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

NCT01996579 | Completed Phase 2

• 1 other identifier: DMED-1569-13
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critically Ill

Keywords

Critically Ill; Intensive care; Nasogastric tube; Orogastric tube; mechanically ventilated; nosocomially acquired infections; length of stay; lactoferrin; placebo controlled; antibiotic free days

Outcome Measures

Primary Outcomes (1)

• Antibiotic free days.

  Alive and free of antibiotics in the 28 days after study enrollment. These data will inform a future large scale Phase 3 RCT powered on clinically important outcomes such as mortality.

  28 Days after study enrollment.

Secondary Outcomes (1)

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

  90 days post study enrollment.

Other Outcomes (2)

• Occurence of nosocomial infections.

  28 days post study enrollment.

• Immunological competence.

  Baseline, Day 7, 14, 21 or 28 post study enrollment or ICU discharge.

Study Arms (2)

Lactoferrin

EXPERIMENTAL

Patients 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.

Dietary Supplement: Lactoferrin

Placebo (sterile water)

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Lactoferrin DIETARY_SUPPLEMENT

Lactoferrin 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.

Lactoferrin

Placebo OTHER

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

Also known as: Sterile water

Placebo (sterile water)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\>18 years old)
• Duration of mechanical ventilation \< 48 hours and
• Expected duration of mechanically ventilation \> 72 hours.

You may not qualify if:

• 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).
• The presence of a contra-indication to enteral feeding.
• Lack of access to the oral cavity.
• Allergy or sensitivity to Lactoferrin or bovine derived proteins or bovine milk
• Immunocompromised patients (post-organ transplantation, Acquired Immunodeficiency Syndrome \[AIDS\], neutropenia \[\<1000 absolute neutrophils\], corticosteroids \[\>20 mgs/day of prednisone or equivalent for more than 6 months\])
• Patients with fulminant liver failure or end stage liver disease (Child's Class C)
• Life expectancy, due to pre-existing conditions such as cancer, is less than six months.
• Women who are pregnant or lactating.
• 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).
• Prior randomization in this study.

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Lactoferrin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Officials

• John G Muscedere, MD

  Queen's University, Kingston General Hosptial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. John G. Muscedere, MD, FRCPC

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 27, 2013
• Study Start: November 1, 2013
• Primary Completion: September 12, 2016
• Study Completion: September 12, 2016
• Last Updated: February 20, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)