The Carrier Rates of Pseudomonas Aeruginosa in Family Members of Children With Cystic Fibrosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by State University of New York - Upstate Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Zafer Soultan, SUNY Upstate Medical University
ClinicalTrials.gov Identifier:
NCT01616862
First received: January 9, 2012
Last updated: June 8, 2012
Last verified: June 2012
  Purpose

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).


Condition
Pseudomonas Aeruginosa
Cystic Fibrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Carrier Rates of Pseudomonas Aeruginosa in Family Members of Children With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • Primary objective: the incidence of Pseudomonas aeruginosa colonization in the upper respiratory tract of parents of children with CF. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Collection of nasal and oropharyngeal swabs will be obtained from parents living with patients at enrollment and after 3 months.


Estimated Enrollment: 150
Study Start Date: February 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   5 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Biological parents of children with cystic fibrosis who are treated at Upstate Medical University. Children's age is more than 5 yrs and less than 20 yrs.

Criteria

Inclusion Criteria:

  • Biological parents of children with CF will be invited to participate and included if their children meet the following criteria:

    • children's age is more than 5 years and less than 20 years of age.

Exclusion Criteria:

  • Biological parents of children younger than 5 years of age or older than 20 years of age.
  • Step parents.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616862

Contacts
Contact: Zafer Soultan, MD 315-464-6323 soultanz@upstate.edu
Contact: Ran D. Anbar, MD 315-464-6323 anbarr@upstate.edu

Locations
United States, New York
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Principal Investigator: Zafer Soultan, MD         
Sponsors and Collaborators
Zafer Soultan
Investigators
Principal Investigator: Zafer Soultan, MD State University of New York - Upstate Medical University
  More Information

Publications:
Responsible Party: Zafer Soultan, Associate professor, SUNY Upstate Medical University
ClinicalTrials.gov Identifier: NCT01616862     History of Changes
Other Study ID Numbers: 274342
Study First Received: January 9, 2012
Last Updated: June 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
Pseudomonas aeruginosa
cystic fibrosis

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 July 24, 2014