NCT00377078

Brief Summary

Primary objective of this pilot study is to evaluate the effect of recombinant human lactoferrin on the rate of infection with Clostridium difficile in long-term care patients supported by enteral feeding requiring broad spectrum antibiotics.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

September 15, 2006

Status Verified

September 1, 2006

First QC Date

September 14, 2006

Last Update Submit

September 14, 2006

Conditions

Clostridium Difficile

Keywords

recombinant human lactoferrin

Outcome Measures

Primary Outcomes (2)

  • Subjects receive 3 grams of lactoferrin in a flush solution for the automated enteric feeding system.

  • Dosing will begin with antibiotic dosing

Interventions

recombinant human lactoferrinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients in long-term care facility, Ventilator Rehabilitation Unit (VRU) (Plaza) at the John Burton Care Center of the Johns Hopkins Bayview Medical Center.
  • Nutrition via gastrostomy, naso-gastric or jejunostomy enteral feeding system.
  • Patients with supplemental oral intake, but primary nutrition via gastrostomy/jejunostomy tube.
  • Patients with colostomies are also allowed
  • Not currently on antibiotic therapy and no antibiotics within 10 days.
  • Patient is negative for Clostridium difficile antigen in screen
  • Patient, guardian or health care agent willing to give informed consent.

You may not qualify if:

  • Patients who will only receive vancomycin, linezolid, or metronidazole as the antibiotic treatment, not broad spectrum antibiotics. All other antibiotics will qualify.
  • Patients with illeostomies.
  • Patients who have signs or symptoms of C. difficile infection; such as diarrhea (two or more liquid stools in a 24-hour period) and elevated WBC (more than 15,000/mm3).
  • Known allergy to rice or rice products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

RECRUITING

Study Officials

  • William B Greenough, III, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

  • Delia Bethell, Ph.D.

    Ventria Bioscience

    STUDY DIRECTOR

  • Delia Bethell, Ph.D.

    Ventria Bioscience

    STUDY CHAIR

Central Study Contacts

William B Greenough, III, MD

CONTACT

410-550-0782trigsby@jhmi.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2006

First Posted

September 15, 2006

Study Start

October 1, 2005

Study Completion

October 1, 2007

Last Updated

September 15, 2006

Record last verified: 2006-09

Locations

US(1)