Evaluation of the Emission Distance of P. Aeruginosa From the Respiratory Tract of People With Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00531531
Recruitment Status : Completed
First Posted : September 19, 2007
Last Update Posted : August 23, 2011
Italian Cystic Fibrosis Research Foundation
Ospedale Meyer
Information provided by (Responsible Party):
Filippo Festini, University of Florence

Brief Summary:

It is well known that an association exists between the acquisition of some respiratory pathogens and prognosis of CF people. About 57 % of patients has a lung infection due to P.aeruginosa (PA). Transmission of PA between CF patients is possible and several prevention measures are recommended. Among these measures, all international guidelines recommend that CF people maintain a minimum distance of 1 meter between them. However, this recommendation is not supported by specific studies and scientific evidence. In other words, the investigators don't know if this measure is sufficient or excessive, as it is based only on a theoretical rationale.

This study aims at measuring experimentally the distance that can be reached by PA emitted from airways of colonized CF patients during cough and during conversation.

To this purpose, the investigators will evacuate the presence of PA on surfaces placed at 4 different distances from patients, through the collection of 8 swabs, 4 of which following cough and 4 following conversation. Swabs will be collected on sterile surfaces comprised between tra 0 - 0,5 mt; 0,5 -1,00 mt.; 1,00 - 1,5 mt and 1.5-2 mt.

All the PA-positive CF patients of the CF Centre of Tuscany aged 14 or more will be recruited.

Condition or disease
Cystic Fibrosis

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Control and Prevention of Respiratory Infections in Cystic Fibrosis Patients: an Evaluation of the Emission Distance of P. Aeruginosa From the Respiratory Tract of Infected Persons Through Coughing and Conversation.
Study Start Date : September 2007
Primary Completion Date : August 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Primary Outcome Measures :
  1. Prevalence of surface samples positive for PA [ Time Frame: six months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People with CF attending the CF Center of Tuscany, aged 14 or older, with documented pulmonary Pseudomnas aeruginosa infection.

Inclusion Criteria:

  • Diagnosis of CF
  • Age 14 or older.
  • PA infection documented by the most recent expectorate culture available, no more than 3 months old.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00531531

Cystic Fibrosis Center of Tuscany, Meyer Hospital
Florence, Italy, 50132
Sponsors and Collaborators
University of Florence
Italian Cystic Fibrosis Research Foundation
Ospedale Meyer
Study Chair: Filippo Festini, BN, BSN, RN University of Florence, Italy
Study Director: Cesare Braggion, MD Cystic Fibrosis Center, Meyer Hospital Florence

Responsible Party: Filippo Festini, Associate Professor, University of Florence Identifier: NCT00531531     History of Changes
Other Study ID Numbers: FFC#16/2007
First Posted: September 19, 2007    Key Record Dates
Last Update Posted: August 23, 2011
Last Verified: August 2011

Keywords provided by Filippo Festini, University of Florence:
pulmonary infection

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases