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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

March 4, 2008
September 3, 2014
November 2003
December 2018   (final data collection date for primary outcome measure)
Sputum culture positive for Pseudomonas aeruginosa [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00633191 on ClinicalTrials.gov Archive Site
Pulmonary function [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Anti-pseudomonas IgY to Prevent Infections in Cystic Fibrosis
Post Marketing Study of Anti-pseudomonas IgY in Prevention of Recurrence of Pseudomonas Aeruginosa Infections Infections in Cystic Fibrosis (CF) Patients

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

"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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Cystic Fibrosis
  • Infection
  • Pseudomonas Aeruginosa
Drug: Anti-pseudomonas IgY gargle
Gargle (solution), > 5FKU, every night after toothbrushing, life-long
Other Names:
  • oral immunotherapy
  • Yolk antiboidies
  • Active Comparator: Anti-pseudomonas IgY gargle
    Intervention: Gargles with anti-pseudomonas IgY every night
    Intervention: Drug: Anti-pseudomonas IgY gargle
  • No Intervention: 2, control
    Intervention: No oral IgY treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
December 2018
December 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Egg allergy
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00633191
Pseud-IgY-1
Yes
Immunsystem AB
Immunsystem AB
Not Provided
Principal Investigator: Annika Hollsing, MD, PhD Uppsala Children´s University Hospital
Immunsystem AB
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP