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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616862
• Other study ID #: 274342
• Status: Completed
• Phase: N/A
• First received: January 9, 2012
• Last updated: May 29, 2015
• Start date: February 2012
• Est. completion date: August 2013

Study information

• Verified date: May 2015
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 19 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Pseudomonas Aeruginosa
• Pseudomonas Infections

Locations

Country	Name	City	State
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
Zafer Soultan

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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.

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No