Clinical Trial: The Carrier Rates of Pseudomonas Aeruginosa in Family Members of Children With Cystic Fibrosis
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: The Carrier Rates of Pseudomonas Aeruginosa in Family Members of Children With Cystic Fibrosis
Brief Summary: Pseudomonas aeruginosa (Pa) is the bacterium that causes one of the most consequential lung infections in people with CF. Many young children do not have Pa in their lungs but will become infected as they get older. The investigators want to learn more about how Pa is passed from person to person, especially to someone with Cystic Fibrosis (CF).
Detailed Summary:
People with CF (cystic fibrosis) often have lung infections which occur repeatedly or worsen over time. The lung infections are most often caused by bacteria. Pseudomonas aeruginosa (Pa) is the bacterium that causes one of the most consequential lung infections in people with CF. Many young children do not have Pa in their lungs but will become infected as they get older. The investigators want to learn more about how Pa is passed from person to person, especially to someone with CF. The respiratory secretions of someone colonized with Pa can transmit or pass on the bacterium. The bacterium can be passed through direct contact by two individuals kissing or touching hands. Another way to pass Pa is by indirect contact such as touching an object like an eating utensil or drinking glass that has been used by someone with Pa.
There are many unanswered questions about Pa lung infections in people with CF. For example, it is not known why some people with CF develop Pa lung infections earlier than others. Nor is it known why it is difficult to eradicate Pa in some children and why some children's condition to deteriorate quicker than other after becoming infected with Pa.
Biological parents of children with CF are carriers of one CF causing gene mutation. It is also possible that they are carriers of additional, but milder, CF-related gene mutations. It is possible that the carrier status of the parents of CF children place them at risk of acquiring and carrying Pa in their lungs.
Biological parents of children who have CF will be asked to participate. This study plans to assess the frequency of Pa in biological parents and to correlate the clinical and microbiological status of CF children with PA carrier rates of their parents.
Sponsor: Zafer Soultan
Current Primary Outcome:
- Primary objective: the incidence of Pseudomonas aeruginosa colonization in the upper respiratory tract of parents of children with CF. [ Time Frame: 6 months ]Collection of nasal and oropharyngeal swabs will be obtained from parents living with patients at enrollment and after 3 months.
- Primary objective: the incidence of Pseudomonas aeruginosa colonization in the upper respiratory tract of parents of children with CF. [ Time Frame: Day 0 ]Collection of nasal and oropharyngeal swabs will be obtained from parents living with patients at enrollment and after 3 months.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: State University of New York - Upstate Medical University
Dates:
Date Received: January 9, 2012
Date Started: February 2012
Date Completion:
Last Updated: May 29, 2015
Last Verified: May 2015
