Gram Negative InfectionsPhase 2NCT06828848
A Study to Assess How Vaborem® is Taking up in the Body and Tolerated in Paediatric Patients With Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections
A Phase 2 study testing Meropenem plus vaborbactam in people with Gram Negative Infections, run by Menarini Group at 22 sites in 5 countries.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 0 months to 17 years
- Conditions the study is for
- Gram Negative Infections
- What is being tested?
- Meropenem plus vaborbactam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 18 Feb 2025to Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 17 years
- All sexes
- No healthy volunteers
- Child
Main Inclusion Criteria:
- Written informed consent before initiation of any study-related procedures.
- Male or female, from birth to < 18 years of age, inclusive.
- Require hospitalization and a minimum of 3 days of IV antibiotic treatment for suspected or confirmed Gram negative infection as per Investigator's judgement.
- Gram negative infection, according to diagnostic criteria for complicated urinary tract infection/acute pyelonephritis (cUTI/AP), complicated intra-Abdominal Infections (cIAI), Hospital-Acquired Pneumonia/Ventilator Associated Pneumonia (HAP/VAP), Blood-Stream Infection (BSI).
Main Exclusion Criteria:
- History of any moderate or significant hypersensitivity or allergic reaction to beta-lactam antibiotics or to any component of the investigational medical product.
- Gram negative infection that in the opinion of the Investigator is unlikely to respond to the study treatment.
- In treatment with immunosuppressive agents, valproic acid, or probenecid.
Trial locations and contacts
22 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 5 countries
Italy6 sites, 5 recruiting
- Recruiting
Policlinico di Bari
Bari
Mario Giordano, Medical Doctor, +39 080 5596804, mario.giordano@policlinico.ba.it
- Recruiting
Ospedale Sant'Orsola
Bologna
Andrea Pasini, Medical Doctor, +39 051 2144613, andrea.pasini@aosp.bo.it
- Terminated
Giannina Gaslini Institute
Genoa
- Recruiting
Azienda Ospedaliero-Universitaria di Parma
Parma
Susanna Maria Roberta Esposito, Medical Doctor, +39 0521702742, susannamariaroberta.esposito@unipr.it
- Recruiting
Ospedale Pediatrico Bambino Gesù
Rome
Alessandra Simonetti, MD, PhD, +39 0668592339, alessandra.simonetti@opbg.net
- Recruiting
Ospedale Regina Margherita
Torino
Silvia Garazzino, MD, PhD, +39 0113135045, silvia.garazzino@unito.it
Spain6 sites, 4 recruiting
- Recruiting
Hospital Sant Joan de Deu
Barcelona
Claudia Fortuny Guasch, Medical Doctor, +34935800148, claudia.fortuny@sjd.es
- Recruiting
Hospital Universitario Puerta del Mar
Cadiz
Ana Castellano Martínez, Medical Doctor, +34 956002774, ana.castellanomart@gmail.com
- Recruiting
Hospital Dr Josep Trueta
Girona
Borja Guarch Ibañez, Medical Doctor, +34 972940200 ext. 2574, bguarch.girona.ics@gencat.cat
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid
David Aguilera-Alonso, Medical Doctor, +34 606663030, david.aguilera@salud.madrid.org
- Terminated
Hospital Regional Universitario de Málaga
Málaga
- Terminated
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela
France5 sites, 3 recruiting
- Recruiting
Hôpital mère-enfant - CHU de Nantes
Nantes
Coline Santy, Medical Doctor, +33 240084953, coline.santy@chu-nantes.fr
- Recruiting
Nice University Hospital (CHU de Nice)
Nice
Diane Demonchy, Medical Doctor, +33 0492030816, diane.demonchy@hpu.lenval.com
- Terminated
Hospital Armand Trousseau Clinical Research Site
Paris
- Recruiting
Hôpital Robert Debré
Paris
Marion Caseris, Medical Doctor, +33171282597, marion.caseris@aphp.fr
- Terminated
CHRU de Tours Hôpital Clocheville Clinical Research Site
Tours
Poland3 sites, 2 recruiting
- Terminated
Insytut Centrum Zdrowia Matki Polki / Polish Mother´s Memorial Hospital Research Institute (ICZMP)
Lodz
- Recruiting
Uniwersyteckie Centrum Kliniczne WUM
Warsaw
Małgorzata Pańczyk-Tomaszewska, PhD, MD, mpanczyk1@wum.edu.pl
- Recruiting
Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
Warsaw
Małgorzata Placzyńska, Medical Doctor, +48 261817216, mplaczynska@wim.mil.pl
Czechia2 sites
- Terminated
Fakultni nemocnice Ostrava
Ostrava
- Terminated
Faculty Hospital Kralovske Vinohrady, Paediatric Clinic
Prague
About this study
Official title: An Open-label, Multicentre, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VaboremⓇ (Meropenem-Vaborbactam) in Paediatric Population With Suspected or Confirmed Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections
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.
