Overview
Sponsor-declared trial summary
patients with external ventricular drain
To determine the pharmacokinetics of cefuroxime, vancomycin, gentamicin, ampicillin, linezolid, piperacillin/tazobactam and cefazolin in CSF of children with external ventricular drain.
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 30 Aug 2018 → 8 Jan 2026
- Decision date (initial)
- 2024-09-08
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515791-12-00
- EudraCT number
- 2018-002278-33
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic
To determine the pharmacokinetics of cefuroxime,
vancomycin, gentamicin, ampicillin, linezolid,
piperacillin/tazobactam and cefazolin in CSF of children with
external ventricular drain.
Secondary objectives 2
- Calculation of pharmacokinetic/pharmacodynamic (PK/PD) parameters considering currently established/discussed breakpoints
- Determination of target attainment analysis for different pathogens
Conditions and MedDRA coding
patients with external ventricular drain
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Female or male, aged between 3 days and 3 months (study groups C, V, A, P and CZ)
- Female or male, aged between 7 days and 3 months (study group G and L)
- External ventricular drain in place
- Hospitalisation on an intensive care or intermediate care unit
- Clinical diagnosis of infection, requiring antibiotic therapy or antibiotic therapy as infection prophylaxis
- Current or planned therapy with cefuroxime, gentamicin, vancomycin, ampicillin, linezolid , piperacillin/tazobactam or cefazolin as treatment or prophylaxis of a bacterial infection (any localisation).
- Signed informed consent by at least one parent or legal representative
Exclusion criteria 3
- Allergy or hypersensitivity against study drug.
- Severe renal impairment, defined by a serum creatinine level of more than 200% of age-specific reference values, or urinary output <0,5ml/kg/h for >12 hours
- Any disease considered a risk for proper performance of the study or risks to the patient, at the discretion of the investigator
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- Maximum concentration (Cmax) in CSF
- time to maximum concentration (tmax) in CSF
- area under the concentration time curve from zero to last observed concentration (AUC0-τ) in CSF
- half-life (t1/2) in CSF
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 7
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 500 mg - Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
PRD1183399 · Product
- Active substance
- Vancomycin
- Substance synonyms
- VANCOMYCINUM
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- 1-31669
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Gentamicin Sandoz 80 mg – Ampullen
PRD766741 · Product
- Active substance
- Gentamicin
- Substance synonyms
- 2-[4,6-DIAMINO-3-[3-AMINO-6-(1-METHYLAMINOETHYL)OXAN-2-YL]OXY-2-HYDROXY-CYCLOHEXYL]OXY-5-METHYL-4-METHYLAMINO-OXANE-3,5-DIOL, 2-[4,6-DIAMINO-3-[3-AMINO-6-(1-METHYLAMINOETHYL)OXAN-2-YL]OXY-2-HYDROXYCYCLOHEXYL]OXY-5-METHYL-4-METHYLAMINOOXANE-3,5-DIOL
- 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
Kefzol 1 g – Trockenstechampullen
PRD4852199 · Product
- Active substance
- Cefazolin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- J01DB04 — -
- Marketing authorisation
- 15.629
- MA holder
- ASTRO-PHARMA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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
Standacillin 1 g – Pulver zur Herstellung einer Injektions-/Infusionslösung
PRD910693 · Product
- Active substance
- Ampicillin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- J01CA01 — AMPICILLIN
- Marketing authorisation
- 17200
- MA holder
- SANDOZ GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Piperacillin/Tazobactam Kabi 4 g/0,5 g Pulver zur Herstellung einer Infusionslösung
PRD767217 · Product
- Active substance
- Piperacillin Sodium
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Authorisation status
- Authorised
- ATC code
- J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- 1-27840
- MA holder
- FRESENIUS KABI 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 | Ended | 56 | 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 | 2018-08-30 | 2018-10-04 | 2026-01-08 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-21 | Austria | Acceptable 2024-09-04
|
2024-09-08 |