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New treatment option for Ventilator Associated Pneumonia
Official title Probiotics to Actively Counter Ventilator Associated Pneumonia (PROACT)
ClinicalTrials.gov ID: NCT06092554
What this study is testing
- What it's testing
- PROACT study aims to resolve uncertainties to influence actual practice guidelines or public health policing regarding VAP prevention in ICU by using probiotics administration. Multi-trauma patients with a head injury OR stroke or brain haemorrhage patients without any sign of aspiration and lung infection will be enrolled and randomized to either placebo or probiotic treatment to assess if VAP and mortality can be reduced in the interventional group.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- adults aged 18-80 years
- at least one of the following conditions: a) recent trauma involving head injury and at least one more organ system; b) stroke or brain hemorrhage...
- intubation and start of mechanical ventilation. This needs to start immediately after the event described in the (b). For cases of head trauma this...
- likelihood that the duration of mechanical ventilation would be at least six days
- written informed consent provided by the patient or legal representative
You likely can't join if
- has received mechanical ventilation more than 72 hours from start of screening
- pregnancy or Lactation
- patients at risk of iatrogenic probiotic infection e.g. immunosuppression which includes
- HIV \<200 CD4 cells/μL
- those receiving chronic immunosuppressive medications (e.g., azathioprine, cyclosporine, cyclophosphamide, tacrolimus, methotrexate, mycofenolate...
- previous transplantation at any time
See the full eligibility criteria
- adults aged 18-80 years
- at least one of the following conditions: a) recent trauma involving head injury and at least one more organ system; b) stroke or brain hemorrhage without any sign of aspiration and lung infection
- intubation and start of mechanical ventilation. This needs to start immediately after the event described in the (b). For cases of head trauma this is defined as start in the ambulance or the emergency department
- likelihood that the duration of mechanical ventilation would be at least six days
- written informed consent provided by the patient or legal representative
- has received mechanical ventilation more than 72 hours from start of screening
- pregnancy or Lactation
- patients at risk of iatrogenic probiotic infection e.g. immunosuppression which includes
- HIV \<200 CD4 cells/μL
- those receiving chronic immunosuppressive medications (e.g., azathioprine, cyclosporine, cyclophosphamide, tacrolimus, methotrexate, mycofenolate, Anti-IL2)
- previous transplantation at any time
- malignancy requiring chemotherapy in the last 3 months
- neutropenia [absolute neutrophil count \< 500])
- patients with a primary diagnosis of severe pancreatitis (Ranson score of 3 or more). Mild and moderate pancreatis is not excluded
- ischemic bowel disease
- oropharyngeal mucosal injury
- inability to receive enteral medications
- intent to withdraw advanced life support as per ICU doctor in charge
- patients at risk of endovascular infection which includes
- previously documented rheumatic heart disease, congenital valve disease, surgically repaired congenital heart disease, unrepaired cyanotic congenital heart disease, any intracardiac repair with prosthetic material...
- previous or current endocarditis
- permanent endovascular devices (e.g., endovascular grafts [e.g., aortic aneurysm repair, stents involving large arteries such as aorta, femorals and carotids] inferior vena cava filters, dialysis vascular grafts
- tunnelled (not short-term) hemodialysis catheters
- pacemakers or defibrillators Patients with peripherally inserted central catheters (PICCs), temporary central venous catheters, central venous dialysis catheters, coronary artery stents, coronary artery bypass grafts...
- patients with sepsis and/or septic shock
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Acquaviva delle Fonti, BA, Italy
- Bari, BA, Italy
- Alessandria, Italy
- Bari, Italy
- Parma, Italy
- Perugia, Italy
- Terni, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Acquaviva delle Fonti, BA, Italy; Bari, BA, Italy; Alessandria, Italy; Bari, Italy; Parma, Italy and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.