Anti-Pseudomonas IgY to Prevent Infections in Cystic Fibrosis - Full Text View

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 I Phase II

Genetics Home Reference related topics:

cystic fibrosis

MedlinePlus related topics:

Cystic Fibrosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Official Title:	Post Marketing Study of Anti-Pseudomonas IgY in Prevention of Recurrence of Pseudomonas Aeruginosa Infections Infections in Cystic Fibrosis (CF) Patients

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 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1, IgY treated: Active Comparator Gargles witn anti-pseudomonas IgY every night	Drug: Anti-pseudomonas IgY gargle Gargle (solution), > 5FKU, every night after toothbrushing, life-long
2, control: No Intervention

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

Ages Eligible for Study:	5 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of cystic fibrosis
Intermittently colonized with Pseudomonas aeruginosa
informed consent

Exclusion Criteria:

Chronically colonized with Pseudomonas aeruginosa
Egg allergy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633191

Contacts


Contact: Hans Kollberg, Professor, MD, PhD	+46-18-104321	hans.kollberg@kbh.uu.se

Contact: Elin Nilsson, PhD student	+46-70-2329093	elin.nilsson@medsci.uu.se

Locations


Sweden
	Uppsala Children´s University Hospital	Recruiting
	Uppsala, Sweden, SE- 751 85
	Contact: Hans Kollberg, Professor +46-18-104321 hans.kollberg@kbh.uu.se
	Contact: Elin Nilsson, PhD student +46-70-2329093 elin.nilsson@medsci.uu.se
	Principal Investigator: Annika Hollsing, MD,PhD
	Children´s University Hospital	Recruiting
	Uppsala, Sweden, SE-751 85
	Contact: Hans Kollberg, Professor +46-18-104321 hans.kollberg@kbh.uu.se
	Contact: Elin Nilsson, PhD student +46-70-2329093 elin.nilsson@medsci.uu.se
	Principal Investigator: Annika Hollsing, MD, PhD

Sponsors and Collaborators

Immunsystem AB

Investigators


Study Director:	Hans Kollberg, Professor MD	Immunsystem AB

Principal Investigator:	Annika Hollsing, MD, PhD	Uppsala Children´s University Hospital

More Information

Publications of Results:

Kollberg H, Carlander D, Olesen H, Wejåker PE, Johannesson M, Larsson A. Oral administration of specific yolk antibodies (IgY) may prevent Pseudomonas aeruginosa infections in patients with cystic fibrosis: a phase I feasibility study. Pediatr Pulmonol. 2003 Jun;35(6):433-40.

Responsible Party:	Immunsystem AB, Dag Hammarskjölds väg 26, 751 83 Uppsala, Sweden ( Hans Kollberg, Professor, MD, PhD, Director of clinical investigations )
Study ID Numbers:	Pseud-IgY-1
First Received:	March 4, 2008
Last Updated:	March 10, 2008
ClinicalTrials.gov Identifier:	NCT00633191
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Immunsystem AB:

Cystic fibrosis

Prevention

Infection

Pseudomonas aeruginosa

Gargle

Study placed in the following topic categories:

Digestive System Diseases

Genetic Diseases, Inborn

Respiratory Tract Diseases

Cystic Fibrosis

Fibrosis

Lung Diseases

Infant, Newborn, Diseases

Pancreatic Diseases

Cystic fibrosis

Recurrence

Additional relevant MeSH terms:

Communicable Diseases

Pathologic Processes

Infection

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	Immunsystem AB
Information provided by:	Immunsystem AB
ClinicalTrials.gov Identifier:	NCT00633191