AuthorisedTherapeutic exploratory (Phase II)Interventional

Nebulized Amikacine for Ventilator associated gram negative Pneumonia in ECMO veno-arterial patients: A randomized Pilot Study (NAVAP-ECMO)

This study, called NAVAP-ECMO, is for seriously ill adults who have a lung infection while on a ventilator and a life support machine called ECMO. We are testing whether giving a common antibiotic, amikacin, directly into the lungs through a nebulizer (like an inhaler) alongside standard IV antibiotics is more effective than standard IV antibiotics alone. The main goal is to see if this new method can get rid of the bacteria causing the lung infection by day 5. We also want to check if patients feel better, if the infection keeps coming back, and if there are any side effects. This is a pilot study, meaning it's an early test to see if this treatment shows promise.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

27 Jun 2024

gram-negative bacillus pneumonia acquired during mechanical ventilation in patients receiving Extracorporeal Membrane veno-arterial oxygenation

What is this study about?

Imagine you're in the hospital and very unwell, needing help to breathe with a machine called a ventilator. Sometimes, despite the best care, patients on ventilators can get serious lung infections, often caused by specific types of bacteria. If these infections are really severe, doctors might decide to use another very important life support machine called ECMO. ECMO helps by taking over the work of your heart and lungs, giving them a chance to rest and heal.

This study, called NAVAP-ECMO, is looking for better ways to treat these difficult lung infections, specifically when they happen in patients who are on both a ventilator and ECMO. We know that standard antibiotics given through a drip (intravenous) sometimes struggle to reach the infection effectively in the lungs. So, this study is exploring if delivering an antibiotic called amikacin directly into the lungs using a nebulizer (a device that turns liquid medicine into a fine mist you can breathe in) can make a difference.

The main aim is to see if this approach can clear up the lung infection more effectively and help patients recover faster. We will compare this new method with the way we usually treat these infections. By doing this, we hope to find a safer and more effective treatment option for very sick patients in the future.

Key takeaways

Study is for very sick adults with lung infections on ventilators and ECMO.
Compares standard antibiotics with standard + inhaled antibiotic (amikacin).
Aims to see if inhaled antibiotic clears infection better.
This is an early-stage study to see if the treatment shows promise.
Close monitoring for infection clearance and safety will occur.

Who may be eligible?

This study is for adults aged 18 and over. It's specifically for those who unfortunately developed a bacterial lung infection while they were on a breathing machine (ventilator) and also receiving advanced life support called ECMO. ECMO is used when your heart and lungs need extra help.

To be considered for this study, your doctors would need to confirm that you have this specific type of lung infection and that you are currently receiving care with both a ventilator and ECMO.

Other health conditions or medications might affect whether you can join, but your care team will carefully check all the details to make sure the study is a good fit for you and safe.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a bacterial lung infection?
Are you currently on a breathing machine (ventilator)?
Are you also receiving life support called ECMO?

Answer every question to see your result.

What does participation involve?

If you or your loved one were to take part in this study, you would continue to receive the best possible care from your medical team. The study involves a close look at how well the lung infection responds to treatment.

Some patients would receive standard antibiotics through a vein (like a drip), which you would already be getting. Other patients would receive these standard antibiotics PLUS the study antibiotic, amikacin, delivered as a mist directly into the lungs through a nebulizer. This nebulizer treatment would be given for a few days.

Your doctors would take samples from your lungs (called a tracheal aspirate) on specific days to see if the bacteria are still present. They will also continually monitor your overall health, including lung function, and watch carefully for any side effects. The study also involves collecting blood samples to check how the antibiotics are working in your body. All of these procedures are standard care for critically ill patients, and participation would mean these tests are conducted on specific research timelines.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that the new way of giving antibiotics directly to the lungs might help clear your infection more effectively than standard treatment alone. This could potentially lead to a faster recovery or more successful treatment of the resistant bacteria. However, this is not guaranteed, and the study is designed to find out if it works. Potential risks include possible side effects from the study medication, although amikacin is a known antibiotic. Your medical team will carefully monitor you for any adverse reactions throughout the study. Remember, participating in a clinical trial is always voluntary, and you are free to withdraw at any time without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is ECMO?

ECMO is a machine that does the work of your heart and lungs, giving them time to rest and heal when they are too sick to function on their own.

What is a nebulizer?

A nebulizer is a device that turns liquid medicine into a fine mist that you can breathe directly into your lungs.

What does 'gram-negative bacillus pneumonia' mean?

It's a serious type of lung infection caused by specific kinds of bacteria that can be difficult to treat.

Is this a new medicine?

No, amikacin is a known antibiotic. This study is testing a new way of giving it (directly into the lungs) for this specific condition.

Will I definitely get the new treatment?

Because it's a 'randomized' study, you would be put into a group by chance – either receiving the inhalable antibiotic plus standard care, or just standard care.