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

This study has been completed.
Sponsor:
Collaborators:
Italian Cystic Fibrosis Research Foundation, Verona, Italy
Ospedale Meyer
Information provided by (Responsible Party):
Filippo Festini, University of Florence
ClinicalTrials.gov Identifier:
NCT00531531
First received: September 18, 2007
Last updated: August 22, 2011
Last verified: August 2011
  Purpose

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
Cystic Fibrosis

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of Florence:

Primary Outcome Measures:
  • Prevalence of surface samples positive for PA [ Time Frame: six months ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: September 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years to 60 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  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: NCT00531531

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

No publications provided

Responsible Party: Filippo Festini, Associate Professor, University of Florence
ClinicalTrials.gov Identifier: NCT00531531     History of Changes
Other Study ID Numbers: FFC#16/2007
Study First Received: September 18, 2007
Last Updated: August 22, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University of Florence:
pulmonary infection
transmission
P.Aeruginosa
surfaces

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

ClinicalTrials.gov processed this record on November 27, 2014