance
- Linezolid
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- J01XX08 — LINEZOLID
- Marketing authorisation
- 135944
- MA holder
- FRESENIUS KABI AUSTRIA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Gentamicin Sandoz 80 mg – Ampullen
PRD766741 · Product
- Active substance
- Gentamicin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- J01GB03 — GENTAMICIN
- Marketing authorisation
- 1-18856
- MA holder
- SANDOZ GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cefotaxim-MIP 1 g – Pulver zur Herstellung einer Injektions- oder Infusionslösung
PRD625459 · Product
- Active substance
- Cefotaxime Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- J01DD01 — -
- Marketing authorisation
- 1-31395
- MA holder
- MIP PHARMA AUSTRIA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Augmentin 875 mg/125 mg Filmtabletten
PRD11466180 · Product
- Active substance
- Amoxicillin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- J01CR02 — AMOXICILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- 1-21396
- MA holder
- GLAXOSMITHKLINE PHARMA GMBH.
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fomicyt 40 mg/ml Pulver zur Herstellung einer Infusionslösung
PRD7777251 · Product
- Active substance
- Fosfomycin
- Substance synonyms
- (3-METHYLOXIRAN-2-YL)PHOSPHONIC ACID, PHOSPHOMYCIN, PHOSPHONOMYCIN
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- J01XX01 — FOSFOMYCIN
- Marketing authorisation
- 139243
- MA holder
- INFECTOPHARM ARZNEIMITTEL UND CONSILIUM GMBH, DE, HEPPENHEIM
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cefuroxim „Astro“ - Trockenstechampulle
PRD4922276 · Product
- Active substance
- Cefuroxime Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- J01DC02 — -
- Marketing authorisation
- 1-22175
- MA holder
- ASTRO-PHARMA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Vancomycin Hikma 1000 mg - Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
PRD1183401 · Product
- Active substance
- Vancomycin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- 1-31670
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ceftriaxon Kabi 1 g Pulver zur Herstellung einer Injektions- /Infusionslösung
PRD408948 · Product
- Active substance
- Ceftriaxone Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- J01DD04 — -
- Marketing authorisation
- 1-27378
- MA holder
- FRESENIUS KABI AUSTRIA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Meropenem Hikma 1g Pulver zur Herstellung einer Injektions-/Infusionslösung
PRD719711 · Product
- Active substance
- Meropenem Anhydrous
- Substance synonyms
- ICI-194660
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- J01DH02 — MEROPENEM
- Marketing authorisation
- 1-29759
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ciprofloxacin Noridem 2 mg/ml Infusionslösung
PRD384744 · Product
- Active substance
- Ciprofloxacin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- J01MA02 — CIPROFLOXACIN
- Marketing authorisation
- 1 30042
- MA holder
- NORIDEM ENTERPRISES LTD
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD980537 · Product
- Active substance
- Sulfamethoxazole
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- J01EE01 — SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Marketing authorisation
- 14.247
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD385404 · Product
- Active substance
- Ciprofloxacin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- J01MA02 — CIPROFLOXACIN
- Marketing authorisation
- 1-18296
- MA holder
- BAYER AUSTRIA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Vienna
- Sponsor organisation
- Medical University Of Vienna
- Address
- Spitalgasse 23, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Clinical Pharmacology
Public contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Department of Clinical Pharmacology
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 60 | 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 |
|---|---|---|---|---|---|
| Austria | 2018-10-22 | 2018-11-16 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-05 | Austria | Acceptable 2024-12-06
|
2024-12-11 |