Actively Recruiting
Probiotics to Actively Counter Ventilator Associated Pneumonia (PROACT)
Led by University of Bari · Updated on 2025-09-23
186
Participants Needed
9
Research Sites
135 weeks
Total Duration
On this page
Sponsors
U
University of Bari
Lead Sponsor
U
Uni-Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Probiotics to Actively Counter Ventilator Associated Pneumonia (PROACT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-80 years
- Recent trauma involving head injury plus at least one other organ system, or stroke or brain hemorrhage without signs of aspiration or lung infection
- Intubated and started mechanical ventilation immediately after the event (ambulance or emergency department for head trauma)
- Expected to require mechanical ventilation for at least six days
- Written informed consent provided by patient or legal representative
You will not qualify if you...
- Mechanical ventilation for more than 72 hours before screening
- Pregnancy or breastfeeding
- Immunosuppression including HIV with CD4 count below 200 cells/µL
- Use of chronic immunosuppressive drugs such as azathioprine, cyclosporine, cyclophosphamide, tacrolimus, methotrexate, mycophenolate, or Anti-IL2
- Previous organ transplantation
- Recent chemotherapy within 3 months for cancer
- Neutropenia with absolute neutrophil count below 500
- Severe pancreatitis (Ranson score 3 or higher)
- Ischemic bowel disease
- Injury to oropharyngeal mucosa
- Unable to receive medications by mouth or feeding tube
- Planned withdrawal of advanced life support by ICU doctor
- Risk of endovascular infection due to conditions like rheumatic heart disease, congenital valve disease, prosthetic heart valves, previous or current endocarditis, permanent endovascular devices, tunnelled hemodialysis catheters, pacemakers, or defibrillators
- Patients with sepsis or septic shock
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Hospital Erasme
Brussels, Belgium
Actively Recruiting
2
Regional General Hospital F. Miulli
Acquaviva delle Fonti, BA, Italy
Actively Recruiting
3
Intensive Care Unit, Policlinico di Bari
Bari, BA, Italy
Actively Recruiting
4
Azienda Ospedaliero Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Actively Recruiting
5
Ospedale Di Venere
Bari, Italy, 70131
Actively Recruiting
6
AUSL Bologna Ospedale Bellaria
Parma, Italy
Actively Recruiting
7
Azienda Ospedaliero Universitaria di Parma
Parma, Italy
Actively Recruiting
8
Azienda Ospedaliera di Perugia
Perugia, Italy
Actively Recruiting
9
Azienda ospedaliera Santa Maria di Terni
Terni, Italy
Actively Recruiting
Research Team
A
Alberto Corriero, MD
CONTACT
F
Filomena Puntillo, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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