Not yet recruitingPHASE4INTERVENTIONAL

Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Therapy in Critically Ill Patients With Ventilator-associated Pneumonia

This study is for very sick patients who develop pneumonia while on a breathing machine (ventilator) in hospital, an infection known as Ventilator Associated Pneumonia (VAP). Researchers want to see if using a new, fast test, called a respiratory multiplex PCR, combined with a special guide (algorithm), helps doctors choose the right antibiotics more quickly. This new approach is being compared to the usual way doctors decide on treatment. The main goal is to find out if the new method leads to doctors optimising antibiotic treatment earlier, which could improve how well patients respond.

At a glance

Status

Not yet recruiting

Phase

PHASE4

Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrolment target

124

Start

01 Jun 2026

Estimated completion

31 Jul 2026

Ventilator Associated Pneumonia ( VAP)

What is this study about?

Imagine you're very unwell in hospital and need a machine to help you breathe. Sometimes, people can get a lung infection called pneumonia when they're on this breathing machine, which doctors call Ventilator Associated Pneumonia or VAP. This infection needs to be treated quickly and effectively with the right antibiotics.

Doctors often have to guess which antibiotic will work best at first, while they wait for lab test results that can take time. These tests help them identify the specific germ causing the infection and which antibiotics will kill it. This study is exploring a new way to help doctors make quicker, more informed decisions about antibiotics.

The study involves comparing two approaches: the usual way doctors choose antibiotics, and a new way that combines a very fast lab test (called a respiratory multiplex PCR) with a special treatment guide. This fast test can identify many different germs at once, much quicker than standard tests. The aim is to see if using this fast test and guide helps doctors switch to the most effective antibiotic sooner, which could be better for patients.

Key takeaways

Study compares new fast testing for pneumonia on breathing machines.
Aims to help doctors choose the best antibiotics sooner.
Two groups: new approach (fast test + guide) vs. standard care.
Participation involves a deep lung sample, which is a standard procedure.
You can withdraw at any time without affecting your medical care.

Who may be eligible?

This study is for adults aged 18 or over who are currently in hospital on a breathing machine and have developed pneumonia (VAP). To be considered, you would need to have certain symptoms of pneumonia, such as a fever or a new cough, along with changes in your lungs seen on a scan.

There are some reasons why you might not be able to join. For example, if you are pregnant, have certain conditions affecting your immune system (like HIV in some cases, or recent cancer treatment), or are taking strong medications that suppress your immune system (such as high-dose steroids). If you have a known severe allergy to certain antibiotics called beta-lactams, or if doctors think your underlying illness is very severe and likely to lead to death soon, you also wouldn't be able to take part. Also, if you're taking part in another clinical trial, you wouldn't be eligible for this one.

Importantly, a deep breathing sample (taken from your lungs) would need to be collected within 12 hours of being considered for the study.

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?
Are you currently on a breathing machine in hospital with suspected pneumonia?
Do you have certain pneumonia symptoms like fever or changes in your lungs?
Do you have a healthy immune system or no recent immune-suppressing treatments?
Are you not pregnant and not part of another research study?

Answer every question to see your result.

What does participation involve?

If you take part in this study, after doctors suspect you have pneumonia, a special deep breathing sample will be taken from your lungs. This is usually done using a small tube that goes into your airways to collect a sample. This procedure will happen regardless of which group you are in. You will then be randomly assigned to one of two groups.

In both groups, you will receive initial antibiotic treatment based on what your doctors think is best, and your lung sample will be sent for standard lab tests. These tests help identify the specific germ causing your infection and which antibiotics will work. If you are in the 'new approach' group, your lung sample will also undergo an extra, very fast test. The results from this fast test will be available much quicker, helping your doctors adjust your antibiotics sooner if needed, using a special guide. If you are in the 'usual care' group, your doctors will adapt your antibiotics based on the standard lab tests when they become available. The study does not involve extra visits or follow-ups beyond your usual hospital care. The total duration of your participation would be during your hospital stay related to this pneumonia.

Potential risks and benefits

The main benefit of taking part is that, if you are in the new approach group, your doctors might be able to find the best antibiotic for you more quickly, which could help you recover better. However, there's no guarantee this will happen. The main risk involves the procedure to collect the deep breathing sample, which carries small risks like discomfort or bleeding, but this is a standard procedure for diagnosing pneumonia in severely ill patients. Your doctors will make sure this procedure is safe for you. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

CHU Nîmes
Verified postcode
Nîmes, France

Common questions

What is 'Ventilator Associated Pneumonia'?

It's a type of pneumonia, a lung infection, that can happen to very sick patients who are on a breathing machine (ventilator) in the hospital.

What is this new 'fast test'?

It's a quick lab test that can identify many different germs in your lung sample much faster than traditional methods, helping doctors choose antibiotics sooner.

Will I automatically get the new treatment if I join?

No, you will be randomly assigned to either receive care with the new fast test and guide, or the standard care approach. The choice is made by chance.

Will my care change if I decide not to join the study?

No, your medical care will be exactly the same whether you decide to join the study or not. Your decision will not affect your treatment.

Is the procedure to take the lung sample safe?

Yes, taking a deep breathing sample is a standard medical procedure for diagnosing serious lung infections. Your medical team will ensure it's done as safely as possible.

How to find out more

Hugo MARTINIERE, PH

hugo.martiniere@chu-nimes.fr +33 4 66 68 33 31 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.