Probiotics to Actively Counter Ventilator Associated Pneumonia (PROACT)

Launched by UNIVERSITY OF BARI · Oct 15, 2023

Keywords

ClinConnect Summary

The PROACT study is researching whether giving probiotics—beneficial bacteria that can improve gut health—can help prevent a lung infection called ventilator-associated pneumonia (VAP) in patients who are on mechanical ventilation in the ICU. This trial is looking for adults aged 18 to 80 years who have had a serious head injury or a stroke without any signs of lung infection. Participants will be randomly assigned to receive either probiotics or a placebo (a treatment that looks the same but has no active ingredients) to see if the probiotics can reduce the risk of VAP and improve survival rates.

If you or a loved one are eligible, you can expect to be involved in a study where you will receive either the probiotic treatment or a placebo during your time on the ventilator, which is expected to last at least six days. The study is currently recruiting participants, and anyone interested will need to provide written consent before joining. It's important to note that there are specific health conditions that may exclude someone from participating, such as severe immune system issues or certain heart problems. Overall, this trial aims to gather important information that could help shape future guidelines for preventing lung infections in critically ill patients.

Gender

ALL

Eligibility 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