Clinical trial • Phase I • Oncology|Infectious Disease

Amoxicillin, Clavulanic acid for Malignant brain tumor|Leptomeningeal dissemination

Phase I trial of Amoxicillin, Clavulanic acid for Malignant brain tumor|Leptomeningeal dissemination. 60 participants.

Overview

Trial Therapeutic Area: Oncology|Infectious Disease
Trial Disease: Malignant brain tumor|Leptomeningeal dissemination
Trial Stage: Phase I
Drug Modality: Small molecule
Paediatric Trial: Yes

Key dates

Initial CTIS Submission Date: 05-11-2024
First CTIS Authorization Date: 11-12-2024

Trial design

Phase I trial across 1 site in Austria.

Target Sample Size: 60

Eligibility

Recruits 60 paediatric patients.

Pregnancy Exclusion: Pregnancy or breast feeding
Vulnerable Population: Participants are children aged between 0 and 18 years. Consent statement: "Written informed consent of patients and/or parents" — consent may be provided by patients and/or parents; no further details on assent or separate age-specific consent documents are provided.

Inclusion criteria

{"criterion_text":"-Written informed consent of patients and/or parents"}
{"criterion_text":"-Female or male, aged between 0 and 18 years (at time of initial diagnosis)"}
{"criterion_text":"-CNS tumor with leptomeningeal dissemination or risk of leptomeningeal dissemination of any histology"}
{"criterion_text":"-Ongoing treatment with intravenous or oral antibiotics for therapeutic reasons"}
{"criterion_text":"-Ongoing treatment with intrathecal administered chemotherapy via an Ommaya reservoir for therapeutic reasons"}
{"criterion_text":"-Life expectancy of at least 8 weeks"}

Exclusion criteria

{"criterion_text":"-Treatment with intravenous or oral antibiotics or intrathecal therapy not indicated"}
{"criterion_text":"-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)"}
{"criterion_text":"-Pregnancy or breast feeding"}

Endpoints

Primary endpoints

{"endpoint_text":"-Area under the concentration-time curve (AUC) from 0 to last observed concentration (AUC0-τ)","definition_or_measurement_approach":"AUC calculated from measured antibiotic concentration-time data in plasma and CSF (concentration measurements over time)."}
{"endpoint_text":"-AUC from 0 to 24 hours (AUC0-24)","definition_or_measurement_approach":"AUC0-24 calculated from concentration-time measurements in plasma and CSF over 24 hours."}
{"endpoint_text":"-concentration during therapy and at defined time points after end of therapy","definition_or_measurement_approach":"Serial measurement of antibiotic concentrations in CSF and plasma during therapy and at predefined post-therapy time points."}
{"endpoint_text":"-Pharmacokinetic parameters describing rate/extent of distribution from plasma into CSF","definition_or_measurement_approach":"Pharmacokinetic analysis comparing plasma and CSF concentration data to derive distribution parameters (e.g., penetration ratios, rate constants)."}

Secondary endpoints

{"endpoint_text":"-ratio of the CSF AUC0-24 to the minimum inhibitory concentration (AUC0-24/MIC)","definition_or_measurement_approach":"Calculation of CSF AUC0-24 divided by pathogen MIC values to assess pharmacodynamic target attainment."}
{"endpoint_text":"-percentage of the dosing interval during which drug concentrations in CSF exceed the MIC (%T>MIC)","definition_or_measurement_approach":"Determination of proportion of dosing interval with CSF concentrations > MIC based on concentration-time profiles and known MICs."}
{"endpoint_text":"-ratio of the peak CSF concentration to the MIC (Cmax/MIC)","definition_or_measurement_approach":"Calculation of CSF peak concentration divided by pathogen MIC to evaluate peak-related pharmacodynamic effect."}
{"endpoint_text":"-Determination of target attainment for relevant pathogens","definition_or_measurement_approach":"Assessment of pharmacokinetic/pharmacodynamic indices (e.g., AUC/MIC, %T>MIC, Cmax/MIC) against targets for pathogens of interest."}

Recruitment

Planned Sample Size: 60
Recruitment Window Months: 120
Consent Approach: Written informed consent of patients and/or parents. No additional detail provided on assent, age-specific consent forms, or languages.

Geography

Total Number Of Sites: 1
Total Number Of Participants: 60

Austria

Earliest CTIS Part Ii Submission Date: 18-11-2024
Latest Decision Or Authorization Date: 11-12-2024
Processing Time Days: 23
Number Of Sites: 1
Number Of Participants: 60

Sites

Site Name: Medical University Of Vienna
Department Name: Department of Clinical Pharmacology
Principal Investigator Name: Andreas Peyrl
Principal Investigator Email: andreas.peyrl@meduniwien.ac.at
Contact Person Name: Andreas Peyrl
Contact Person Email: andreas.peyrl@meduniwien.ac.at

Sponsor

Primary sponsor

Full Name: Medical University Of Vienna
Organisation Type: Educational Institution
Country Of Registered Address: Austria

Investigational products

Investigational Product Name: Augmentin 875 mg/125 mg Filmtabletten
Active Substance: Amoxicillin, Clavulanic acid
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised

Investigational Product Name: Ciprofloxacin Noridem 2 mg/ml Infusionslösung
Active Substance: Ciprofloxacin
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: INTRAVENOUS INFUSION
Authorisation Status: Authorised

Investigational Product Name: Eusaprim - Tabletten
Active Substance: Sulfamethoxazole, Trimethoprim
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised

Investigational Product Name: Cefotaxim-MIP 1 g – Pulver zur Herstellung einer Injektions- oder Infusionslösung
Active Substance: Cefotaxime sodium
Modality: Small molecule
Routes Of Administration: INTRAVENIOUS INFUSION
Route: INTRAVENIOUS INFUSION
Authorisation Status: Authorised

Investigational Product Name: Fomicyt 40 mg/ml Pulver zur Herstellung einer Infusionslösung
Active Substance: Fosfomycin
Modality: Small molecule
Routes Of Administration: INTRAVENIOUS INFUSION
Route: INTRAVENIOUS INFUSION
Authorisation Status: Authorised

Investigational Product Name: Cefuroxim „Astro" - Trockenstechampulle
Active Substance: Cefuroxime sodium
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: INTRAVENOUS INFUSION
Authorisation Status: Authorised

Investigational Product Name: Ciproxin 500 mg Filmtabletten
Active Substance: Ciprofloxacin
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised

Investigational Product Name: Ceftriaxon Kabi 1 g Pulver zur Herstellung einer Injektions- /Infusionslösung
Active Substance: Ceftriaxone sodium
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: INTRAVENOUS INFUSION
Authorisation Status: Authorised

Investigational Product Name: Linezolid Kabi 2 mg/ml Infusionslösung
Active Substance: Linezolid
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: INTRAVENOUS INFUSION
Authorisation Status: Authorised

Investigational Product Name: Vancomycin Hikma 1000 mg - Pulver für ein Konzentrat zur Herstellung einer Infusionslösung
Active Substance: Vancomycin
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: INTRAVENOUS INFUSION
Authorisation Status: Authorised

Investigational Product Name: Meropenem Hikma 1g Pulver zur Herstellung einer Injektions-/Infusionslösung
Active Substance: Meropenem anhydrous
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: INTRAVENOUS INFUSION
Authorisation Status: Authorised

Investigational Product Name: Gentamicin Sandoz 80 mg – Ampullen
Active Substance: Gentamicin
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INFUSION
Route: INTRAVENOUS INFUSION
Authorisation Status: Authorised

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