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RECRUITINGINTERVENTIONAL

Probiotics to Actively Counter Ventilator Associated Pneumonia (PROACT)

Probiotics in ICU to Reduce Ventilator-Associated Pneumonia: A Double-blind Multicentre Randomized Clinical Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form provided by the patient or legal representative Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIETARY_SUPPLEMENT

LactoLevure

Patients will receive two capsules, twice daily for 30 days, one through the nasogastric tube and one spread on the oropharynx. The probiotic capsules look identical to the placebo capsules; the powder will be similar when opened. The capsule for nasogastric tube will be opened and suspended in 100 ml of tap water. The capsule for the oropharynx will be opened and suspended in sterile water based surgical lubricant. The administration must happen at least 30 minutes after oral antiseptic product usage (e.g. daily chlorhexidine oral care), which otherwise might neutralize the study supplement's action.

OTHER

Placebo

Patients will receive two capsules, twice daily for 30 days, one through the nasogastric tube and one spread on the oropharynx. The placebo capsules contain a powdered glucose polymer that is unharmful for the patient and will be provided by the sponsor. The placebo capsules look identical to the probiotic capsules; the powder will be similar when opened. The capsule for nasogastric tube will be opened and suspended in 100 ml of tap water. The capsule for the oropharynx will be opened and suspended in sterile water based surgical lubricant. The administration must happen at least 30 minutes after oral antiseptic product usage (e.g. daily chlorhexidine oral care), which otherwise might neutralize the study supplement's action.

Locations (9)

Hospital Erasme
Brussels, Belgium
Regional General Hospital F. Miulli
Acquaviva delle Fonti, BA, Italy
Intensive Care Unit, Policlinico di Bari
Bari, BA, Italy
Azienda Ospedaliero Universitaria di Alessandria SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Ospedale Di Venere
Bari, Italy
AUSL Bologna Ospedale Bellaria
Parma, Italy
Azienda Ospedaliero Universitaria di Parma
Parma, Italy
Azienda Ospedaliera di Perugia
Perugia, Italy
Azienda ospedaliera Santa Maria di Terni
Terni, Italy