Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02462590
• Date of registration: 02/06/2015
• Prospective Registration: No
• Primary sponsor: McMaster University
• Public title: Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial PROSPECT
• Scientific title: Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT)
• Date of first enrolment: June 2015
• Target sample size: 2650
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02462590
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Canada, Saudi Arabia, United States

Contacts

• Name: Nicole Zytaruk

• Name: Deborah J Cook, MD
• Affiliation: McMaster University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Adults = 18 years of age

2. Admitted to any ICU and receiving invasive mechanical ventilation

3. Anticipated ventilation of =72 hours at the time of screening, as per the ICU
physician.

Exclusion Criteria:

1. Invasively mechanically ventilated >72 hours at the time of screening;

2. Patients at potential increased risk of iatrogenic probiotic infection (see Section
2.6 for detailed explanation) including specific immunocompromised populations (HIV
<200 CD4 cells/µL, those receiving chronic immunosuppressive medications (e.g.,
azathioprine, cyclosporine, cyclophosphamide, tacrolimus, methotrexate, mycofenolate,
Anti-IL2), previous transplantation (including stem cell) at any time, malignancy
requiring chemotherapy in the last 3 months, neutropenia [absolute neutrophil count <
500]). However, patients receiving corticosteroids previously or presently or
projected to receive corticosteroids are not excluded;

3. Patients at risk for endovascular infection (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 bio-prosthetic 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
temporary central venous catheters, central venous dialysis catheters or peripherally
inserted central catheters (PICCs) are not excluded and patients with coronary artery
stents, coronary artery bypass grafts (CABG) or neurovascular coils are not excluded;
patients with mitral valve prolapse or bicuspid aortic valve are not excluded
providing they have no other exclusion criteria;

4. Patients with a primary diagnosis of severe acute pancreatitis, without reference to a
Ranson score [Ranson 1974]). However, patients with mild or moderate pancreatitis are
not excluded;

5. Patients with percutaneous gastric or jejunal feeding tubes already in situ as per
Health Canada guidance;

6. Strict contraindication or inability to receive enteral medications;

7. Intent to withdraw advanced life support as per the ICU physician;

8. Previous enrolment in this or current enrolment in a potentially confounding tria



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Infections

Ventilator Associated Pneumonia

Antibiotic-associated Diarrhea

C-Difficile

Diarrhea

Intervention(s)

Drug: L. rhamnosus GG - Probiotic

Drug: Placebo - Microcrystalline Cellulose

Primary Outcome(s)

Number of patients with Ventilator Associated Pneumonia (VAP) [Time Frame: 60 Days]

Secondary Outcome(s)

Defined Daily Dose Antibiotic Exposure [Time Frame: 60 Days]

Duration of mechanical ventilation [Time Frame: 60 Days]

Number of patients with infections acquired during the ICU stay [Time Frame: 60 Days]

Number of patients with antibiotic-associated diarrhea [Time Frame: 60 Days]

Number of patients with Clostridium Difficile-associated diarrhea [Time Frame: 60 Days]

Number of patients with diarrhea [Time Frame: 60 Days]

ICU mortality and in-hospital mortality: [Time Frame: 60 Days]

Secondary ID(s)

27022015

Source(s) of Monetary Support

Please refer to primary and secondary sponsors