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Perpetual Observational Study - Ventilator Associated Pneumonia

This study focuses on ventilator-associated pneumonia (VAP), a serious lung infection that can affect patients in intensive care units (ICU) who need a breathing machine. VAP makes patients sicker, can lead to longer hospital stays, and sometimes even death. Doctors are developing new ways to prevent and treat VAP, but they need to be properly tested. This study isn't about testing a new treatment right now. Instead, its main goal is to build a strong, reliable network of ICUs across different hospitals. This network will be ready and prepared to run future studies that test these new treatments and preventative measures more quickly and efficiently, ultimately helping patients get better care.

At a glance

Status
Recruiting
Sponsor
European Clinical Research Alliance for Infectious Diseases (ECRAID)
Enrolment target
20,000
Start
03 Aug 2022
Estimated completion
01 Mar 2027

What is this study about?

When patients are very ill and need help breathing, they might be put on a breathing machine (called a ventilator) in the intensive care unit (ICU). Sometimes, these patients can develop a serious lung infection called Ventilator-Associated Pneumonia, or VAP. This infection can make them much sicker, lead to longer stays in hospital, and sadly, can sometimes be life-threatening. It also means more antibiotics are used, which isn't always ideal.

Researchers and doctors are working hard to find better ways to stop VAP from happening and to treat it when it does. Before these new approaches can be widely used, they need to be thoroughly tested in carefully designed studies called clinical trials. These trials need a lot of patients and dedicated hospitals to take part.

This particular study, called the Perpetual Observational Study on VAP (POS-VAP), isn't testing a new treatment itself. Instead, it's setting up the groundwork for future trials. It aims to create and keep a strong, well-organised group of ICUs in different hospitals. This network will make it easier and quicker to run the important trials needed to find the best ways to prevent and treat VAP, so that patients can get better care sooner.

Key takeaways

  • This study aims to understand lung infections in very sick patients on breathing machines.
  • It helps prepare hospitals for future trials of new VAP treatments.
  • No new medicines or treatments are given in this study.
  • Your treatment will not change by taking part.
  • The study helps improve future care for patients with VAP.
  • You can stop participating at any time.

Who may be eligible?

To be considered for taking part in this study, you would need to be aged 18 or over. You would also need to be in or coming into intensive care and expected to be on a breathing machine for more than two days. This includes patients who are at risk of getting VAP.

The study also needs your agreement to take part. This usually means you would need to be able to understand the study and give your written consent. If you're too unwell to do this, a close family member or legal representative might be able to give consent on your behalf, if allowed by local rules. Sometimes, if immediate care is needed, information might be collected before formal consent can be given, following specific rules.

You would not be able to join if your doctors believe you are very close to the end of your life and you (or your family) are not committed to receiving all available medical treatments.

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.

  1. Are you 18 years old or older?
  2. Are you in or coming into intensive care?
  3. Are you expected to be on a breathing machine for more than two days?
  4. Are you (or a family member) able to give consent to join the study?
Answer every question to see your result.

What does participation involve?

This study is an 'observational study'. This means it mainly involves collecting information from patients already receiving care in intensive care units. You would not be given any new or experimental treatments as part of this study. There are no extra hospital visits, specific assessments, or follow-up appointments required solely for this study. It's about collecting data from your routine medical care to help researchers understand VAP better and prepare for future studies. The total duration of your participation would be for the period you are in intensive care and on a breathing machine, as relevant to the study's data collection.

Potential risks and benefits

Taking part in this study does not involve any direct medical risks, as you won't be receiving any new medications or procedures specifically for the study. The main benefit for you would be helping researchers learn more about ventilator-associated pneumonia (VAP) and contribute to building a network that will make it easier to test new treatments in the future. This could lead to better care for patients like you down the line. You always have the right to withdraw from the study at any time without it affecting your medical care.

Locations (35)

  • University Hospital of Trauma
    Verified postcode
    Tirana, Albania· Recruiting
  • Cliniques Universitaires Saint-Luc UCL
    Verified postcode
    Brussels, Belgium· Recruiting
  • Universitair Ziekenhuis Gent
    Verified postcode
    Ghent, Belgium· Recruiting
  • Hôpital de Jolimont
    Verified postcode
    La Louvière, Belgium· Recruiting
  • Centre Hospitalier Universitaire de Liège
    Verified postcode
    Liège, Belgium· Not yet recruiting
  • Clinique Saint Pierre Ottignies
    Verified postcode
    Ottignies-Louvain-la-Neuve, Belgium· Active not recruiting
  • Clinical Hospital Center Rijeka
    Verified postcode
    Rijeka, Croatia· Recruiting
  • General Hospital "Dr. Josip Benčević" Slavonski Brod
    Verified postcode
    Slavonski Brod, Croatia· Recruiting
  • University Hospital for Infectious Diseases
    Verified postcode
    Zagreb, Croatia· Not yet recruiting
  • University Hospital Kralovske Vinohrady
    Verified postcode
    Brno-Vinohrady, Czechia· Recruiting
  • University Hospital Motol
    Verified postcode
    Prague, Czechia· Recruiting
  • Centre Hospitalier William Morey
    Verified postcode
    Chalon-sur-Saône, France· Recruiting

Common questions

What is VAP?

VAP stands for Ventilator-Associated Pneumonia. It's a lung infection that can affect patients in intensive care who are on a breathing machine.

Is this study testing a new medicine?

No, this study is not testing a new medicine or treatment. It's collecting information to help set up future studies that will test new treatments.

Will my treatment change if I join this study?

No, your medical treatment will not change because you are part of this study. You will continue to receive the best care recommended by your doctors.

What information will the study collect about me?

The study will collect information about your health, your time in intensive care, and how you respond to existing treatments for VAP, from your routine medical records.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it will not affect the medical care you receive.

How to find out more

Bruno FRANCOIS, MD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Perpetual Observational Study - Ventilator Associated Pneumo…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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