Using probiotics to prevent pneumonia in ICU patients on ventilators
Probiotics in ICU to Reduce Ventilator-Associated Pneumonia: A Double-blind Multicentre Randomized Clinical Trial
This study tests if giving probiotics to ICU patients on ventilators can help prevent pneumonia and improve their chances of recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 186 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Bari Academic / other |
| Drugs / interventions | chemotherapy, methotrexate, cyclophosphamide |
| Locations | 9 sites (Brussels and 8 other locations) |
| Trial ID | NCT06092554 on ClinicalTrials.gov |
What this trial studies
The PROACT study investigates the effectiveness of probiotics in preventing ventilator-associated pneumonia (VAP) in multi-trauma patients with head injuries or strokes. Participants will be randomly assigned to receive either a probiotic treatment or a placebo while on mechanical ventilation. The study aims to determine if probiotics can reduce the incidence of VAP and mortality rates in these high-risk patients. This approach is based on previous literature suggesting that probiotics may lower VAP rates, particularly in trauma patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with recent trauma involving head injury or stroke, requiring mechanical ventilation for at least six days.
Not a fit: Patients who have been on mechanical ventilation for more than 72 hours or those with immunosuppression may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new preventive treatment for VAP, potentially reducing mortality rates in critically ill patients.
How similar studies have performed: Previous studies have shown promising results with probiotics in reducing VAP in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 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 Criteria:
* 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
1. previously documented rheumatic heart disease, congenital valve disease, surgically repaired congenital heart disease, unrepaired cyanotic congenital heart disease, any intracardiac repair with prosthetic material \[mechanical or bioprosthetic cardiac valves\]
2. previous or current endocarditis
3. 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
4. tunnelled (not short-term) hemodialysis catheters
5. 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
Where this trial is running
Brussels and 8 other locations
- Hospital Erasme — Brussels, Belgium (Recruiting)
- Regional General Hospital F. Miulli — Acquaviva delle Fonti, Ba, Italy (Recruiting)
- Intensive Care Unit, Policlinico di Bari — Bari, Ba, Italy (Recruiting)
- Azienda Ospedaliero Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo — Alessandria, Italy (Recruiting)
- Ospedale Di Venere — Bari, Italy (Recruiting)
- AUSL Bologna Ospedale Bellaria — Parma, Italy (Recruiting)
- Azienda Ospedaliero Universitaria di Parma — Parma, Italy (Recruiting)
- Azienda Ospedaliera di Perugia — Perugia, Italy (Recruiting)
- Azienda ospedaliera Santa Maria di Terni — Terni, Italy (Recruiting)
Study contacts
- Principal investigator: Alberto Corriero, MD — University of Bari
- Study coordinator: Alberto Corriero, MD
- Email: alberto.corriero@gmail.com
- Phone: +393280072443
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.