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Anti-pseudomonas IgY to Prevent Infections in Cystic Fibrosis (PseudIgY)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Immunsystem AB
ClinicalTrials.gov Identifier:
NCT00633191
First received: March 4, 2008
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

Hypothesis: Daily gargling with specific avian antibodies against Pseudomonas aeruginosa will prevent infections with this bacteria in patients with Cystic fibrosis (CF).


Condition Intervention Phase
Cystic Fibrosis
Infection
Pseudomonas Aeruginosa
Drug: Anti-pseudomonas IgY gargle
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Post Marketing Study of Anti-pseudomonas IgY in Prevention of Recurrence of Pseudomonas Aeruginosa Infections Infections in Cystic Fibrosis (CF) Patients

Resource links provided by NLM:


Further study details as provided by Immunsystem AB:

Primary Outcome Measures:
  • Sputum culture positive for Pseudomonas aeruginosa [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pulmonary function [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: November 2003
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anti-pseudomonas IgY gargle
Intervention: Gargles with anti-pseudomonas IgY every night
Drug: Anti-pseudomonas IgY gargle
Gargle (solution), > 5FKU, every night after toothbrushing, life-long
Other Names:
  • oral immunotherapy
  • Yolk antiboidies
No Intervention: 2, control
Intervention: No oral IgY treatment

Detailed Description:

"Anti-pseudomonas IgY" is prepared from eggs of hens that have been vaccinated with Pseudomonas aeruginosa. The hens farm is under veterinary control according to Swedish and FDA rules. The drug is prepared with a water dilution method by Fresenius-Kabi AB according to GMP standards (approved by Swedish MPA). Patients with CF who are intermittently but not chronically infected with P. aeruginosa get a short course of antibiotics to eradicate the bacteria. Thereafter they start to gargle with a solution of "anti-pseudomonas IgY" every night to prevent a new infection. Preliminary results have shown that it takes a significantly longer time to get a new infection and that the patients get fewer infections than control patients. In addition, they have not got any of the otherwise for CF patients common new opportunistic bacteria or fungi (B. Cepacia, S. Maltophilia, A. Xylosoxidans, atypical Mycobacteria, Aspergillus Fumigatus). The use of antibiotics is greatly diminished. The lung functions and nutritional conditions are maintained good.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of cystic fibrosis
  • Colonized with Pseudomonas aeruginosa
  • informed consent

Exclusion Criteria:

  • Egg allergy
  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: NCT00633191

Locations
Sweden
Cystic fibrosis centre,Children´s University Hospital
Uppsala, Sweden, SE-751 85
Sponsors and Collaborators
Immunsystem AB
Investigators
Principal Investigator: Annika Hollsing, MD, PhD Uppsala Children´s University Hospital
  More Information

Publications:

Responsible Party: Immunsystem AB
ClinicalTrials.gov Identifier: NCT00633191     History of Changes
Other Study ID Numbers: Pseud-IgY-1
Study First Received: March 4, 2008
Last Updated: September 3, 2014
Health Authority: Sweden: Medical Products Agency

Keywords provided by Immunsystem AB:
Cystic fibrosis
Prevention
Infection
Pseudomonas aeruginosa
Gargle

Additional relevant MeSH terms:
Communicable Diseases
Cystic Fibrosis
Fibrosis
Infection
Pseudomonas Infections
Bacterial Infections
Digestive System Diseases
Genetic Diseases, Inborn
Gram-Negative Bacterial Infections
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014