Status:
RECRUITING
Probiotics to Actively Counter Ventilator Associated Pneumonia (PROACT)
Lead Sponsor:
University of Bari
Collaborating Sponsors:
Uni-Pharma
Conditions:
Ventilator Associated Pneumonia
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Ventilator-associated pneumonia represents a burden in ICU with a mortality rate approaching 50%. Ventilator-associated pneumonia (VAP) reduction care bundle is a grouping of evidence-based, high-impa...
Eligibility Criteria
Inclusion
- 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 inclusion criteria (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
Exclusion
- 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 \[mechanical or bioprosthetic cardiac valves\]
- 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 (CABG), or neurovascular coils are not excluded, nor are patients with mitral valve prolapse or bicuspid aortic valve if they do not meet any other exclusion criteria.
- patients with sepsis and/or septic shock
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2026
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT06092554
Start Date
December 13 2023
End Date
July 15 2026
Last Update
September 23 2025
Active Locations (9)
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1
Hospital Erasme
Brussels, Belgium
2
Regional General Hospital F. Miulli
Acquaviva delle Fonti, BA, Italy
3
Intensive Care Unit, Policlinico di Bari
Bari, BA, Italy
4
Azienda Ospedaliero Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy