Use of Recombinant Human Lactoferrin in Long-Term Care Patients With Feeding Tubes With Clostridium Difficile.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ventria Bioscience
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00377078
First received: September 14, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Clostridium Difficile
Drug: recombinant human lactoferrin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Use of Recombinant Human Lactoferrin in Long-Term Care Patients With Feeding Tubes to Manage Post-Antibiotic Colonization and Infection With Clostridium Difficile

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Subjects receive 3 grams of lactoferrin in a flush solution for the automated enteric feeding system.
  • Dosing will begin with antibiotic dosing

Estimated Enrollment: 30
Study Start Date: October 2005
Estimated Study Completion Date: October 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00377078

Contacts
Contact: William B Greenough, III, MD 410-550-0782 trigsby@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: William B Greenough, III, M.D.    410-550-0782    trigsby@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Ventria Bioscience
Investigators
Principal Investigator: William B Greenough, III, MD Johns Hopkins University
Study Director: Delia Bethell, Ph.D. Ventria Bioscience
Study Chair: Delia Bethell, Ph.D. Ventria Bioscience
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00377078     History of Changes
Other Study ID Numbers: CP-VB-04-02
Study First Received: September 14, 2006
Last Updated: September 14, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
recombinant human lactoferrin

Additional relevant MeSH terms:
Lactoferrin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014