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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514656-32-00 | EU Trial (CTIS) Number |
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The goal of this clinical trial is to assess the pharmacokinetic (PK) and safety and tolerability of Vaborem (fixed combination of meropenem and vaborbactam) in the paediatric population aged from birth to < 18 years with suspected or confirmed Gram negative infections in need of hospitalisation and intravenous (IV) antibiotic administration.
All participants will receive Vaborem IV every 8 hours to treat the suspected or confirmed Gram negative infections for 10 up to 14 days; switch to stepdown oral antibiotic is allowed after a minimum of 3 days of Vaborem. PK sample collection will occur after at least 6 doses administration.
Participant's clinical conditions will be monitored during the entire duration of the hospitalization and during scheduled visit/s after the completion of the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational product arm | Experimental | Single arm study. All participants enrolled will receive the investigational product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meropenem plus vaborbactam | Drug | Meropenem plus vaborbactam fixed dose combination adjusted by body weight up to 2g/2g |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC) for Meropenem | Day 3 | |
| Area under the concentration-time curve (AUC) for Vaborbactam | Day 3 | |
| Maximum plasma concentration (Cmax) for Meropenem | Day 3 | |
| Maximum plasma concentration (Cmax) for Vaborbactam | Day 3 | |
| Clearance (CL) of Meropenem | Day 3 | |
| Clearance (CL) of Vaborbactam | Day 3 | |
| Half-life (t1/2) of Meropenem | Day 3 | |
| Half-life (t1/2) of Vaborbactam | Day 3 | |
| Steady-state volume of distribution (Vss) of Meropenem | Day 3 | |
| Steady-state volume of distribution (Vss) of Vaborbactam | Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients experiencing Treatment Emergent Adverse Events (TEAE) | From baseline (day 1) to the last follow up visit (up to day 30) |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monica Bertolotti, Medical Doctor | Contact | +39 055 56809922 | vabor-kids@menarini-ricerche.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fakultni nemocnice Ostrava | Recruiting | Ostrava | Czechia |
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| Faculty Hospital Kralovske Vinohrady, Paediatric Clinic | Recruiting | Prague | Czechia |
|
| Hôpital mère-enfant - CHU de Nantes | Recruiting | Nantes | France |
|
| Nice University Hospital (CHU de Nice) | Recruiting | Nice | France |
|
| Hospital Armand Trousseau Clinical Research Site | Recruiting | Paris | France |
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| Hôpital Robert Debré | Recruiting | Paris | France |
|
| CHRU de Tours Hôpital Clocheville Clinical Research Site | Recruiting | Tours | France |
|
| Policlinico di Bari | Recruiting | Bari | Italy |
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| Ospedale Sant'Orsola | Recruiting | Bologna | Italy |
|
| Giannina Gaslini Institute | Recruiting | Genoa | Italy |
|
| Azienda Ospedaliero-Universitaria di Parma | Recruiting | Parma | Italy |
|
| Ospedale Pediatrico Bambino Gesù | Recruiting | Rome | Italy |
|
| Ospedale Regina Margherita | Recruiting | Torino | Italy |
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| Insytut Centrum Zdrowia Matki Polki / Polish Mother´s Memorial Hospital Research Institute (ICZMP) | Withdrawn | Lodz | Poland |
| Uniwersyteckie Centrum Kliniczne WUM | Recruiting | Warsaw | Poland |
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| Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy | Recruiting | Warsaw | Poland |
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| Hospital Sant Joan de Deu | Recruiting | Barcelona | Spain |
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| Hospital Universitario Puerta del Mar | Recruiting | Cadiz | Spain |
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| Hospital Dr Josep Trueta | Recruiting | Girona | Spain |
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| Hospital General Universitario Gregorio Marañón | Recruiting | Madrid | Spain |
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| Hospital Regional Universitario de Málaga | Recruiting | Málaga | Spain |
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| Hospital Clinico Universitario de Santiago de Compostela | Recruiting | Santiago de Compostela | Spain |
|
| ID | Term |
|---|---|
| D000077731 | Meropenem |
| C000626994 | vaborbactam |
| ID | Term |
|---|---|
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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