The Carrier Rates of Pseudomonas Aeruginosa in Family Members of Children With Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT01616862|
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : June 2, 2015
|Condition or disease|
|Pseudomonas Aeruginosa Cystic Fibrosis|
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.
Parents will be asked to complete questionnaires at one routine, clinic visit, have nasal and throat cultures collected during their child's routine scheduled visit and again 3-4 months later (at another routine visit). The investigators are also asking permission to review the medical records of their child with CF.
|Study Type :||Observational|
|Actual Enrollment :||53 participants|
|Official Title:||The Carrier Rates of Pseudomonas Aeruginosa in Family Members of Children With Cystic Fibrosis|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||August 2013|
U.S. FDA Resources
Parents of PA positive CF children
parents of children with cystic fibrosis who are positive for Pseudomonas aeruginosa
parents of Pa negative CF children
parents of children with cystic fibrosis who are negative for pseudomonas aeruginosa
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616862
|United States, New York|
|SUNY Upstate Medical University|
|Syracuse, New York, United States, 13210|
|Principal Investigator:||Zafer Soultan, MD||State University of New York - Upstate Medical University|