- Conditions
- Gram Negative Infections
- Being tested
- Meropenem plus vaborbactam
- Keywords
- pediatric, meropenem, vaborbactam, vaborem, gram negative infection, neonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meropenem plus vaborbactamDrug
Meropenem plus vaborbactam fixed dose combination adjusted by body weight up to 2g/2g
| Study group | Role | What they receive |
|---|---|---|
| Investigational product arm | Experimental | Single arm study. All participants enrolled will receive the investigational product. Receives: Drug: Meropenem plus vaborbactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve (AUC) for Meropenem
Measured: Day 3
Area under the concentration-time curve (AUC) for Vaborbactam
Measured: Day 3
Maximum plasma concentration (Cmax) for Meropenem
Measured: Day 3
Maximum plasma concentration (Cmax) for Vaborbactam
Measured: Day 3
Clearance (CL) of Meropenem
Measured: Day 3
Clearance (CL) of Vaborbactam
Measured: Day 3
Half-life (t1/2) of Meropenem
Measured: Day 3
Half-life (t1/2) of Vaborbactam
Measured: Day 3
Steady-state volume of distribution (Vss) of Meropenem
Measured: Day 3
Steady-state volume of distribution (Vss) of Vaborbactam
Measured: Day 3
Secondary outcomes (1)
Number of patients experiencing Treatment Emergent Adverse Events (TEAE)
Measured: From baseline (day 1) to the last follow up visit (up to day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start18 Feb 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram Negative InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menarini Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828848
- Sponsor's protocol ID
- VABOR-KIDS-01
- Other IDs
- 2024-514656-32-00
- Status last verified
- Sep 2026
- First submitted
- 3 Feb 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicentre, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VaboremⓇ (Meropenem-Vaborbactam) in Paediatric Population With Suspected or Confirmed Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT06828848
- Acronym / sponsor ID
- VABOR-KIDS-01
- Conditions
- Gram Negative Infections
- Keywords
- pediatric, meropenem, vaborbactam, vaborem, gram negative infection, neonate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Menarini GroupIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational product arm | Experimental | Drug: Meropenem plus vaborbactamSingle arm study. All participants enrolled will receive the investigational product. |
Who may qualify
- Ages
- 0 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meropenem plus vaborbactamMeropenem plus vaborbactam fixed dose combination adjusted by body weight up to 2g/2g | Drug | Investigational product arm |
Primary outcome
Area under the concentration-time curve (AUC) for Meropenem
Time frame: Day 3
Area under the concentration-time curve (AUC) for Vaborbactam
Time frame: Day 3
Maximum plasma concentration (Cmax) for Meropenem
Time frame: Day 3
Maximum plasma concentration (Cmax) for Vaborbactam
Time frame: Day 3
Clearance (CL) of Meropenem
Time frame: Day 3
Clearance (CL) of Vaborbactam
Time frame: Day 3
Half-life (t1/2) of Meropenem
Time frame: Day 3
Half-life (t1/2) of Vaborbactam
Time frame: Day 3
Steady-state volume of distribution (Vss) of Meropenem
Time frame: Day 3
Steady-state volume of distribution (Vss) of Vaborbactam
Time frame: Day 3
1 secondary outcome
Number of patients experiencing Treatment Emergent Adverse Events (TEAE)
Time frame: From baseline (day 1) to the last follow up visit (up to day 30)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Meropenem plus vaborbactam in people with Gram Negative Infections, run by Menarini Group at 22 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Italy, Spain, France, Poland, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Bertolotti, Medical Doctor (+39 055 56809922, vabor-kids@menarini-ricerche.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve (AUC) for Meropenem (time frame: Day 3). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.