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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hopital Beaujon	Clichy	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	27.12.2026

Trial locations

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.

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 ID:

2023-509722-22-00

Protocol code:

APHP221166

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?