Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Nebulized Amikacin for Treating Ventilator-Associated Gram-Negative Pneumonia in Patients on Veno-Arterial ECMO

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a lung infection known as ventilator-associated pneumonia, which occurs in patients who are on a breathing machine and receiving a type of life support called Extracorporeal Membrane Oxygenation (ECMO). The study is investigating the use of a medication called amikacin sulfate, which is given as a mist to be inhaled into the lungs, in addition to the usual antibiotic treatment. The usual treatment includes a combination of two substances, piperacillin sodium and tazobactam sodium, which are given through a vein.

The purpose of the study is to see if adding inhaled amikacin sulfate for five days can help clear the lung infection more effectively than the usual treatment alone. Participants in the study will receive either the usual treatment or the usual treatment plus inhaled amikacin sulfate. The study will last for a few days, and researchers will check the infection status on the fifth day to see if the bacteria causing the infection have been cleared.

During the study, the researchers will also monitor the participants for any side effects and will measure how well the medications are working in the body. The goal is to find out if the additional treatment with inhaled amikacin sulfate can improve the recovery from the lung infection in patients who are critically ill and receiving ECMO support.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting specific criteria, including being 18 years or older, receiving circulatory support through ECMO for at least 24 hours, and having a confirmed diagnosis of pneumonia caused by gram-negative bacteria.

    Consent is required from the patient or a trusted person if the patient is unable to provide it.

  2. Step 2

    Initial treatment

    Initial treatment involves the administration of antibiotics, specifically piperacillin combined with a beta-lactamase inhibitor, delivered through an intravenous infusion.

    This treatment is part of the standard care for the condition.

  3. Step 3

    Randomization and additional treatment

    Participants are randomly assigned to receive additional treatment with nebulized amikacin for 5 days.

    Amikacin is administered through nasal use, which means it is inhaled directly into the lungs.

  4. Step 4

    Monitoring and assessment

    Throughout the trial, regular assessments are conducted to monitor the bacterial eradication rate, which is the absence of bacteria in samples taken on day 5 after starting the additional treatment.

    Clinical signs of pneumonia and other health indicators are also evaluated to determine the effectiveness of the treatment.

  5. Step 5

    Completion of treatment

    The primary endpoint is assessed on day 5, focusing on the absence of bacteria and improvement in clinical symptoms.

    Secondary endpoints include the analysis of adverse events and the pharmacokinetics of the medications used.

Who can join the trial?

8 criteria

  • Must be **18 years old** or older.
  • Must have been on **ECMO veno-arterial** (a machine that helps with blood circulation and oxygenation) for at least 24 hours before pneumonia is confirmed.
  • Must be on **invasive mechanical ventilation** (a machine that helps with breathing).
  • Must have a **suspicion of pneumonia** based on certain signs like fever over 38.5°C, changes in white blood cell count, thick mucus from the lungs, changes in oxygen levels, or specific findings on lung imaging tests like X-ray, CT scan, or ultrasound.
  • Must have **microbiological confirmation** of pneumonia caused by gram-negative bacteria through specific tests on lung samples.
  • Must be receiving **antibiotic therapy** with a specific medication called piperacillin-tazobactam.
  • Must have given **informed consent** to participate, or consent must be obtained from a trusted person if the patient is unable to consent.
  • Must be **affiliated with a social security scheme** (except AME).

Who cannot join the trial?

5 criteria

  • Patients who are not adults. This means anyone under the age of 18 cannot participate.
  • Patients who are not receiving **Extracorporeal Membrane Oxygenation (ECMO)**. ECMO is a machine that helps the heart and lungs work by pumping blood outside the body to a heart-lung machine.
  • Patients who do not have **Gram-negative bacillus pneumonia**. This is a type of lung infection caused by specific bacteria.
  • Patients who are not on **mechanical ventilation**. This is a machine that helps a person breathe when they cannot do so on their own.
  • Patients who are not receiving **veno-arterial ECMO (VA-ECMO)**. This is a specific type of ECMO that supports both the heart and lungs.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Amikacin: This medication is an antibiotic used to treat serious bacterial infections. In this trial, it is administered through inhalation to help clear lung infections caused by Gram-negative bacteria in patients who are on a specific type of life support called VA-ECMO. The goal is to see if adding inhaled amikacin to the usual antibiotic treatment improves the rate at which the bacteria are eliminated from the lungs.

What is already known about the treatment

Amikacin – This medication is administered through inhalation, specifically as a nebulized form, to treat pneumonia caused by gram-negative bacteria in patients on mechanical ventilation receiving veno-arterial extracorporeal membrane oxygenation (VA-ECMO). Currently, it is being studied in clinical trials to assess its effectiveness in improving bacterial eradication rates when used alongside standard antibiotic therapy. Amikacin is primarily indicated for serious bacterial infections, particularly those caused by gram-negative organisms. It works by binding to bacterial ribosomes, inhibiting protein synthesis, which ultimately leads to the death of the bacteria. Amikacin belongs to the pharmacological class of aminoglycoside antibiotics.

Investigated diseases

Gram-negative Bacillus Pneumonia Acquired During Mechanical Ventilation in Patients Receiving Extracorporeal Membrane Veno-Arterial Oxygenation – This condition occurs when patients on mechanical ventilation, particularly those undergoing veno-arterial extracorporeal membrane oxygenation (VA-ECMO), develop pneumonia caused by gram-negative bacilli. These bacteria can invade the lungs, leading to inflammation and infection. The disease progresses as the bacteria multiply, causing symptoms such as fever, cough, and difficulty breathing. The infection can lead to increased mucus production and impaired gas exchange in the lungs. Over time, if not managed, it can result in further respiratory complications. The condition is often associated with the hospital environment and the use of medical devices like ventilators.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509722-22-00Protocol codeAPHP221166Estimated enrolment26 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).