Anti-pseudomonas IgY to Prevent Infections in Cystic Fibrosis (PseudIgY)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Sputum culture positive for Pseudomonas aeruginosa [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
- Pulmonary function [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2003 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1, IgY treated
Gargles witn anti-pseudomonas IgY every night
|
Drug: Anti-pseudomonas IgY gargle
Gargle (solution), > 5FKU, every night after toothbrushing, life-long
|
| No Intervention: 2, control |
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 |
Inclusion Criteria:
- Clinical diagnosis of cystic fibrosis
- Colonized with Pseudomonas aeruginosa
- informed consent
Exclusion Criteria:
- Egg allergy
Contacts and Locations| Sweden | |
| Cystic fibrosis centre,Children´s University Hospital | |
| Uppsala, Sweden, SE-751 85 | |
| Study Director: | Hans Kollberg, Professor MD | Immunsystem AB |
| Principal Investigator: | Annika Hollsing, MD, PhD | Uppsala Children´s University Hospital |
More Information
No publications provided
| Responsible Party: | Hans Kollberg, Professor, Immunsystem AB |
| ClinicalTrials.gov Identifier: | NCT00633191 History of Changes |
| Other Study ID Numbers: | Pseud-IgY-1 |
| Study First Received: | March 4, 2008 |
| Last Updated: | March 23, 2012 |
| Health Authority: | Sweden: Medical Products Agency |
Keywords provided by Immunsystem AB:
|
Cystic fibrosis Prevention Infection Pseudomonas aeruginosa Gargle |
Additional relevant MeSH terms:
|
Cystic Fibrosis Fibrosis Pseudomonas Infections Pancreatic Diseases Digestive System Diseases Lung Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes Gram-Negative Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 23, 2013