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Critically Ill | Prevention of Nosocomial Infections in Critically Ill Patients With Lactoferrin: The PREVAIL Study

Critically Ill research study

What is the primary objective of this study?

Lactoferrin is a protein that is a component of the immune system. It has many properties that could make it the ideal agent for the prevention of hospital-acquired infections. Lactoferrin has antibacterial properties (is able to kill or stop the growth of disease causing bacteria and fungal organisms), it improves immune function, and can increase the growth of beneficial bacteria in the bowel. Lactoferrin has been approved by Health Canada as a Natural Health product and is sold in health food stores as a supplement. However, given the potential beneficial effects of Lactoferrin, it requires further study as to its effects in acutely and seriously ill patients. One potential use which has not been studied is for the prevention of infections in critically adult ill patients. The aim of this study is to determine the utility of Lactoferrin in this patient population. The Lactoferrin that the investigators will be using in this study is extracted from cow's milk, where it naturally occurs. Cow lactoferrin has similar properties as that normally produced in the human body. This study is being conducted to determine how well a solution of Lactoferrin given orally and through a feeding tube helps to prevent infections and inflammation in critically ill patients in addition to usual care and other measures that are known to be partially effective for the prevention of infections.

Who is eligible to participate?

Inclusion Criteria: 1. Adult patients (>18 years old) 2. Duration of mechanical ventilation < 48 hours and 3. Expected duration of mechanically ventilation > 72 hours. Exclusion Criteria: 1. Patients not expected to be in ICU for more than 72 hours from time of randomization (due to imminent death, withdrawal of aggressive care or discharge). 2. The presence of a contra-indication to enteral feeding. 3. Lack of access to the oral cavity. 4. Allergy or sensitivity to Lactoferrin or bovine derived proteins or bovine milk 5. Immunocompromised patients (post-organ transplantation, Acquired Immunodeficiency Syndrome [AIDS], neutropenia [<1000 absolute neutrophils], corticosteroids [>20 mgs/day of prednisone or equivalent for more than 6 months]) 6. Patients with fulminant liver failure or end stage liver disease (Child's Class C) 7. Life expectancy, due to pre-existing conditions such as cancer, is less than six months. 8. Women who are pregnant or lactating. 9. Enrollment in industry sponsored interventional trial (co-enrollment in other academic studies would be allowed with the proviso that there was no potential interaction between the protocols). 10. Prior randomization in this study.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Critically Ill

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Dietary Supplement:LactoferrinLactoferrin is an 80 kilodalton (kD) naturally occurring multifunctional glycoprotein of the transferrin family which is an important component of the human innate immune system. Lactoferrin is distributed widely in humans with the main sources of production being exocrine glands and specific granules of neutrophils. It is present in virtually all human secretions. The highest concentrations are found in milk and colostrum. Lactoferrin has multiple biological functions which make it of interest as a therapeutic agent in the critically ill. These include the ability to bind iron, antimicrobial activity including antibacterial, antifungal, antiviral properties, the ability to bind endotoxin, promotion of beneficial bacteria in the gastro-intestinal tract and immunomodulatory activity.

Other:PlaceboSterile water will be utilized as the placebo control in this double blind randomized-controlled trial.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

LactoferrinPatients randomized to the Lactoferrin arm will receive Lactoferrin delivered to the oral cavity as a mouth swab and Lactoferrin down a nasogastric tube; a total of 2 grams administered in 4 divided doses per day.

Placebo (sterile water)Placebo (sterile water) will also be delivered down the nasogastric tube; administered in 4 divided doses per day.

Study Status

Completed

Start Date: November 2013

Completed Date: September 12, 2016

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Antibiotic free days.

Secondary Outcome: Feasibility of conducting a Phase 3 study powered on clinically important outcomes such as mortality, length of stay and duration of mechanical ventilation.

Study sponsors, principal investigator, and references

Principal Investigator: John G Muscedere, MD

Lead Sponsor: Queen's University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01996579

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