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Are ICU patients getting the right antibiotic dose? new study aims to find out

NCT ID NCT07287813

Knowledge-focused Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether standard antibiotic doses are effective for ICU patients on ECMO (heart-lung support) or kidney dialysis. Researchers will measure drug levels in 40 adults with serious infections. The goal is to see if dosing adjustments are needed to avoid under- or over-treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
beta-lactam antibiotics and beta-lactamase inhibitors
What this could lead to
If successful, this could help doctors give the right antibiotic doses to critically ill patients on life support, improving infection treatment and reducing side effects.
What could go wrong
This is a small, early-stage observational study with only 40 patients. It does not test a new treatment, so results may not change practice immediately.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

ICU patients with ECMO and/or RRT and with gram-negative infections susceptible to BL/BLIs

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * adult patients (age 18y or older) * admitted to ICU * supported or not-supported with extracorporeal membrane oxygenation (ECMO) and/or renal replacement therapy (RRT) * affected by gram-negative bacterial infections susceptible to the novel antibiotics. Exclusion Criteria: * Pediatric age (\<18y) * allergies to pharmaceutical and/or inactive drug ingredients (excipients) * life expectancy less than 1 month * body mass index (BMI) \>45 kg/m2 * pregnancy

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Conditions

The condition(s) this trial relates to.

gram-negative bacterial infections

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Icu patients with ecmo and-or RRT and with gram negative infections susceptible to BL-blis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, Lombardy, 27100, Italy