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

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).

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis; 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.

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 19 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary objective: the incidence of Pseudomonas aeruginosa colonization in the upper respiratory tract of parents of children with CF.	Collection of nasal and oropharyngeal swabs will be obtained from parents living with patients at enrollment and after 3 months.	6 months
Primary objective: the incidence of Pseudomonas aeruginosa colonization in the upper respiratory tract of parents of children with CF.	Collection of nasal and oropharyngeal swabs will be obtained from parents living with patients at enrollment and after 3 months.	Day 0

Collaborators and Investigators

• Sponsor: Zafer Soultan
• Investigators: Principal Investigator: Zafer Soultan, MD, State University of New York - Upstate Medical University

Publications and helpful links

General Publications

• Microbiology and infectious disease in cystic fibrosis. Clinical Practice Guidelines for Cystic fibrosis; Cystic Fibrosis Foundation; Appendix V111, Volume V, Section I May 17-18, 1994
• Kerem E, Rave-Harel N, Augarten A, Madgar I, Nissim-Rafinia M, Yahav Y, Goshen R, Bentur L, Rivlin J, Aviram M, Genem A, Chiba-Falek O, Kraemer MR, Simon A, Branski D, Kerem B. A cystic fibrosis transmembrane conductance regulator splice variant with partial penetrance associated with variable cystic fibrosis presentations. Am J Respir Crit Care Med. 1997 Jun;155(6):1914-20. doi: 10.1164/ajrccm.155.6.9196095.
• Joel Moss form Pulmonary-Critical Care Medicine Branch, NHLBI, National Institutes of Health, Bethesda, Maryland, presented data stating that carriers of a CFTR gene mutations can be colonized by Pseudomonas aeruginoa. The data presented at The American Thoracic Society International Conference - 2005; in a seminar on Pseudomonas aeruginosa.
• HUANG NN, SHEN KT. Staphylococcal carrier rates of patients with cystic fibrosis and of members of their families. J Pediatr. 1963 Jan;62:36-43. doi: 10.1016/s0022-3476(63)80068-2. No abstract available.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: January 9, 2012
• First Submitted That Met QC Criteria: June 8, 2012
• First Posted (ESTIMATE): June 12, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 2, 2015
• Last Update Submitted That Met QC Criteria: May 29, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: cystic fibrosis; Pseudomonas aeruginosa
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pancreatic Diseases; Fibrosis; Cystic Fibrosis; Pseudomonas Infections
• Other Study ID Numbers: 274342