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

NCT01616862 | Completed

• 1 other identifier: 274342
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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).

Conditions

Pseudomonas Aeruginosa; Cystic Fibrosis

Keywords

Pseudomonas aeruginosa; cystic fibrosis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 5 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Biological parents of children younger than 5 years of age or older than 20 years of age.
• Step parents.

Sponsors & Collaborators

• Zafer Soultan: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Related Publications (4)

• 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

  BACKGROUND

• 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.

  PMID: 9196095 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 13955349 BACKGROUND

MeSH Terms

Conditions

Pseudomonas Infections; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Zafer Soultan, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: June 12, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 2, 2015

Record last verified: 2015-05

Locations

US (1)