A Phase 2 interventional study of Meropenem plus vaborbactam in Gram Negative Infections, sponsored by Menarini Group. Recruiting at 22 sites in 5 countries. Open to participants aged 0 Months to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Menarini Group · Phase 2, Interventional, and Treatment
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.
Menarini Group is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single arm study. All participants enrolled will receive the investigational product.
Drug: Meropenem plus vaborbactam
Drug page: Meropenem
Meropenem plus vaborbactam fixed dose combination adjusted by body weight up to 2g/2g
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
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)
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Started Feb 2025 (actual). Primary completion is estimated for Oct 2027, 32 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 7, 2026: primary completion Jul 2026 → Oct 2027 and completion Jul 2026 → Oct 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Meropenem